Page last updated: 2024-11-04

vorinostat and Local Neoplasm Recurrence

vorinostat has been researched along with Local Neoplasm Recurrence in 41 studies

Vorinostat: A hydroxamic acid and anilide derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used in the treatment of CUTANEOUS T-CELL LYMPHOMA and SEZARY SYNDROME.
vorinostat : A dicarboxylic acid diamide comprising suberic (octanedioic) acid coupled to aniline and hydroxylamine. A histone deacetylase inhibitor, it is marketed under the name Zolinza for the treatment of cutaneous T cell lymphoma (CTCL).

Research Excerpts

ExcerptRelevanceReference
" We sought to study vorinostat (VOR), a histone deacetylase inhibitor, in combination with bevacizumab (BEV) and daily metronomic temozolomide (TMZ) in a Phase I/II trial in recurrent high-grade gliomas (HGGs)."9.27Phase I/II trial of vorinostat, bevacizumab, and daily temozolomide for recurrent malignant gliomas. ( Desjardins, A; Friedman, HS; Herndon, JE; Lipp, ES; McSherry, F; Miller, E; Peters, KB; Reardon, DA, 2018)
"Mogamulizumab significantly prolonged progression-free survival compared with vorinostat, and could provide a new, effective treatment for patients with mycosis fungoides and, importantly, for Sézary syndrome, a subtype that represents a major therapeutic challenge in cutaneous T-cell lymphoma."9.27Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. ( Bagot, M; Dalle, S; Duvic, M; Dwyer, K; Elmets, C; Eradat, H; Fierro, MT; Fisher, DC; Geskin, LJ; Grebennik, DO; Greer, J; Halwani, A; Horwitz, SM; Hudgens, S; Humphrey, JS; Khot, A; Kim, EJ; Kim, YH; Leoni, M; Moriya, J; Morris, S; Moskowitz, AJ; Musiek, A; Ortiz-Romero, PL; Pinter-Brown, L; Poligone, B; Porcu, P; Pro, B; Rook, AH; Scarisbrick, J; Shustov, A; Sokol, L; Tobinai, K; Tokura, Y; Tsianakas, A; Vermeer, M; Whittaker, S; Zinzani, PL, 2018)
"A phase 1 study with carfilzomib and vorinostat was conducted in 20 B-cell lymphoma patients."9.22Phase 1 trial of carfilzomib (PR-171) in combination with vorinostat (SAHA) in patients with relapsed or refractory B-cell lymphomas. ( Barr, PM; Bose, P; Cebula, EM; Feng, C; Fisher, RI; Friedberg, JW; Grant, S; Herr, M; Hogan, KT; Holkova, B; Kmieciak, M; Peterson, DR; Pierce, E; Rollins, AD; Sankala, H; Shrader, E; Tombes, MB; Wan, W; Weir-Wiggins, C; Yazbeck, VY, 2016)
"In this randomised trial, vorinostat given as a second-line or third-line therapy did not improve overall survival and cannot be recommended as a therapy for patients with advanced malignant pleural mesothelioma."9.20Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial. ( Baas, P; Buikhuisen, WA; Calvert, H; Chu, Q; Eberhardt, WE; Fennell, D; Fukuoka, K; Gaafar, RM; Hillerdal, G; Kindler, HL; Krug, LM; Lafitte, JJ; Lubiniecki, GM; Manegold, C; Öhman, R; Plummer, R; Smith, M; Sun, X; Tsao, AS, 2015)
"We aimed to assess efficacy and tolerability of vorinostat in combination with bortezomib for treatment of patients with relapsed or refractory multiple myeloma."9.17Vorinostat or placebo in combination with bortezomib in patients with multiple myeloma (VANTAGE 088): a multicentre, randomised, double-blind study. ( Anderson, KC; Blacklock, H; Dimopoulos, M; Eid, JE; Facon, T; Goldschmidt, H; Graef, T; Hajek, R; Houp, J; Hungria, V; Lonial, S; Palumbo, A; Qi, J; Rosinol, L; Siegel, DS; Spencer, A; Sun, L; Vuocolo, S; Williams, C, 2013)
" Suberoylanilidehydroxamic acid (SAHA=vorinostat) is the most clinical advanced compound of the class and was approved by the US FDA in October 2006 for the treatment of refractory cutaneous T-cell lymphoma."9.16Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma or leukemia. ( Abel, U; Deubzer, HE; Eisenmenger, A; Karapanagiotou-Schenkel, I; Kulozik, A; Milde, T; Oehme, I; Witt, O; Witt, R, 2012)
"A phase I study was conducted to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) for the combination of vorinostat with bevacizumab and CPT-11 in recurrent glioblastoma."9.16Phase I trial of vorinostat combined with bevacizumab and CPT-11 in recurrent glioblastoma. ( Brem, S; Chinnaiyan, P; Chowdhary, S; Kahali, S; Murtagh, R; Pan, E; Potthast, L; Prabhu, A; Rojiani, A; Sarcar, B; Tsai, YY; Yu, HM, 2012)
"Vorinostat, a histone deacetylase inhibitor, represents a rational therapeutic target in glioblastoma multiforme (GBM)."9.14Phase II trial of vorinostat in recurrent glioblastoma multiforme: a north central cancer treatment group study. ( Ames, MM; Buckner, JC; Fantin, VR; Flynn, PJ; Galanis, E; Giannini, C; Hardwick, JS; Jaeckle, KA; Loboda, A; Maurer, MJ; Moore, DF; Nebozhyn, M; Reid, JM; Reilly, JF; Richon, VM; Scheithauer, B; Zwiebel, J, 2009)
"Vorinostat is well tolerated but had minimal activity as a single agent in unscreened patients with recurrent platinum-refractory ovarian or primary peritoneal carcinoma."9.13A phase II study of vorinostat in the treatment of persistent or recurrent epithelial ovarian or primary peritoneal carcinoma: a Gynecologic Oncology Group study. ( Bender, DP; Hoffman, JS; Modesitt, SC; Sill, M, 2008)
"Double epigenetic modulation of Gem/Bu/Mel with azacitidine/vorinostat is feasible and highly active in patients with refractory/poor-risk relapsed lymphomas, warranting further evaluation."7.83Double epigenetic modulation of high-dose chemotherapy with azacitidine and vorinostat for patients with refractory or poor-risk relapsed lymphoma. ( Ahmed, S; Alousi, A; Anderlini, P; Andersson, BS; Bashir, Q; Champlin, R; Dabaja, B; Fanale, M; Gulbis, A; Hosing, C; Jones, RB; Myers, A; Nieto, Y; Oki, Y; Pinnix, C; Popat, U; Qazilbash, M; Shah, N; Shpall, EJ; Thall, PF; Valdez, BC; Wei, W, 2016)
"Vorinostat (400 mg) was administered orally on days 1 to 5 and 8 to 12 before bortezomib (1."6.87A Phase II Trial of Bortezomib and Vorinostat in Mantle Cell Lymphoma and Diffuse Large B-cell Lymphoma. ( Badros, AZ; Baz, R; Bose, P; Coppola, D; Flowers, C; Grant, S; Holkova, B; Kimball, A; Kmieciak, M; Lin, HY; Morgan, D; Parekh, S; Perkins, EB; Reich, RR; Richards, KL; Roberts, JD; Ruan, J; Sankala, H; Shafer, D; Shea, T; Shrader, E; Sokol, L; Strair, R; Sullivan, D; Tombes, MB; Yazbeck, V; Zhao, X, 2018)
"Vorinostat is a histone deacetylase inhibitor that has radiosensitizing properties."6.80Phase I Study of Vorinostat as a Radiation Sensitizer with 131I-Metaiodobenzylguanidine (131I-MIBG) for Patients with Relapsed or Refractory Neuroblastoma. ( Chen, E; Cohn, SL; Courtier, J; Czarnecki, S; DuBois, SG; Geier, E; Giacomini, K; Goodarzian, F; Granger, MM; Groshen, S; Haas-Kogan, DA; Hawkins, R; Jackson, H; Marachelian, A; Matthay, KK; Park, JR; Shimada, H; Tsao-Wei, D; Villablanca, JG; Weiss, B; Yang, X; Yanik, GA, 2015)
"Multiple myeloma is a neoplastic plasma cell disorder that is characterized by clonal proliferation of plasma cells in the bone marrow, monoclonal protein in the blood and/or urine, and associated organ dysfunction and biomarkers."6.52Role of Histone Deacetylase Inhibitors in Relapsed Refractory Multiple Myeloma: A Focus on Vorinostat and Panobinostat. ( Afifi, S; Azimi, M; Landgren, O; Lendvai, N; Michael, A; Rodriguez, M, 2015)
" We sought to study vorinostat (VOR), a histone deacetylase inhibitor, in combination with bevacizumab (BEV) and daily metronomic temozolomide (TMZ) in a Phase I/II trial in recurrent high-grade gliomas (HGGs)."5.27Phase I/II trial of vorinostat, bevacizumab, and daily temozolomide for recurrent malignant gliomas. ( Desjardins, A; Friedman, HS; Herndon, JE; Lipp, ES; McSherry, F; Miller, E; Peters, KB; Reardon, DA, 2018)
"Mogamulizumab significantly prolonged progression-free survival compared with vorinostat, and could provide a new, effective treatment for patients with mycosis fungoides and, importantly, for Sézary syndrome, a subtype that represents a major therapeutic challenge in cutaneous T-cell lymphoma."5.27Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. ( Bagot, M; Dalle, S; Duvic, M; Dwyer, K; Elmets, C; Eradat, H; Fierro, MT; Fisher, DC; Geskin, LJ; Grebennik, DO; Greer, J; Halwani, A; Horwitz, SM; Hudgens, S; Humphrey, JS; Khot, A; Kim, EJ; Kim, YH; Leoni, M; Moriya, J; Morris, S; Moskowitz, AJ; Musiek, A; Ortiz-Romero, PL; Pinter-Brown, L; Poligone, B; Porcu, P; Pro, B; Rook, AH; Scarisbrick, J; Shustov, A; Sokol, L; Tobinai, K; Tokura, Y; Tsianakas, A; Vermeer, M; Whittaker, S; Zinzani, PL, 2018)
"A phase 1 study with carfilzomib and vorinostat was conducted in 20 B-cell lymphoma patients."5.22Phase 1 trial of carfilzomib (PR-171) in combination with vorinostat (SAHA) in patients with relapsed or refractory B-cell lymphomas. ( Barr, PM; Bose, P; Cebula, EM; Feng, C; Fisher, RI; Friedberg, JW; Grant, S; Herr, M; Hogan, KT; Holkova, B; Kmieciak, M; Peterson, DR; Pierce, E; Rollins, AD; Sankala, H; Shrader, E; Tombes, MB; Wan, W; Weir-Wiggins, C; Yazbeck, VY, 2016)
"In this randomised trial, vorinostat given as a second-line or third-line therapy did not improve overall survival and cannot be recommended as a therapy for patients with advanced malignant pleural mesothelioma."5.20Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial. ( Baas, P; Buikhuisen, WA; Calvert, H; Chu, Q; Eberhardt, WE; Fennell, D; Fukuoka, K; Gaafar, RM; Hillerdal, G; Kindler, HL; Krug, LM; Lafitte, JJ; Lubiniecki, GM; Manegold, C; Öhman, R; Plummer, R; Smith, M; Sun, X; Tsao, AS, 2015)
"We aimed to assess efficacy and tolerability of vorinostat in combination with bortezomib for treatment of patients with relapsed or refractory multiple myeloma."5.17Vorinostat or placebo in combination with bortezomib in patients with multiple myeloma (VANTAGE 088): a multicentre, randomised, double-blind study. ( Anderson, KC; Blacklock, H; Dimopoulos, M; Eid, JE; Facon, T; Goldschmidt, H; Graef, T; Hajek, R; Houp, J; Hungria, V; Lonial, S; Palumbo, A; Qi, J; Rosinol, L; Siegel, DS; Spencer, A; Sun, L; Vuocolo, S; Williams, C, 2013)
"A phase I study was conducted to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) for the combination of vorinostat with bevacizumab and CPT-11 in recurrent glioblastoma."5.16Phase I trial of vorinostat combined with bevacizumab and CPT-11 in recurrent glioblastoma. ( Brem, S; Chinnaiyan, P; Chowdhary, S; Kahali, S; Murtagh, R; Pan, E; Potthast, L; Prabhu, A; Rojiani, A; Sarcar, B; Tsai, YY; Yu, HM, 2012)
" Suberoylanilidehydroxamic acid (SAHA=vorinostat) is the most clinical advanced compound of the class and was approved by the US FDA in October 2006 for the treatment of refractory cutaneous T-cell lymphoma."5.16Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma or leukemia. ( Abel, U; Deubzer, HE; Eisenmenger, A; Karapanagiotou-Schenkel, I; Kulozik, A; Milde, T; Oehme, I; Witt, O; Witt, R, 2012)
"Vorinostat, a histone deacetylase inhibitor, represents a rational therapeutic target in glioblastoma multiforme (GBM)."5.14Phase II trial of vorinostat in recurrent glioblastoma multiforme: a north central cancer treatment group study. ( Ames, MM; Buckner, JC; Fantin, VR; Flynn, PJ; Galanis, E; Giannini, C; Hardwick, JS; Jaeckle, KA; Loboda, A; Maurer, MJ; Moore, DF; Nebozhyn, M; Reid, JM; Reilly, JF; Richon, VM; Scheithauer, B; Zwiebel, J, 2009)
"Vorinostat is well tolerated but had minimal activity as a single agent in unscreened patients with recurrent platinum-refractory ovarian or primary peritoneal carcinoma."5.13A phase II study of vorinostat in the treatment of persistent or recurrent epithelial ovarian or primary peritoneal carcinoma: a Gynecologic Oncology Group study. ( Bender, DP; Hoffman, JS; Modesitt, SC; Sill, M, 2008)
"Double epigenetic modulation of Gem/Bu/Mel with azacitidine/vorinostat is feasible and highly active in patients with refractory/poor-risk relapsed lymphomas, warranting further evaluation."3.83Double epigenetic modulation of high-dose chemotherapy with azacitidine and vorinostat for patients with refractory or poor-risk relapsed lymphoma. ( Ahmed, S; Alousi, A; Anderlini, P; Andersson, BS; Bashir, Q; Champlin, R; Dabaja, B; Fanale, M; Gulbis, A; Hosing, C; Jones, RB; Myers, A; Nieto, Y; Oki, Y; Pinnix, C; Popat, U; Qazilbash, M; Shah, N; Shpall, EJ; Thall, PF; Valdez, BC; Wei, W, 2016)
"Vorinostat was given orally 200 mg twice daily continuously until progression or unacceptable toxicity."3.01Phase II study of the histone deacetylase inhibitor vorinostat (Suberoylanilide Hydroxamic Acid; SAHA) in recurrent or metastatic transitional cell carcinoma of the urothelium - an NCI-CTEP sponsored: California Cancer Consortium trial, NCI 6879. ( Aparicio, AM; Chatta, G; Frankel, P; Gandara, DR; Groshen, SG; Khoo, S; Lara, PN; Lenz, HJ; Newman, E; Quinn, DI; Tsao-Wei, DD; Twardowski, P; Wright, JJ, 2021)
"Vorinostat (400 mg) was administered orally on days 1 to 5 and 8 to 12 before bortezomib (1."2.87A Phase II Trial of Bortezomib and Vorinostat in Mantle Cell Lymphoma and Diffuse Large B-cell Lymphoma. ( Badros, AZ; Baz, R; Bose, P; Coppola, D; Flowers, C; Grant, S; Holkova, B; Kimball, A; Kmieciak, M; Lin, HY; Morgan, D; Parekh, S; Perkins, EB; Reich, RR; Richards, KL; Roberts, JD; Ruan, J; Sankala, H; Shafer, D; Shea, T; Shrader, E; Sokol, L; Strair, R; Sullivan, D; Tombes, MB; Yazbeck, V; Zhao, X, 2018)
"Vorinostat was administered orally 400 mg daily, 28 day cycles."2.84A phase 2 study of vorinostat in locally advanced, recurrent, or metastatic adenoid cystic carcinoma. ( Barrett, MT; Boerner, SA; Casetta, L; Chao, J; Chen, A; Goncalves, PH; Hansen, AR; Heilbrun, LK; Kummar, S; Lenkiewicz, E; LoRusso, PM; Malasi, S; Piekarz, RL; Pilat, MJ; Siu, LL; Smith, DW; Sukari, AW, 2017)
"In patients with HER2-positive metastatic breast cancer who had relapsed or progressed during trastuzumab therapy, we observed no DLTs with SAHA 200 mg twice daily combined with trastuzumab; however, there was insufficient statistical evidence that adding SAHA reversed trastuzumab resistance in these patients."2.84A Phase I/II study of suberoylanilide hydroxamic acid (SAHA) in combination with trastuzumab (Herceptin) in patients with advanced metastatic and/or local chest wall recurrent HER2-amplified breast cancer: a trial of the ECOG-ACRIN Cancer Research Group ( ( Bhalla, KN; Falkson, CI; Goldstein, LJ; Katherine Alpaugh, R; Klein, P; Meropol, NJ; Pellegrino, CM; Sledge, GW; Sparano, JA; Swaby, RF; Wang, M; Zhao, F, 2017)
"Fifteen patients with relapsed ovarian cancer were enrolled into this phase I study."2.80Phase I study of combination of vorinostat, carboplatin, and gemcitabine in women with recurrent, platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer. ( Berlin, S; Campos, S; Horowitz, N; Krasner, C; Lee, H; Liu, J; Matulonis, U; Obermayer, E; Penson, R; Whalen, C, 2015)
"Vorinostat is a histone deacetylase inhibitor that has radiosensitizing properties."2.80Phase I Study of Vorinostat as a Radiation Sensitizer with 131I-Metaiodobenzylguanidine (131I-MIBG) for Patients with Relapsed or Refractory Neuroblastoma. ( Chen, E; Cohn, SL; Courtier, J; Czarnecki, S; DuBois, SG; Geier, E; Giacomini, K; Goodarzian, F; Granger, MM; Groshen, S; Haas-Kogan, DA; Hawkins, R; Jackson, H; Marachelian, A; Matthay, KK; Park, JR; Shimada, H; Tsao-Wei, D; Villablanca, JG; Weiss, B; Yang, X; Yanik, GA, 2015)
"Vorinostat is an inhibitor of histone deacetylase 6, which acetylates tubulin and stabilizes microtubules."2.77Phase I study of vorinostat (suberoylanilide hydroxamic acid, NSC 701852) in combination with docetaxel in patients with advanced and relapsed solid malignancies. ( Bradley, D; Daignault, S; Dunn, R; Egorin, MJ; Hussain, M; Kalemkerian, GP; Schneider, BJ; Smith, DC, 2012)
"Oral vorinostat has limited single-agent activity in relapsed/refractory HL."2.77A phase 2 study of vorinostat for treatment of relapsed or refractory Hodgkin lymphoma: Southwest Oncology Group Study S0517. ( Cook, JR; Fisher, RI; Forman, SJ; Goldman, BH; Kirschbaum, MH; Rimsza, LM; Zain, JM, 2012)
"Oral vorinostat is a promising agent in FL and MZL, with an acceptable safety profile."2.76Phase II study of vorinostat for treatment of relapsed or refractory indolent non-Hodgkin's lymphoma and mantle cell lymphoma. ( Delioukina, M; Espinoza-Delgado, I; Forman, SJ; Frankel, P; Gandara, D; Kirschbaum, M; Matsuoka, D; Nademanee, A; Newman, E; Popplewell, L; Pullarkat, V; Pulone, B; Rotter, AJ; Zain, J, 2011)
"Vorinostat is a small molecule inhibitor of histone deacetylase, and has shown preclinical activity in non-small cell lung cancer (NSCLC)."2.74Vorinostat (NSC# 701852) in patients with relapsed non-small cell lung cancer: a Wisconsin Oncology Network phase II study. ( Dubey, S; Eickhoff, JC; Espinoza-Delgado, I; Groteluschen, DL; Hallahan, CM; Huie, MS; Kolesar, JM; Marcotte, SM; Schell, K; Schiller, JH; Traynor, AM; Weeks, HR; Wilding, G, 2009)
"Oral vorinostat 400 mg qd was generally well tolerated but did not demonstrate efficacy as defined by tumor response in this small group of heavily pre-treated patients."2.73Phase II trial of the histone deacetylase inhibitor vorinostat (Zolinza, suberoylanilide hydroxamic acid, SAHA) in patients with recurrent and/or metastatic head and neck cancer. ( Blumenschein, GR; Chen, C; Chiao, JH; Frankel, SR; Kies, MS; Kumar, AJ; Lu, C; Papadimitrakopoulou, VA; Ricker, JL, 2008)
" The maximum tolerated dose was 400 mg qd and 200 mg bid for continuous daily dosing and 300 mg bid for 3 consecutive days per week dosing."2.71Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer. ( Chiao, JH; Chu, E; Curley, T; Heaney, M; Kelly, WK; Krug, LM; MacGregore-Cortelli, B; Marks, PA; O'Connor, OA; Olgac, S; Richardson, S; Richon, VM; Scher, H; Schwartz, L; Secrist, JP; Tong, W, 2005)
"Multiple myeloma is a neoplastic plasma cell disorder that is characterized by clonal proliferation of plasma cells in the bone marrow, monoclonal protein in the blood and/or urine, and associated organ dysfunction and biomarkers."2.52Role of Histone Deacetylase Inhibitors in Relapsed Refractory Multiple Myeloma: A Focus on Vorinostat and Panobinostat. ( Afifi, S; Azimi, M; Landgren, O; Lendvai, N; Michael, A; Rodriguez, M, 2015)
"Six patients experienced disease progression."1.42Vorinostat for refractory or relapsing epidermotropic T-cell lymphoma: a retrospective cohort study of 15 patients. ( Brocard, A; Dréno, B; Knol, AC; Kogge, A; Peuvrel, L; Quéreux, G; Renaut, JJ; Saint-Jean, M; Volteau, C, 2015)

Research

Studies (41)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's6 (14.63)29.6817
2010's23 (56.10)24.3611
2020's12 (29.27)2.80

Authors

AuthorsStudies
Gong, Y1
Chen, W1
Chen, X1
He, Y1
Jiang, H1
Zhang, X1
Pan, L1
Ni, B1
Yang, F1
Xu, Y1
Zhang, Q1
Zhou, L1
Cheng, Y1
Schafer, ES1
Chao, K1
Stevens, AM1
Jo, E1
Hilsenbeck, SG1
Gossai, NP1
Doan, A1
Colace, SI1
Guinipero, T1
Otterson, D1
Kaplan, JA1
Hinson, A1
Pommert, L1
Wayne, AS1
Bhojwani, D1
Burke, MJ1
LeBlanc, FR1
Hasanali, ZS1
Stuart, A1
Shimko, S1
Sharma, K1
Leshchenko, VV1
Parekh, S2
Fu, H1
Zhang, Y3
Martin, MM1
Kester, M1
Fox, T1
Liao, J1
Loughran, TP1
Evans, J1
Pu, JJ1
Spurgeon, SE1
Aladjem, MI1
Epner, EM1
Pan, C3
Wu, QV4
Voutsinas, J4
Houlton, JJ3
Barber, B3
Futran, N3
Laramore, GE3
Liao, JJ3
Parvathaneni, U3
Martins, RG3
Fromm, JR4
Rodriguez, CP4
Alkhaldi, H1
Reinhardt, A1
Barnett, M1
Kundu, S1
Hosing, C2
Ramdial, J1
Saini, N1
Srour, S1
Alousi, A2
Kebriaei, P1
Popat, U2
Qazilbash, M2
Champlin, R2
Shpall, EJ2
Gulbis, A2
Shigle, TL1
Dabaja, B2
Pinnix, C2
Ahmed, S2
Steiner, R1
Andersson, BS2
Nieto, Y2
Siddiqi, T1
Frankel, P3
Beumer, JH1
Kiesel, BF1
Christner, S1
Ruel, C1
Song, JY1
Chen, R1
Kelly, KR1
Ailawadhi, S1
Kaesberg, P1
Popplewell, L2
Puverel, S1
Piekarz, R1
Forman, SJ3
Newman, EM1
Jiang, X1
Pillarisetty, VG1
Lee, SM1
Santana-Davila, R1
Goulart, B1
Baik, CS1
Chow, LQM1
Eaton, K1
Martins, R1
Puduvalli, VK1
Wu, J2
Yuan, Y1
Armstrong, TS1
Vera, E1
Xu, J1
Giglio, P1
Colman, H1
Walbert, T1
Raizer, J1
Groves, MD1
Tran, D1
Iwamoto, F1
Avgeropoulos, N1
Paleologos, N1
Fink, K1
Peereboom, D1
Chamberlain, M1
Merrell, R1
Penas Prado, M1
Yung, WKA1
Gilbert, MR1
Skelton, WP1
Turba, E1
Sokol, L3
Quinn, DI1
Tsao-Wei, DD1
Twardowski, P1
Aparicio, AM1
Chatta, G1
Wright, JJ1
Groshen, SG1
Khoo, S1
Lenz, HJ1
Lara, PN1
Gandara, DR1
Newman, E2
DuBois, SG2
Granger, MM2
Groshen, S2
Tsao-Wei, D2
Ji, L1
Shamirian, A1
Czarnecki, S2
Goodarzian, F2
Berkovich, R1
Shimada, H2
Villablanca, JG2
Vo, KT1
Pinto, N1
Mosse, YP1
Maris, JM1
Shusterman, S1
Cohn, SL2
Goldsmith, KC1
Weiss, B2
Yanik, GA2
Twist, CJ1
Irwin, MS1
Haas-Kogan, DA2
Park, JR2
Marachelian, A2
Matthay, KK2
Goncalves, PH1
Heilbrun, LK1
Barrett, MT1
Kummar, S1
Hansen, AR1
Siu, LL1
Piekarz, RL1
Sukari, AW1
Chao, J1
Pilat, MJ1
Smith, DW1
Casetta, L1
Boerner, SA1
Chen, A1
Lenkiewicz, E1
Malasi, S1
LoRusso, PM1
Ko, CY1
Lin, CH1
Chuang, JY1
Chang, WC1
Hsu, TI1
Chen, G1
Xu, Z1
Chang, G1
Hou, J1
Hu, L1
Yu, D1
Li, B1
Chang, S1
Xie, Y1
Wei, R1
Wu, H1
Xiao, W1
Sun, X2
Tao, Y1
Gao, L1
Dai, B1
Shi, J1
Zhu, W1
Goldstein, LJ1
Zhao, F1
Wang, M1
Swaby, RF1
Sparano, JA1
Meropol, NJ1
Bhalla, KN1
Pellegrino, CM1
Katherine Alpaugh, R1
Falkson, CI1
Klein, P1
Sledge, GW1
Voorhees, PM1
Gasparetto, C1
Moore, DT1
Winans, D1
Orlowski, RZ1
Hurd, DD1
Ghiaseddin, A1
Reardon, D1
Massey, W1
Mannerino, A1
Lipp, ES2
Herndon, JE2
McSherry, F2
Desjardins, A2
Randazzo, D1
Friedman, HS2
Peters, KB2
Miller, E1
Reardon, DA1
Kim, YH1
Bagot, M1
Pinter-Brown, L1
Rook, AH1
Porcu, P1
Horwitz, SM1
Whittaker, S1
Tokura, Y1
Vermeer, M1
Zinzani, PL1
Morris, S1
Kim, EJ1
Ortiz-Romero, PL1
Eradat, H1
Scarisbrick, J1
Tsianakas, A1
Elmets, C1
Dalle, S1
Fisher, DC1
Halwani, A1
Poligone, B1
Greer, J1
Fierro, MT1
Khot, A1
Moskowitz, AJ1
Musiek, A1
Shustov, A1
Pro, B1
Geskin, LJ1
Dwyer, K1
Moriya, J1
Leoni, M1
Humphrey, JS1
Hudgens, S1
Grebennik, DO1
Tobinai, K1
Duvic, M1
Yazbeck, V1
Shafer, D1
Perkins, EB1
Coppola, D1
Richards, KL1
Shea, T1
Ruan, J1
Strair, R1
Flowers, C1
Morgan, D1
Kmieciak, M2
Bose, P2
Kimball, A1
Badros, AZ1
Baz, R1
Lin, HY1
Zhao, X1
Reich, RR1
Tombes, MB2
Shrader, E2
Sankala, H2
Roberts, JD1
Sullivan, D1
Grant, S2
Holkova, B2
Tang, C1
Du, Y1
Liang, Q1
Cheng, Z1
Tian, J1
Kasamon, YL1
Chen, H1
de Claro, RA1
Nie, L1
Ye, J1
Blumenthal, GM1
Farrell, AT1
Pazdur, R1
Dimopoulos, M1
Siegel, DS1
Lonial, S1
Qi, J1
Hajek, R1
Facon, T1
Rosinol, L1
Williams, C1
Blacklock, H1
Goldschmidt, H1
Hungria, V1
Spencer, A1
Palumbo, A1
Graef, T1
Eid, JE1
Houp, J1
Sun, L1
Vuocolo, S1
Anderson, KC1
Kogge, A1
Volteau, C1
Saint-Jean, M1
Peuvrel, L1
Brocard, A1
Knol, AC1
Renaut, JJ1
Dréno, B1
Quéreux, G1
Yang, X1
Geier, E1
Chen, E1
Giacomini, K1
Hawkins, R1
Courtier, J1
Jackson, H1
Krug, LM2
Kindler, HL1
Calvert, H1
Manegold, C1
Tsao, AS1
Fennell, D1
Öhman, R1
Plummer, R1
Eberhardt, WE1
Fukuoka, K1
Gaafar, RM1
Lafitte, JJ1
Hillerdal, G1
Chu, Q1
Buikhuisen, WA1
Lubiniecki, GM1
Smith, M1
Baas, P1
Matulonis, U1
Berlin, S1
Lee, H1
Whalen, C1
Obermayer, E1
Penson, R1
Liu, J1
Campos, S1
Krasner, C1
Horowitz, N1
Yazbeck, VY1
Barr, PM1
Weir-Wiggins, C1
Rollins, AD1
Cebula, EM1
Pierce, E1
Herr, M1
Hogan, KT1
Wan, W1
Feng, C1
Peterson, DR1
Fisher, RI2
Friedberg, JW1
Afifi, S1
Michael, A1
Azimi, M1
Rodriguez, M1
Lendvai, N1
Landgren, O1
Valdez, BC1
Thall, PF1
Jones, RB1
Wei, W1
Myers, A1
Anderlini, P1
Shah, N1
Bashir, Q1
Oki, Y1
Fanale, M1
Galanis, E1
Jaeckle, KA1
Maurer, MJ1
Reid, JM1
Ames, MM1
Hardwick, JS1
Reilly, JF1
Loboda, A1
Nebozhyn, M1
Fantin, VR1
Richon, VM2
Scheithauer, B1
Giannini, C1
Flynn, PJ1
Moore, DF1
Zwiebel, J1
Buckner, JC1
Traynor, AM1
Dubey, S1
Eickhoff, JC1
Kolesar, JM1
Schell, K1
Huie, MS1
Groteluschen, DL1
Marcotte, SM1
Hallahan, CM1
Weeks, HR1
Wilding, G1
Espinoza-Delgado, I2
Schiller, JH1
Schneider, BJ1
Kalemkerian, GP1
Bradley, D1
Smith, DC1
Egorin, MJ1
Daignault, S1
Dunn, R1
Hussain, M1
Kirschbaum, M1
Zain, J1
Delioukina, M1
Pullarkat, V1
Matsuoka, D1
Pulone, B1
Rotter, AJ1
Nademanee, A1
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Kirschbaum, MH1
Goldman, BH1
Zain, JM1
Cook, JR1
Rimsza, LM1
Chinnaiyan, P1
Chowdhary, S1
Potthast, L1
Prabhu, A1
Tsai, YY1
Sarcar, B1
Kahali, S1
Brem, S1
Yu, HM1
Rojiani, A1
Murtagh, R1
Pan, E1
Witt, O1
Milde, T1
Deubzer, HE1
Oehme, I1
Witt, R1
Kulozik, A1
Eisenmenger, A1
Abel, U1
Karapanagiotou-Schenkel, I1
Kelly, WK1
O'Connor, OA1
Chiao, JH2
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MacGregore-Cortelli, B1
Tong, W1
Secrist, JP1
Schwartz, L1
Richardson, S1
Chu, E1
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Scher, H1
Blumenschein, GR1
Kies, MS1
Papadimitrakopoulou, VA1
Lu, C1
Kumar, AJ1
Ricker, JL1
Chen, C1
Frankel, SR1
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Johnstone, RW1
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Clinical Trials (16)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Phase I Study of the Aurora Kinase a Inhibitor MLN8237 in Combination With the Histone Deacetylase Inhibitor Vorinostat in Lymphoid Malignancies[NCT01567709]Phase 134 participants (Actual)Interventional2012-04-16Completed
A Single Arm Phase I/II Study of MK-3475 Combined With Vorinostat for Recurrent Unresectable and/or Metastatic Squamous Cell Head and Neck Cancer and Recurrent Unresectable and/or Metastatic Salivary Gland Malignancies[NCT02538510]Phase 1/Phase 250 participants (Actual)Interventional2015-10-08Completed
Phase II Study of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Recurrent or Metastatic Transitional Cell Carcinoma of the Urothelium[NCT00363883]Phase 214 participants (Actual)Interventional2006-06-30Terminated (stopped due to Trial stopped early for futility)
NANT 2011- 01: Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG With Vincristine and Irinotecan, or 131I-MIBG With Vorinostat for Resistant/Relapsed Neuroblastoma[NCT02035137]Phase 2114 participants (Actual)Interventional2014-07-31Completed
Phase II Study of Bevacizumab and Vorinostat for Recurrent WHO Grade IV Malignant Glioma Patients[NCT01738646]Phase 248 participants (Actual)Interventional2013-01-31Completed
Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma[NCT01728805]Phase 3372 participants (Actual)Interventional2012-11-30Completed
Phase II Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma[NCT05996185]Phase 236 participants (Anticipated)Interventional2024-01-31Not yet recruiting
An International, Multicenter, Randomized, Double-Blind Study of Vorinostat (MK-0683) or Placebo in Combination With Bortezomib in Patients With Multiple Myeloma[NCT00773747]Phase 3637 participants (Actual)Interventional2008-12-01Completed
A Multicentre Randomised Phase III Trial Comparing Pembrolizumab Versus Standard Chemotherapy for Advanced Pre-treated Malignant Pleural Mesothelioma[NCT02991482]Phase 3144 participants (Actual)Interventional2017-09-12Completed
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Oral Suberoylanilide Hydroxamic Acid (Vorinostat, MK-0683) in Patients With Advanced Malignant Pleural Mesothelioma Previously Treated With Systemic Chemotherapy[NCT00128102]Phase 3661 participants (Actual)Interventional2005-06-30Completed
Phase Ib/II Study of Combination of Vorinostat, Carboplatin and Gemcitabine + Vorinostat Maintenance in Women With Recurrent, Platinum-Sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer[NCT00910000]Phase 1/Phase 215 participants (Actual)Interventional2009-06-30Terminated (stopped due to Terminated due to unacceptable toxicity)
A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Indolent Non-Hodgkin's Lymphoma[NCT00253630]Phase 237 participants (Actual)Interventional2005-09-30Completed
Phase I/II Intra-patient Dose Escalation Study of Vorinostat in Children With Relapsed Solid Tumor, Lymphoma or Leukemia[NCT01422499]Phase 1/Phase 250 participants (Actual)Interventional2012-03-31Completed
Phase I/II Clinical Trial of Vorinostat in Patients With Recurrent and/or Metastatic Breast Cancer[NCT00416130]Phase 1/Phase 249 participants (Anticipated)Interventional2007-01-31Active, not recruiting
IGHID 11424 - A Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection (The VOR VAX Study)[NCT02707900]Phase 16 participants (Actual)Interventional2016-03-31Terminated (stopped due to Manufacturing of the AGS-004 HIV vaccine by Argos could no longer be provided.)
A Phase I/II Study of Romidepsin in Combination With Abraxane in Patients With Metastatic Inflammatory Breast Cancer[NCT01938833]Phase 1/Phase 29 participants (Actual)Interventional2014-04-30Terminated (stopped due to Closed by Sponsor)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Progression Free Survival

The Kaplan Meier methods will be used to estimate progression free survival. (NCT02538510)
Timeframe: Up to 2 years

InterventionMonths (Mean)
Head and Neck Squamous Cell Carcinoma12.6
Salivary Gland Carcinoma14.0

Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 4.0 (NCT02538510)
Timeframe: Up to 30 days after the completion of study treatment

,
InterventionParticipants (Count of Participants)
Adrenal insufficiencyALT increaseAnorexiaArthiritisAST increaseCoughIncreased CreatinineDermatitisDiarrheaFever with leukocytosisFatigueHyponatremiaHypothyroidismColitis and IleitisMalaiseNauseaNephritisPneumonitisNeuritisTracheitis/EpiglottitisVomiting
Head and Neck Squamous Cell Carcinoma100001210022111101011
Salivary Gland Carcinoma111110501140000310102

Objective Response Rate

Radiologic assessments of measurable disease will be performed using radiographic imaging. RECIST 1.1 and immune response criteria will be used to assess response to therapy. Responses will be summarized as frequencies and percentages. (NCT02538510)
Timeframe: Up to 2 years

,
InterventionParticipants (Count of Participants)
partial responsestable diseaseprogressive disease
Head and Neck Squamous Cell885
Salivary Gland Carcinoma4136

Objective Tumor Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00363883)
Timeframe: Response assessed after every 2 cycles (6 weeks) up to 26 weeks

Interventionpercentage of patients (Number)
Treatment (Vorinostat)0

Overall Survival

Will be estimated using the product-limit method of Kaplan and Meier. (NCT00363883)
Timeframe: Up to 26 weeks

Interventionmonths (Median)
Treatment (Vorinostat)4.3

Progression-free Survial

Will be estimated using the product-limit method of Kaplan and Meier. Progression defined using RECIST v1.0 criteria, at least a 20% increase in the sum of the longest diameter of target lesions, or the appearance of one or more new lesions. (NCT00363883)
Timeframe: assessed up to 26 weeks

Interventionmonths (Median)
Treatment (Vorinostat)1.1

Number of Participants With Grade 3 or Greater Non-hematologic Toxicities

Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG (NCT02035137)
Timeframe: All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months

InterventionParticipants (Count of Participants)
Single-Agent 131I-MIBG7
131I-MIBG With Vincristine/Irinotecan17
131I-MIBG With Vorinostat12

Objective Tumor Response After One Course of Therapy

To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria > 30% decrease in target tumor size. Curie score was used with PR criteria > 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR. (NCT02035137)
Timeframe: 43-50 days from study day 1

InterventionParticipants (Count of Participants)
Single-Agent 131I-MIBG5
131I-MIBG With Vincristine/Irinotecan5
131I-MIBG With Vorinostat11

Median Overall Survival (OS)

Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival. (NCT01738646)
Timeframe: 3 Years

Interventionmonths (Median)
Vorinostat & Bevacizumab10.4

Median Progression-free Survival (PFS)

Progression-free survival is defined as the time in months from the start of protocol treatment until the date of progression or death if death occurred before progression. If the participant is alive and progression-free, PFS will be censored at the date of last follow-up. Kaplan-Meier methods will be used to estimate progression-free survival. (NCT01738646)
Timeframe: 3 Years

Interventionmonths (Median)
Vorinostat & Bevacizumab3.7

Percentage of Participants Who Experience Grade 3 or Greater, Treatment Related, Non-hematologic Toxicities.

The percentage of participants who experience grade 3 or greater, treatment-related, non-hematologic toxicities will be calculated. (NCT01738646)
Timeframe: 2.7 Years

Interventionpercentage of participants (Number)
Vorinostat & Bevacizumab40

Radiographic Response

The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every second cycle (every 8 weeks) thereafter. (NCT01738646)
Timeframe: 3 Years

Interventionpercentage of participants (Number)
Vorinostat & Bevacizumab22.5

Six-month Progression-free Survival (PFS6)

The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. Based on Response Assessment in Neuro-Oncology (RANO) criteria, progression is defined as a ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of non-measurable disease. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival. (NCT01738646)
Timeframe: 6 months

Interventionpercentage of participants (Number)
Vorinostat & Bevacizumab30

Pruritis Evaluation

"The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life.~LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate." (NCT01728805)
Timeframe: Cycle 1, 3, and 5

Interventionscore on a scale (Least Squares Mean)
KW-0761-0.5
Vorinostat-0.4

Overall Response Rate

The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment. (NCT01728805)
Timeframe: at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months

,
InterventionParticipants (Count of Participants)
All Subjects ORR (confirmed CR + PR)Disease Type = MF ORR (confirmed CR + PR)Disease Type = SS ORR (confirmed CR + PR)
KW-0761522230
Vorinostat972

Progression Free Survival

"Progression was defined as follows, based on Olsen (2011):~Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node > 1.5 cm in the long axis or > 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or > 50% increase from nadir in SPD of lymph nodes in those with PR~Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score~Blood: B0 to B2, > 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or > 50% increase from nadir and at least 5,000 neoplastic cells/μL~Viscera: > 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or > 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR" (NCT01728805)
Timeframe: From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

,
Interventionpercentage of subjects (Number)
Rate (%) of Being Alive w/o Progression at 6 mos.Rate (%) of Being Alive w/o Progression at 12 mos.Rate (%) of Being Alive w/o Progression at 18 mos.Rate (%) of Being Alive w/o Progression at 24 mos.Rate (%) of Being Alive w/o Progression at 30 mos.
KW-076155.338.328.014.14.7
Vorinostat28.815.37.27.27.2

Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score

"Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, & functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease.~FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL.~EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health.~LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate." (NCT01728805)
Timeframe: Cycle 1, 3, and 5

,
Interventionscore on a scale (Least Squares Mean)
Skindex-29 Across 6-month AssessmentFACT-G Across 6-month AssessmentEQ-5D-3L Across 6-month Assessment
KW-0761-12.64.60.06
Vorinostat-6.0-2.30.02

Objective Response Rate

Objective response rate was measured as the proportion of patients who achieved a confirmed partial response or better during the course of the study. Response to study therapy was assessed using EBMT Criteria and confirmed by Independent Adjudication Review. (NCT00773747)
Timeframe: Baseline and at the end of each 21-day Cycle assessed up to 32 months (final study analysis)

InterventionPercentage of Participants (Number)
Vorinostat + Bortezomib56.2
Placebo + Bortezomib40.6

Overall Survival

Overall survival was measured from the start of the treatment to death due to any cause. Overall Survival is represented as the number of deaths per 100-person- months and was computed by dividing the number of participants with an event of death that occurred during the study follow-up period by the total duration of follow-up (in 100 months) for all the participants in each cohort since participants had different lengths of follow-up. (NCT00773747)
Timeframe: From randomization up to 32 months (final study analysis)

InterventionEvents/100-person Months (Number)
Vorinostat + Bortezomib1.7
Placebo + Bortezomib1.9

Progression-Free Survival (PFS)

Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (whichever is first recorded). Response to study therapy was assessed using European Blood and Marrow Transplantation Group (EBMT) Criteria. A stratified Cox proportional hazards model was used with Efron's likelihood approximation to account for ties in event times. (NCT00773747)
Timeframe: From randomization to event of disease progression or death assessed up to 32 months (final study analysis)

InterventionMonths (Median)
Vorinostat + Bortezomib7.63
Placebo + Bortezomib6.83

Time to Progression

Time to progression was measured from the start of the treatment to the time when the criteria for progression was met or death due to myeloma (whichever is first recorded). Response to study therapy was assessed using European Blood and Marrow Transplantation Group (EBMT) Criteria. A stratified Cox proportional hazards model was used with Efron's likelihood approximation to account for ties in event times. (NCT00773747)
Timeframe: Baseline and at the end of each 21-day Cycle assessed up to 32 months (final study analysis)

InterventionMonths (Median)
Vorinostat + Bortezomib7.73
Placebo + Bortezomib7.03

Number of Participants With Grade 3-5 Clinical or Laboratory Adverse Events (AEs)

An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. Grades come from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Per protocol, clinical and laboratory AEs are presented as a combined total for each grade. (NCT00773747)
Timeframe: Up to 722 days

,
InterventionParticipants (Count of Participants)
Grade 3Grade 4Grade 5
Placebo + Bortezomib2408517
Vorinostat + Bortezomib27210811

Objective Response Rate by Independent Radiological Review

Defined as the best overall response (complete or partial response) across all assessment time-points from randomisation to end of trial treatment, determined by RECIST 1.1 criteria. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionpercentage of participants (Number)
Pembrolizumab Arm21.9
Standard Chemotherapy Arm5.6

Overall Survival.

Defined as time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).

Interventionmonths (Median)
Pembrolizumab Arm10.7
Standard Chemotherapy Arm12.4

Progression Free Survival (PFS) as Assessed by Independent Radiological Review

To investigate whether treatment with pembrolizumab improves PFS, compared to standard, institutional choice chemotherapy, assessed according to RECIST 1.1 criteria based on independent radiological review; using Kaplan-Meier method and compared between the two treatment arms by a stratified log rank test. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionmonths (Median)
Pembrolizumab Arm2.5
Standard Chemotherapy Arm3.4

Progression Free Survival (PFS) Assessed by Investigator

Investigator assessed PFS, from the date of randomisation until documented progression or death, if progression is not documented. Censoring occurs at the last tumor assessment. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionmonths (Median)
Pembrolizumab Arm3.5
Standard Chemotherapy Arm3.7

Time to Treatment Failure.

Time from from randomisation to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, refusal and death, by Kaplan Meier method. Censoring will occur at the last follow-up date. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionmonths (Median)
Pembrolizumab Arm2.8
Standard Chemotherapy Arm2.3

Percentage of Patients Experienced AEs/SAEs

The safety and tolerability of pembrolizumab treatment will be assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period. Adverse events are collected from study treatment initiation to 30 days after treatment is ceased for any reason. Serious adverse events and events of clinical interest are collected within 90 days after last dose of trial treatment. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

,
InterventionParticipants (Count of Participants)
Experienced any adverse eventExperienced treatment related adverse eventExperienced treatment related adverse event of grade 3-5Experienced treatment related adverse event leading to deathExperienced treatment related adverse event leading to treatment discontinuation
Pembrolizumab Arm70501415
Standard Chemotherapy Arm65521815

Number of Participants Who Discontinued Study Treatment Due to an AE

An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. The final analysis for participants who discontinued study treatment due to an AE was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who discontinued study treatment due to an AE is reported here for all randomized participants who received ≥1 dose of study treatment. As specified by the protocol, participants who discontinued study treatment due to an AE remained on study until investigator notification to discontinue. (NCT00128102)
Timeframe: Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)

InterventionParticipants (Count of Participants)
Vorinostat60
Placebo49

Number of Participants Who Experienced Adverse Events (AEs) Characterized as Grade 3 or Grade 4 According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. Reporting of AEs per NCI CTCAE is based on 5 grades of severity; Grade 1 (mild; no treatment needed), Grade 2 (moderate; minimal treatment needed), Grade 3 (severe, not life threatening; hospitalization needed), Grade 4 (life threatening; urgent treatment needed) and Grade 5 (death).The final analysis for Grade 3 or 4 AEs was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who experienced Grade 3/4 AEs per NCI CTCAE is reported here for all randomized participants who received ≥1 dose of study treatment. (NCT00128102)
Timeframe: Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)

InterventionParticipants (Count of Participants)
Vorinostat165
Placebo146

Number of Participants Who Experienced an AE

An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. The final analysis for participants who experienced an AE was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol number of participants who experienced an AE is reported here for all randomized participants who received ≥1 dose of study treatment. (NCT00128102)
Timeframe: Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)

InterventionParticipants (Count of Participants)
Vorinostat327
Placebo311

Objective Response Rate (ORR)

ORR was defined as the percentage of participants in the analysis population who had a complete response (CR: disappearance of all target lesions with no evidence of tumor elsewhere) or a partial response (PR: ≥30% reduction in the total tumor measurement) per Meso-modified RECIST based on independent radiology review. Meso-modified RECIST was created and validated for disease measurement in pleural mesothelioma. The final analysis for ORR per Meso-modified RECIST by independent radiology review was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol percentage of participants who had a CR or a PR per Meso-modified RECIST by independent radiology review is reported here as the ORR for all randomized participants who had valid baseline data for ORR analysis available. (NCT00128102)
Timeframe: Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)

InterventionPercentage of Participants (Number)
Vorinostat0.63
Placebo0.31

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of final analysis were censored at the date of the last follow up. The final analysis for OS was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. OS analysis is reported here for all randomized participants. (NCT00128102)
Timeframe: Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)

InterventionWeeks (Median)
Vorinostat30.7
Placebo27.1

Percent Change From Baseline in Forced Vital Capacity (FVC) at Week 12

Pulmonary function test was conducted using a spirometer for assessment of FVC. FVC is the volume of air forcibly exhaled from the lungs after taking the deepest breath possible. Baseline measurement was taken before treatment initiation. Per protocol percent change in FVC from baseline to Week 12 post treatment initiation (percent change calculated: [Week 12 - Baseline]/Baseline*100)] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for FVC available. (NCT00128102)
Timeframe: Baseline, Week 12

InterventionPercent Change (Mean)
Vorinostat-6.0
Placebo-5.6

Percent Change From Baseline in Lung Cancer Symptom Scale, Modified for Mesothelioma (LCSS-Meso) Dyspnea Score at Week 12

LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percent change in the LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation (percent change calculated: [Week 12 - Baseline]/Baseline*100)] is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available. (NCT00128102)
Timeframe: Baseline, Week 12

InterventionPercent Change (Mean)
Vorinostat141.8
Placebo174.7

Percentage of Participants With ≥10% Change From Baseline in FVC at Week 12

Pulmonary function test was conducted using a spirometer for assessment of FVC. FVC is the volume of air forcibly exhaled from the lungs after taking the deepest breath possible. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥10% change (percent change calculated: [Week 12 - Baseline]/Baseline*100) in FVC from baseline to Week 12 post treatment initiation is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for FVC. (NCT00128102)
Timeframe: Baseline, Week 12

InterventionPercentage of participants (Number)
Vorinostat24.76
Placebo21.63

Percentage of Participants With ≥50% Change Together With a >10 mm Change From Baseline in the LCSS-Meso Dyspnea Score at Week 12

LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥50% change (percent change calculated: [Week 12 - Baseline]/Baseline*100) and >10 mm absolute change in LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available. (NCT00128102)
Timeframe: Baseline, Week 12

InterventionPercentage of participants (Number)
Vorinostat15.05
Placebo16.39

Progression Free Survival (PFS)

PFS was defined as the time from randomization to the first documented progressive disease (PD) per meso-modified-Response Evaluation Criteria in Solid Tumors (Meso-modified RECIST) based on independent radiology review or death due to any cause, whichever occurred first. Meso-modified RECIST was created and validated for disease measurement in pleural mesothelioma. Per meso-modified RECIST, PD was defined as ≥20% increase in the total tumor measurement over the nadir measurement or the appearance of ≥1 new lesions. The final analysis for PFS per Meso-modified RECIST by independent radiology review was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. PFS analysis per Meso-modified RECIST by independent radiology review is reported here for all randomized participants. (NCT00128102)
Timeframe: Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)

InterventionWeeks (Median)
Vorinostat6.3
Placebo6.1

Dose Limiting Toxicity (DLT) [Phase Ib]

"Dose-limiting toxicity was based on the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) and defined as any of the following:~Any CTCAE grade 3 or 4 non-hematologic event except manageable gastrointestinal toxicity and fatigue.~Any of the following hematologic events (excluding neutropenia lasting < 5 days):~i) febrile neutropenia defined as grade 3-4 neutropenia with fever ≥ 38.5°C and/or infection.~ii) any grade 4 neutropenia lasting 5 days or more. iii) grade 4 thrombocytopenia (plt count < 25x 109/L) iv) failure of ANC to recover to ≥ 1000/μL or platelets to recover to ≥ 50,000/μL within 14 days of therapy v) grade 4 anemia~Any clinically significant abnormal laboratory value that results in dose delay of >14 days.~<75% of vorinostat dosing taken by the patient during the first cycle due to any toxicity." (NCT00910000)
Timeframe: The DLT observation period in determining the MTD was the 21-day cycle 1 length.

Interventionparticipants with DLT (Number)
Dose Level 1A0
Dose Level 2A2
Dose Level 1B2
Dose Level 1C2
Dose Level 1D0
Dose Level 2D1

Vorinostat Maximum Tolerated Dose (MTD) [Phase Ib]

The Vorinostat MTD is determined by the number of patients who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients experience a DLT. If no DLTs are observed, the MTD is not reached. (NCT00910000)
Timeframe: The DLT observation period in determining the MTD was the 21-day cycle 1 length.

Interventionmg/day (Number)
All Phase Ib ParticipantsNA

Response

Response was based on RECIST 1.0 criteria. Per RECIST 1.0 for target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Progressive disease (PD) is at least a 20% increase in sum LD from the smallest LD recorded on treatment. Stable disease (SD) is neither sufficient increase to qualify as PD nor sufficient shrinkage to qualify for PR. For CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed 4 weeks +/- 2 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Participants who received therapy but did not have their disease re-evaluated were considered unevaluable. (NCT00910000)
Timeframe: Disease was assessed radiographically (CT or MRI scan) every 2 cycles on treatment; Phase Ib participants received up to 8 cycles of treatment. The median number of cycles started was 2 (range 1-8).

,,,,,
Interventionparticipants (Number)
Complete ResponsePartial ResponseStable DiseaseProgressive DiseaseUnevaluable
Dose Level 1A03000
Dose Level 1B00003
Dose Level 1C01001
Dose Level 1D02001
Dose Level 2A00102
Dose Level 2D00001

2-Year Overall Survival

Estimated using the product-limit method of Kaplan and Meier. (NCT00253630)
Timeframe: Until Death from any cause, up to 2 years

Interventionpercentage of participants (Number)
Treatment (Vorinostat)77

2-Year Progression Free-Survival

Estimated using the product-limit method of Kaplan and Meier. Progression defined as any new lesion or increase by greater than 50% of previously involved sites from nadir. (NCT00253630)
Timeframe: Until death or progression, up to 2 years

Interventionpercentage of participants (Number)
Treatment (Vorinostat)37

Response Rate

Radiological assessment by CT and/or PET scan after every three cycles (every 3 months). Response assessed by the standard Cheson criteria (Cheson et al, J Clin Oncol 17:1244, 1999). Complete Remission (CR) - (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT; Partial Remission (PR) - 50% or greater decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes (a) FDG-avid or PET positive prior to therapy; one or more PET positive at previously involved site (b) Variably FDG-avid or PET negative; regression on CT. Response Rate = CR + PR. (NCT00253630)
Timeframe: Up to 3 years

Interventionpercentage of participants (Number)
Treatment (Vorinostat)29

Number of Participants With Adverse Events

Grades 3 & 4 adverse events definitely, probably or possibly related to treatment, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. (NCT00253630)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
ANCAnorexiaFatigueHemoglobinHypokalemiaHyponatremiaHypophosphatemiaInfection -Skin (cellulitis)INRLeukocytes (total WBC)LymphopeniaMyalgiaMucositis/stomatitisPlateletsThrombosis/thrombus/embolism
Treatment (Vorinostat)6134112124511102

Reviews

2 reviews available for vorinostat and Local Neoplasm Recurrence

ArticleYear
Role of Histone Deacetylase Inhibitors in Relapsed Refractory Multiple Myeloma: A Focus on Vorinostat and Panobinostat.
    Pharmacotherapy, 2015, Volume: 35, Issue:12

    Topics: Antineoplastic Agents; Histone Deacetylase Inhibitors; Humans; Hydroxamic Acids; Indoles; Multiple M

2015
Histone deacetylase inhibitors in lymphoma and solid malignancies.
    Expert review of anticancer therapy, 2008, Volume: 8, Issue:3

    Topics: Animals; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Benzamides; Depsipep

2008

Trials

31 trials available for vorinostat and Local Neoplasm Recurrence

ArticleYear
Real-world experience in treating pediatric relapsed/refractory or therapy-related myeloid malignancies with decitabine, vorinostat, and FLAG therapy based on a phase 1 study run by the TACL consortium.
    Pediatric blood & cancer, 2022, Volume: 69, Issue:10

    Topics: Antineoplastic Combined Chemotherapy Protocols; Child; Cytarabine; Decitabine; Granulocyte Colony-St

2022
Neutrophil to lymphocyte ratio and peripheral blood biomarkers correlate with survival outcomes but not response among head and neck and salivary cancer treated with pembrolizumab and vorinostat.
    Head & neck, 2023, Volume: 45, Issue:2

    Topics: Biomarkers; Head and Neck Neoplasms; Humans; Lymphocytes; Neoplasm Recurrence, Local; Neutrophils; P

2023
Neutrophil to lymphocyte ratio and peripheral blood biomarkers correlate with survival outcomes but not response among head and neck and salivary cancer treated with pembrolizumab and vorinostat.
    Head & neck, 2023, Volume: 45, Issue:2

    Topics: Biomarkers; Head and Neck Neoplasms; Humans; Lymphocytes; Neoplasm Recurrence, Local; Neutrophils; P

2023
Neutrophil to lymphocyte ratio and peripheral blood biomarkers correlate with survival outcomes but not response among head and neck and salivary cancer treated with pembrolizumab and vorinostat.
    Head & neck, 2023, Volume: 45, Issue:2

    Topics: Biomarkers; Head and Neck Neoplasms; Humans; Lymphocytes; Neoplasm Recurrence, Local; Neutrophils; P

2023
Neutrophil to lymphocyte ratio and peripheral blood biomarkers correlate with survival outcomes but not response among head and neck and salivary cancer treated with pembrolizumab and vorinostat.
    Head & neck, 2023, Volume: 45, Issue:2

    Topics: Biomarkers; Head and Neck Neoplasms; Humans; Lymphocytes; Neoplasm Recurrence, Local; Neutrophils; P

2023
Neutrophil to lymphocyte ratio and peripheral blood biomarkers correlate with survival outcomes but not response among head and neck and salivary cancer treated with pembrolizumab and vorinostat.
    Head & neck, 2023, Volume: 45, Issue:2

    Topics: Biomarkers; Head and Neck Neoplasms; Humans; Lymphocytes; Neoplasm Recurrence, Local; Neutrophils; P

2023
Neutrophil to lymphocyte ratio and peripheral blood biomarkers correlate with survival outcomes but not response among head and neck and salivary cancer treated with pembrolizumab and vorinostat.
    Head & neck, 2023, Volume: 45, Issue:2

    Topics: Biomarkers; Head and Neck Neoplasms; Humans; Lymphocytes; Neoplasm Recurrence, Local; Neutrophils; P

2023
Neutrophil to lymphocyte ratio and peripheral blood biomarkers correlate with survival outcomes but not response among head and neck and salivary cancer treated with pembrolizumab and vorinostat.
    Head & neck, 2023, Volume: 45, Issue:2

    Topics: Biomarkers; Head and Neck Neoplasms; Humans; Lymphocytes; Neoplasm Recurrence, Local; Neutrophils; P

2023
Neutrophil to lymphocyte ratio and peripheral blood biomarkers correlate with survival outcomes but not response among head and neck and salivary cancer treated with pembrolizumab and vorinostat.
    Head & neck, 2023, Volume: 45, Issue:2

    Topics: Biomarkers; Head and Neck Neoplasms; Humans; Lymphocytes; Neoplasm Recurrence, Local; Neutrophils; P

2023
Neutrophil to lymphocyte ratio and peripheral blood biomarkers correlate with survival outcomes but not response among head and neck and salivary cancer treated with pembrolizumab and vorinostat.
    Head & neck, 2023, Volume: 45, Issue:2

    Topics: Biomarkers; Head and Neck Neoplasms; Humans; Lymphocytes; Neoplasm Recurrence, Local; Neutrophils; P

2023
Phase 1 study of the Aurora kinase A inhibitor alisertib (MLN8237) combined with the histone deacetylase inhibitor vorinostat in lymphoid malignancies.
    Leukemia & lymphoma, 2020, Volume: 61, Issue:2

    Topics: Aurora Kinase A; Azepines; Histone Deacetylase Inhibitors; Humans; Lymphoproliferative Disorders; Ne

2020
A Phase II Trial of Pembrolizumab and Vorinostat in Recurrent Metastatic Head and Neck Squamous Cell Carcinomas and Salivary Gland Cancer.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2020, 02-15, Volume: 26, Issue:4

    Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemother

2020
A Bayesian adaptive randomized phase II multicenter trial of bevacizumab with or without vorinostat in adults with recurrent glioblastoma.
    Neuro-oncology, 2020, 10-14, Volume: 22, Issue:10

    Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Bayes Theorem; Bevacizumab; Brain Neoplasms;

2020
Durable Complete Response to AMG 655 (Conatumumab) and Vorinostat in a Patient With Relapsed Classical Hodgkin Lymphoma: Extraordinary Response from a Phase 1b Clinical Protocol.
    Clinical lymphoma, myeloma & leukemia, 2020, Volume: 20, Issue:12

    Topics: Adult; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Hodgkin Disease; Huma

2020
Phase II study of the histone deacetylase inhibitor vorinostat (Suberoylanilide Hydroxamic Acid; SAHA) in recurrent or metastatic transitional cell carcinoma of the urothelium - an NCI-CTEP sponsored: California Cancer Consortium trial, NCI 6879.
    Investigational new drugs, 2021, Volume: 39, Issue:3

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma, Transitional Cell; Female; Histone

2021
Randomized Phase II Trial of MIBG Versus MIBG, Vincristine, and Irinotecan Versus MIBG and Vorinostat for Patients With Relapsed or Refractory Neuroblastoma: A Report From NANT Consortium.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021, 11-01, Volume: 39, Issue:31

    Topics: 3-Iodobenzylguanidine; Adolescent; Adult; Antineoplastic Combined Chemotherapy Protocols; Child; Chi

2021
A phase 2 study of vorinostat in locally advanced, recurrent, or metastatic adenoid cystic carcinoma.
    Oncotarget, 2017, May-16, Volume: 8, Issue:20

    Topics: Adult; Aged; Carcinoma, Adenoid Cystic; Chromatin Assembly and Disassembly; Exome Sequencing; Female

2017
A Phase I/II study of suberoylanilide hydroxamic acid (SAHA) in combination with trastuzumab (Herceptin) in patients with advanced metastatic and/or local chest wall recurrent HER2-amplified breast cancer: a trial of the ECOG-ACRIN Cancer Research Group (
    Breast cancer research and treatment, 2017, Volume: 165, Issue:2

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Breast Neoplasms; Co

2017
Final Results of a Phase 1 Study of Vorinostat, Pegylated Liposomal Doxorubicin, and Bortezomib in Relapsed or Refractory Multiple Myeloma.
    Clinical lymphoma, myeloma & leukemia, 2017, Volume: 17, Issue:7

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Doxorubicin; Drug Resistanc

2017
Phase II Study of Bevacizumab and Vorinostat for Patients with Recurrent World Health Organization Grade 4 Malignant Glioma.
    The oncologist, 2018, Volume: 23, Issue:2

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Brain Neoplasms; Female; F

2018
Phase I/II trial of vorinostat, bevacizumab, and daily temozolomide for recurrent malignant gliomas.
    Journal of neuro-oncology, 2018, Volume: 137, Issue:2

    Topics: Adult; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Bevacizumab; Brain Neo

2018
Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial.
    The Lancet. Oncology, 2018, Volume: 19, Issue:9

    Topics: Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Immunological; Australia; Drug Admin

2018
Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial.
    The Lancet. Oncology, 2018, Volume: 19, Issue:9

    Topics: Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Immunological; Australia; Drug Admin

2018
Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial.
    The Lancet. Oncology, 2018, Volume: 19, Issue:9

    Topics: Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Immunological; Australia; Drug Admin

2018
Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial.
    The Lancet. Oncology, 2018, Volume: 19, Issue:9

    Topics: Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Agents, Immunological; Australia; Drug Admin

2018
A Phase II Trial of Bortezomib and Vorinostat in Mantle Cell Lymphoma and Diffuse Large B-cell Lymphoma.
    Clinical lymphoma, myeloma & leukemia, 2018, Volume: 18, Issue:9

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Bortezomib; Drug Res

2018
FDA Approval Summary: Mogamulizumab-kpkc for Mycosis Fungoides and Sézary Syndrome.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2019, 12-15, Volume: 25, Issue:24

    Topics: Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Drug Approval; Drug Resistance, N

2019
Vorinostat or placebo in combination with bortezomib in patients with multiple myeloma (VANTAGE 088): a multicentre, randomised, double-blind study.
    The Lancet. Oncology, 2013, Volume: 14, Issue:11

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Boronic Acids; Borte

2013
Phase I Study of Vorinostat as a Radiation Sensitizer with 131I-Metaiodobenzylguanidine (131I-MIBG) for Patients with Relapsed or Refractory Neuroblastoma.
    Clinical cancer research : an official journal of the American Association for Cancer Research, 2015, Jun-15, Volume: 21, Issue:12

    Topics: 3-Iodobenzylguanidine; Acetylation; Adolescent; Adult; Aged; Child; Child, Preschool; Drug Monitorin

2015
Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial.
    The Lancet. Oncology, 2015, Volume: 16, Issue:4

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Double-Blind Method;

2015
Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial.
    The Lancet. Oncology, 2015, Volume: 16, Issue:4

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Double-Blind Method;

2015
Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial.
    The Lancet. Oncology, 2015, Volume: 16, Issue:4

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Double-Blind Method;

2015
Vorinostat in patients with advanced malignant pleural mesothelioma who have progressed on previous chemotherapy (VANTAGE-014): a phase 3, double-blind, randomised, placebo-controlled trial.
    The Lancet. Oncology, 2015, Volume: 16, Issue:4

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Double-Blind Method;

2015
Phase I study of combination of vorinostat, carboplatin, and gemcitabine in women with recurrent, platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer.
    Cancer chemotherapy and pharmacology, 2015, Volume: 76, Issue:2

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Carboplatin; Deoxycytidine; Fallopian T

2015
Phase 1 trial of carfilzomib (PR-171) in combination with vorinostat (SAHA) in patients with relapsed or refractory B-cell lymphomas.
    Leukemia & lymphoma, 2016, Volume: 57, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Biomarkers; Combined Modality Therapy;

2016
Phase II trial of vorinostat in recurrent glioblastoma multiforme: a north central cancer treatment group study.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2009, Apr-20, Volume: 27, Issue:12

    Topics: Acetylation; Adult; Aged; Antineoplastic Agents; Brain Neoplasms; Cyclin-Dependent Kinase Inhibitor

2009
Vorinostat (NSC# 701852) in patients with relapsed non-small cell lung cancer: a Wisconsin Oncology Network phase II study.
    Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2009, Volume: 4, Issue:4

    Topics: Aged; Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung; Enzyme Inhibitors; Female; Histone Deac

2009
Phase I study of vorinostat (suberoylanilide hydroxamic acid, NSC 701852) in combination with docetaxel in patients with advanced and relapsed solid malignancies.
    Investigational new drugs, 2012, Volume: 30, Issue:1

    Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Carcinoma, Non-Small-Cell Lung; Docetaxel; Dru

2012
Phase II study of vorinostat for treatment of relapsed or refractory indolent non-Hodgkin's lymphoma and mantle cell lymphoma.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2011, Mar-20, Volume: 29, Issue:9

    Topics: Administration, Oral; Adult; Aged; Antineoplastic Agents; Drug Resistance, Neoplasm; Female; Humans;

2011
A phase 2 study of vorinostat for treatment of relapsed or refractory Hodgkin lymphoma: Southwest Oncology Group Study S0517.
    Leukemia & lymphoma, 2012, Volume: 53, Issue:2

    Topics: Administration, Oral; Adult; Aged; Antineoplastic Agents; Drug Resistance, Neoplasm; Female; Follow-

2012
Phase I trial of vorinostat combined with bevacizumab and CPT-11 in recurrent glioblastoma.
    Neuro-oncology, 2012, Volume: 14, Issue:1

    Topics: Adult; Aged; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Beva

2012
Phase I/II intra-patient dose escalation study of vorinostat in children with relapsed solid tumor, lymphoma or leukemia.
    Klinische Padiatrie, 2012, Volume: 224, Issue:6

    Topics: Administration, Oral; Adolescent; Antineoplastic Agents; Child; Child, Preschool; Dose-Response Rela

2012
Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2005, Jun-10, Volume: 23, Issue:17

    Topics: Administration, Oral; Adult; Aged; Biological Availability; Drug Administration Schedule; Enzyme Inh

2005
Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2005, Jun-10, Volume: 23, Issue:17

    Topics: Administration, Oral; Adult; Aged; Biological Availability; Drug Administration Schedule; Enzyme Inh

2005
Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2005, Jun-10, Volume: 23, Issue:17

    Topics: Administration, Oral; Adult; Aged; Biological Availability; Drug Administration Schedule; Enzyme Inh

2005
Phase I study of an oral histone deacetylase inhibitor, suberoylanilide hydroxamic acid, in patients with advanced cancer.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2005, Jun-10, Volume: 23, Issue:17

    Topics: Administration, Oral; Adult; Aged; Biological Availability; Drug Administration Schedule; Enzyme Inh

2005
Phase II trial of the histone deacetylase inhibitor vorinostat (Zolinza, suberoylanilide hydroxamic acid, SAHA) in patients with recurrent and/or metastatic head and neck cancer.
    Investigational new drugs, 2008, Volume: 26, Issue:1

    Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Anorexia; Antineoplastic Agents; Capsules; Car

2008
A phase II study of vorinostat in the treatment of persistent or recurrent epithelial ovarian or primary peritoneal carcinoma: a Gynecologic Oncology Group study.
    Gynecologic oncology, 2008, Volume: 109, Issue:2

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Carcinoma; Disease-Free Survival; Female; Gas

2008

Other Studies

8 other studies available for vorinostat and Local Neoplasm Recurrence

ArticleYear
An Injectable Epigenetic Autophagic Modulatory Hydrogel for Boosting Umbilical Cord Blood NK Cell Therapy Prevents Postsurgical Relapse of Triple-Negative Breast Cancer.
    Advanced science (Weinheim, Baden-Wurttemberg, Germany), 2022, Volume: 9, Issue:23

    Topics: Autophagy; Cell- and Tissue-Based Therapy; Epigenesis, Genetic; Fetal Blood; Humans; Hydrogels; Neop

2022
Combined epigenetic and immunotherapy for blastic and classical mantle cell lymphoma.
    Oncotarget, 2022, Volume: 13

    Topics: Adult; Antigens, CD20; Cladribine; Epigenesis, Genetic; Humans; Immunologic Factors; Immunotherapy;

2022
High-Dose Chemotherapy and Autologous Stem Cell Transplantation for Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma.
    Transplantation and cellular therapy, 2023, Volume: 29, Issue:11

    Topics: Adult; Antineoplastic Combined Chemotherapy Protocols; Hematopoietic Stem Cell Transplantation; Huma

2023
MDM2 Degrades Deacetylated Nucleolin Through Ubiquitination to Promote Glioma Stem-Like Cell Enrichment for Chemotherapeutic Resistance.
    Molecular neurobiology, 2018, Volume: 55, Issue:4

    Topics: Acetylation; Brain Neoplasms; Cell Line, Tumor; Down-Regulation; Drug Resistance, Neoplasm; Gene Exp

2018
The blueberry component pterostilbene has potent anti-myeloma activity in bortezomib-resistant cells.
    Oncology reports, 2017, Volume: 38, Issue:1

    Topics: Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Apoptosis; Blueberry Plants;

2017
Development of a Novel Histone Deacetylase-Targeted Near-Infrared Probe for Hepatocellular Carcinoma Imaging and Fluorescence Image-Guided Surgery.
    Molecular imaging and biology, 2020, Volume: 22, Issue:3

    Topics: Animals; Apoptosis; Benzenesulfonates; Carcinoma, Hepatocellular; Cell Line, Tumor; Cell Proliferati

2020
Vorinostat for refractory or relapsing epidermotropic T-cell lymphoma: a retrospective cohort study of 15 patients.
    Acta dermato-venereologica, 2015, Volume: 95, Issue:1

    Topics: Adult; Aged; Antineoplastic Agents; Disease Progression; Drug Resistance, Neoplasm; Female; Histone

2015
Double epigenetic modulation of high-dose chemotherapy with azacitidine and vorinostat for patients with refractory or poor-risk relapsed lymphoma.
    Cancer, 2016, 09-01, Volume: 122, Issue:17

    Topics: Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Azacitidine; Busulfan; Chil

2016