temozolomide and Neutropenia studies

Research Excerpts

Excerpt	Relevance	Reference
" We performed a phase I study to determine the maximum tolerated dose and preliminary efficacy of pegylated nanoliposomal irinotecan (nal-IRI)+metronomic temozolomide (TMZ) in patients with recurrent glioblastoma."	9.41	Nanoliposomal Irinotecan and Metronomic Temozolomide for Patients With Recurrent Glioblastoma: BrUOG329, A Phase I Brown University Oncology Research Group Trial. ( Baekey, J; Carcieri, A; Cielo, D; Disano, D; Donnelly, J; Elinzano, H; MacKinnon, K; Mohler, A; Robison, J; Safran, H; Sturtevant, A; Toms, S; Vatketich, J; Wood, R, 2021)
"In a search for more effective combination chemotherapy for the treatment of metastatic melanoma, we conducted a phase I trial of a novel combination of docetaxel, temozolomide, and cisplatin."	9.14	Phase I study of the combination of docetaxel, temozolomide and cisplatin in patients with metastatic melanoma. ( Bedikian, AY; Camacho, LH; Frost, AM; Hernandez, IM; Hwu, P; Hwu, WJ; Jack, MA; Kim, KB; Ng, C; Papadopoulos, NE, 2009)
"Temozolomide is an alkylating agent with activity in the treatment of melanoma metastatic to the brain."	9.12	A phase I/II study of lomustine and temozolomide in patients with cerebral metastases from malignant melanoma. ( Bate, SC; Beirne, DA; Eisen, TG; Gibbens, IM; Gore, ME; Hughes, SA; Larkin, JM; Patel, PM; Thomas, K, 2007)
"The objective of the study was to evaluate the efficacy and toxicity of Temozolomide (TMZ) administered for 5 consecutive days in three daily dosing in children with recurrent or refractory high-grade glioma."	9.12	Phase II trial of temozolomide in children with recurrent high-grade glioma. ( Abate, ME; Attinà, G; Caldarelli, M; Cefalo, G; Clerico, A; Colosimo, C; Di Rocco, C; Garré, ML; Lazzareschi, I; Madon, E; Massimino, M; Maurizi, P; Mazzarella, G; Riccardi, R; Ridola, V; Ruggiero, A; Sandri, A, 2006)
"Temozolomide, a DNA methylating agent used to treat melanoma, induces DNA damage, which is repaired by O6-alkylguanine alkyltransferase (ATase) and poly(ADP-ribose) polymerase-1 (PARP-1)-dependent base excision repair."	9.11	Temozolomide pharmacodynamics in patients with metastatic melanoma: dna damage and activity of repair enzymes O6-alkylguanine alkyltransferase and poly(ADP-ribose) polymerase-1. ( Boddy, AV; Calvert, AH; Curtin, NJ; Harris, AL; Hickson, I; Jones, C; Margison, GP; McGown, G; McHugh, P; Middleton, MR; Newell, DR; Olsen, A; Plummer, ER; Thorncroft, M; Watson, AJ, 2005)
"The combination of temozolomide and docetaxel was effective and well tolerated as first-line treatment for patients with advanced metastatic melanoma and demonstrated encouraging antitumor activity against brain metastases."	9.10	Temozolomide in combination with docetaxel in patients with advanced melanoma: a phase II study of the Hellenic Cooperative Oncology Group. ( Bafaloukos, D; Briassoulis, E; Fountzilas, G; Georgoulias, V; Gogas, H; Kalofonos, Ch; Karabelis, A; Kosmidis, P; Samantas, E; Skarlos, D, 2002)
"Irinotecan plus temozolomide combination chemotherapy showed antitumor activity and an acceptable safety profile in patients with relapsed Ewing sarcoma."	8.12	Irinotecan plus temozolomide in relapsed Ewing sarcoma: an integrated analysis of retrospective studies. ( Lin, GH; Wang, BC; Xiao, BY, 2022)
"Standard treatment for patients with primary glioblastoma (GBM) includes surgery, radiotherapy, and concomitant and adjuvant temozolomide (TMZ)."	7.88	Prognostic importance of temozolomide-induced neutropenia in glioblastoma, IDH-wildtype patients. ( Hama, S; Kawamata, T; Kurisu, K; Muragaki, Y; Nosaka, R; Saito, T; Sugiyama, K; Takayasu, T; Yamasaki, F, 2018)
"To report a retrospective data on the efficacy and safety of capecitabine and temozolomide (CAPTEM regimen) in patients with metastatic pancreatic neuroendocrine tumors (pNETs) who have failed prior therapies."	7.79	A retrospective study of capecitabine/temozolomide (CAPTEM) regimen in the treatment of metastatic pancreatic neuroendocrine tumors (pNETs) after failing previous therapy. ( Brennan, M; Garcon, MC; Kaley, K; Rodriguez, G; Rodriguez, T; Saif, MW, 2013)
"Glioblastoma is the most common and most aggressive type of primary brain tumor."	7.30	Granulocyte-macrophage colony stimulating factor enhances efficacy of nimustine rendezvousing with temozolomide plus irradiation in patients with glioblastoma. ( Bu, XY; Cheng, X; Kong, LF; Luo, JC; Qu, MQ; Wang, YW; Yan, ZY; Yang, DY; Zhao, YW, 2023)
"Seventy-one eligible patients 70 years of age or older with newly diagnosed GBM and a Karnofsky performance status ≥60 were treated with a short course of RT (40 Gy in 15 fractions over 3 weeks) plus TMZ at the dosage of 75 mg/m(2) per day followed by 12 cycles of adjuvant TMZ (150-200 mg/m(2) for 5 days during each 28-day cycle)."	6.77	Phase II study of short-course radiotherapy plus concomitant and adjuvant temozolomide in elderly patients with glioblastoma. ( Arcella, A; Caporello, P; De Sanctis, V; Enrici, RM; Giangaspero, F; Lanzetta, G; Minniti, G; Salvati, M; Scaringi, C, 2012)
"Lomeguatrib, an O(6)-methylguanine-DNA methyltransferase inactivator, was evaluated in an extended dosing regimen with temozolomide, designed according to pharmacodynamic data from previous studies."	6.74	A phase I study of extended dosing with lomeguatrib with temozolomide in patients with advanced melanoma. ( Abdi, E; Beith, J; Corrie, PG; Kefford, RF; Kotasek, D; Margison, GP; Middleton, MR; Mortimer, P; Palmer, C; Ranson, M; Thomas, NP; Watson, AJ, 2009)
"The prognosis for recurrent/progressive Ewing sarcoma (ES) remains poor."	6.74	Irinotecan and temozolomide for Ewing sarcoma: the Memorial Sloan-Kettering experience. ( Casey, DA; Chou, AJ; Merchant, MS; Merola, PR; Meyers, PA; Price, AP; Wexler, LH, 2009)
" Therefore, the authors initiated a Phase I study to determine the pharmacokinetics and safety profile of temozolomide (TMZ), a novel oral alkylating agent known to cross the blood-brain barrier, in combination with interferon alpha-2b (IFN-alpha2b)."	6.71	Temozolomide in combination with interferon alpha-2b in patients with metastatic melanoma: a phase I dose-escalation study. ( Agarwala, SS; Kirkwood, JM, 2003)
"There is no standard treatment for glioblastoma with elements of PNET (GBM-PNET)."	5.43	Craniospinal irradiation with concomitant and adjuvant temozolomide--a feasibility assessment of toxicity in patients with glioblastoma with a PNET component. ( Fersht, N; Mandeville, HC; Mycroft, J; O'Leary, B; Saran, F; Solda, F; Vaidya, S; Zacharoulis, S, 2016)
" We performed a phase I study to determine the maximum tolerated dose and preliminary efficacy of pegylated nanoliposomal irinotecan (nal-IRI)+metronomic temozolomide (TMZ) in patients with recurrent glioblastoma."	5.41	Nanoliposomal Irinotecan and Metronomic Temozolomide for Patients With Recurrent Glioblastoma: BrUOG329, A Phase I Brown University Oncology Research Group Trial. ( Baekey, J; Carcieri, A; Cielo, D; Disano, D; Donnelly, J; Elinzano, H; MacKinnon, K; Mohler, A; Robison, J; Safran, H; Sturtevant, A; Toms, S; Vatketich, J; Wood, R, 2021)
"Cabozantinib inhibits mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2) and has demonstrated activity in patients with recurrent glioblastoma, warranting evaluation of the addition of cabozantinib to radiotherapy (RT) and temozolomide (TMZ) for patients with newly diagnosed high-grade glioma."	5.22	Phase 1 dose escalation trial of the safety and pharmacokinetics of cabozantinib concurrent with temozolomide and radiotherapy or temozolomide after radiotherapy in newly diagnosed patients with high-grade gliomas. ( Chamberlain, MC; Cloughesy, T; Desjardins, A; Glantz, M; Mikkelsen, T; Reardon, DA; Schiff, D; Wen, PY, 2016)
"In a search for more effective combination chemotherapy for the treatment of metastatic melanoma, we conducted a phase I trial of a novel combination of docetaxel, temozolomide, and cisplatin."	5.14	Phase I study of the combination of docetaxel, temozolomide and cisplatin in patients with metastatic melanoma. ( Bedikian, AY; Camacho, LH; Frost, AM; Hernandez, IM; Hwu, P; Hwu, WJ; Jack, MA; Kim, KB; Ng, C; Papadopoulos, NE, 2009)
"Temozolomide (TMZ) is an oral alkylating agent principally indicated for neurological malignancies including glioblastoma (GBM) and astrocytoma."	5.12	Temozolomide-induced aplastic anaemia: Case report and review of the literature. ( Gilbar, PJ; Mangos, HM; Pokharel, K, 2021)
"Temozolomide is an alkylating agent with activity in the treatment of melanoma metastatic to the brain."	5.12	A phase I/II study of lomustine and temozolomide in patients with cerebral metastases from malignant melanoma. ( Bate, SC; Beirne, DA; Eisen, TG; Gibbens, IM; Gore, ME; Hughes, SA; Larkin, JM; Patel, PM; Thomas, K, 2007)
"The objective of the study was to evaluate the efficacy and toxicity of Temozolomide (TMZ) administered for 5 consecutive days in three daily dosing in children with recurrent or refractory high-grade glioma."	5.12	Phase II trial of temozolomide in children with recurrent high-grade glioma. ( Abate, ME; Attinà, G; Caldarelli, M; Cefalo, G; Clerico, A; Colosimo, C; Di Rocco, C; Garré, ML; Lazzareschi, I; Madon, E; Massimino, M; Maurizi, P; Mazzarella, G; Riccardi, R; Ridola, V; Ruggiero, A; Sandri, A, 2006)
"Temozolomide, a DNA methylating agent used to treat melanoma, induces DNA damage, which is repaired by O6-alkylguanine alkyltransferase (ATase) and poly(ADP-ribose) polymerase-1 (PARP-1)-dependent base excision repair."	5.11	Temozolomide pharmacodynamics in patients with metastatic melanoma: dna damage and activity of repair enzymes O6-alkylguanine alkyltransferase and poly(ADP-ribose) polymerase-1. ( Boddy, AV; Calvert, AH; Curtin, NJ; Harris, AL; Hickson, I; Jones, C; Margison, GP; McGown, G; McHugh, P; Middleton, MR; Newell, DR; Olsen, A; Plummer, ER; Thorncroft, M; Watson, AJ, 2005)
"The combination of temozolomide and docetaxel was effective and well tolerated as first-line treatment for patients with advanced metastatic melanoma and demonstrated encouraging antitumor activity against brain metastases."	5.10	Temozolomide in combination with docetaxel in patients with advanced melanoma: a phase II study of the Hellenic Cooperative Oncology Group. ( Bafaloukos, D; Briassoulis, E; Fountzilas, G; Georgoulias, V; Gogas, H; Kalofonos, Ch; Karabelis, A; Kosmidis, P; Samantas, E; Skarlos, D, 2002)
"Irinotecan plus temozolomide combination chemotherapy showed antitumor activity and an acceptable safety profile in patients with relapsed Ewing sarcoma."	4.12	Irinotecan plus temozolomide in relapsed Ewing sarcoma: an integrated analysis of retrospective studies. ( Lin, GH; Wang, BC; Xiao, BY, 2022)
"Standard treatment for patients with primary glioblastoma (GBM) includes surgery, radiotherapy, and concomitant and adjuvant temozolomide (TMZ)."	3.88	Prognostic importance of temozolomide-induced neutropenia in glioblastoma, IDH-wildtype patients. ( Hama, S; Kawamata, T; Kurisu, K; Muragaki, Y; Nosaka, R; Saito, T; Sugiyama, K; Takayasu, T; Yamasaki, F, 2018)
"To report a retrospective data on the efficacy and safety of capecitabine and temozolomide (CAPTEM regimen) in patients with metastatic pancreatic neuroendocrine tumors (pNETs) who have failed prior therapies."	3.79	A retrospective study of capecitabine/temozolomide (CAPTEM) regimen in the treatment of metastatic pancreatic neuroendocrine tumors (pNETs) after failing previous therapy. ( Brennan, M; Garcon, MC; Kaley, K; Rodriguez, G; Rodriguez, T; Saif, MW, 2013)
"Two patients, a 58-year-old man and a 55-year-old woman, both under treatment for glioblastoma multiforme, were admitted with fever and neutropenia a few weeks after starting to take the oncolytic agent temozolomide."	3.74	[Temozolomide, an oral chemotherapeutic agent with potential severe toxicity]. ( Gijtenbeek, JM; Kappelle, AC; Soetekouw, PM; van der Maazen, RW; van Herpen, CM, 2007)
"Glioblastoma is the most common and most aggressive type of primary brain tumor."	3.30	Granulocyte-macrophage colony stimulating factor enhances efficacy of nimustine rendezvousing with temozolomide plus irradiation in patients with glioblastoma. ( Bu, XY; Cheng, X; Kong, LF; Luo, JC; Qu, MQ; Wang, YW; Yan, ZY; Yang, DY; Zhao, YW, 2023)
" There was no clear relationship between vorinostat dosage and drug exposure over the dose range studied."	2.78	A pediatric phase 1 trial of vorinostat and temozolomide in relapsed or refractory primary brain or spinal cord tumors: a Children's Oncology Group phase 1 consortium study. ( Ahern, C; Ames, MM; Blaney, SM; Fouladi, M; Gilbertson, RJ; Horton, T; Hummel, TR; Ingle, AM; McGovern, RM; Reid, JM; Wagner, L; Weigel, B, 2013)
"Seventy-one eligible patients 70 years of age or older with newly diagnosed GBM and a Karnofsky performance status ≥60 were treated with a short course of RT (40 Gy in 15 fractions over 3 weeks) plus TMZ at the dosage of 75 mg/m(2) per day followed by 12 cycles of adjuvant TMZ (150-200 mg/m(2) for 5 days during each 28-day cycle)."	2.77	Phase II study of short-course radiotherapy plus concomitant and adjuvant temozolomide in elderly patients with glioblastoma. ( Arcella, A; Caporello, P; De Sanctis, V; Enrici, RM; Giangaspero, F; Lanzetta, G; Minniti, G; Salvati, M; Scaringi, C, 2012)
"The prognosis for recurrent/progressive Ewing sarcoma (ES) remains poor."	2.74	Irinotecan and temozolomide for Ewing sarcoma: the Memorial Sloan-Kettering experience. ( Casey, DA; Chou, AJ; Merchant, MS; Merola, PR; Meyers, PA; Price, AP; Wexler, LH, 2009)
"Lomeguatrib, an O(6)-methylguanine-DNA methyltransferase inactivator, was evaluated in an extended dosing regimen with temozolomide, designed according to pharmacodynamic data from previous studies."	2.74	A phase I study of extended dosing with lomeguatrib with temozolomide in patients with advanced melanoma. ( Abdi, E; Beith, J; Corrie, PG; Kefford, RF; Kotasek, D; Margison, GP; Middleton, MR; Mortimer, P; Palmer, C; Ranson, M; Thomas, NP; Watson, AJ, 2009)
"Temozolomide (TMZ) has shown modest efficacy in the treatment of recurrent brain metastasis (BM)."	2.72	Vinorelbine combined with a protracted course of temozolomide for recurrent brain metastases: a phase I trial. ( Abrey, LE; Demopoulos, A; Malkin, MG; Omuro, AM; Raizer, JJ, 2006)
" Therefore, the authors initiated a Phase I study to determine the pharmacokinetics and safety profile of temozolomide (TMZ), a novel oral alkylating agent known to cross the blood-brain barrier, in combination with interferon alpha-2b (IFN-alpha2b)."	2.71	Temozolomide in combination with interferon alpha-2b in patients with metastatic melanoma: a phase I dose-escalation study. ( Agarwala, SS; Kirkwood, JM, 2003)
"To characterize and compare pharmacokinetic parameters in children and adults treated with temozolomide (TMZ) administered for 5 days in three doses daily, and to evaluate the possible relationship between AUC values and hematologic toxicity."	2.71	Pharmacokinetics of temozolomide given three times a day in pediatric and adult patients. ( Barone, C; Caldarelli, M; Cefalo, G; Garrè, ML; Lazzareschi, I; Madon, E; Maira, G; Massimino, M; Mastrangelo, S; Mazzarella, G; Riccardi, A; Riccardi, R; Ridola, V; Ruggiero, A; Sandri, A, 2003)
"University-affiliated cancer center."	2.71	Temozolomide in patients with advanced cancer: phase I and pharmacokinetic study. ( Baker, SD; Batra, VK; Cutler, DL; Donehower, RC; Rudek, MA; Statkevich, P, 2004)
"Temozolomide (Temodal) is an oral imidazotetrazine."	2.71	Prolonged schedule of temozolomide (Temodal) plus liposomal doxorubicin (Caelyx) in advanced solid cancers. ( Awada, A; de Valeriola, D; Dubuisson, M; Gil, T; Klastersky, J; Moerman, C; Piccart, MJ; Sales, F; Vereecken, P, 2004)
" In this study, we evaluated the relation between TMZ dosing and AGT depletion in patients with deep visceral tumors and in peripheral blood mononuclear cells (PBMCs) to determine whether the dose of TMZ was sufficient to inactivate AGT and lead to therapeutic efficacy."	2.70	Temozolomide: the effect of once- and twice-a-day dosing on tumor tissue levels of the DNA repair protein O(6)-alkylguanine-DNA-alkyltransferase. ( Gerson, SL; Haaga, J; Liu, L; Majka, S; Spiro, TP; Willson, JK, 2001)
" Plasma samples were obtained on days 1 and 2 to evaluate the pharmacokinetic parameters of TMZ alone and in combination with CDDP."	2.69	A Phase I and pharmacokinetic study of temozolomide and cisplatin in patients with advanced solid malignancies. ( Agarwala, SS; Baker, SD; Barrington, R; Britten, CD; Diab, SG; Eckardt, JR; Eckhardt, SG; Fraass, U; Hammond, LA; Johnson, T; Rowinsky, EK; Statkevich, P; Villalona-Calero, M; Von Hoff, DD, 1999)
"90 hours, on average, and elimination was rapid, with a half-life and systemic clearance rate (Cl(S/F)) averaging 1."	2.69	Phase I and pharmacokinetic study of temozolomide on a daily-for-5-days schedule in patients with advanced solid malignancies. ( Baker, SD; Dugan, M; Eckardt, JR; Eckhardt, SG; Forral, K; Hammond, LA; Reidenberg, P; Rinaldi, DA; Rowinsky, EK; Statkevich, P; Von Hoff, DD; Weiss, GR, 1999)
"Lymphopenia is common in patients treated with all doses and schedules of TMZ."	2.45	The safety of temozolomide in the treatment of malignancies. ( Hwu, WJ; Patel, SP; Trinh, VA, 2009)
"Temozolomide is an alkylating agent used frequently in the management of gliomas."	2.44	Prolonged and severe myelosuppression in two patients after low-dose temozolomide treatment- case study and review of literature. ( Brown, MP; Selva-Nayagam, S; Singhal, N, 2007)
"Temozolomide (TMZ) has established antineoplastic activity in the central nervous system in other disease states, with a favorable toxicity profile."	1.51	Temozolomide as a Single Agent Maintenance Therapy in Elderly Patients With Primary CNS Lymphoma. ( Brenner, A; Butler, MJ; Faivre, G; Le, I, 2019)
"There is no standard treatment for glioblastoma with elements of PNET (GBM-PNET)."	1.43	Craniospinal irradiation with concomitant and adjuvant temozolomide--a feasibility assessment of toxicity in patients with glioblastoma with a PNET component. ( Fersht, N; Mandeville, HC; Mycroft, J; O'Leary, B; Saran, F; Solda, F; Vaidya, S; Zacharoulis, S, 2016)
"A retrospective study assessing treatment-related toxicities in tumor-bearing cats treated with temozolomide (TMZ) alone or in combination with doxorubicin was conducted."	1.38	Treatment-related toxicities in tumor-bearing cats treated with temozolomide alone or in combination with doxorubicin: a pilot assessment. ( Dervisis, NG; Gagnon, J; Kitchell, BE, 2012)
"Nimotuzumab in combination with chemotherapy has moderate activity in patients with malignant gliomas and the toxicities are well tolerable, therefore, worth further investigation."	1.37	[Nimotuzumab in combination with chemotherapy for patients with malignant gliomas]. ( Chen, ZP; Jiang, XB; Mu, YG; Sai, K; Shen, D; Yang, QY; Zhang, XH, 2011)

Research

Studies (42)

Authors

Clinical Trials (8)

Trial Overview

Trial Outcomes

Determination of Maximum Tolerated Dose (MTD)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	2 (4.76)	18.2507
2000's	22 (52.38)	29.6817
2010's	13 (30.95)	24.3611
2020's	5 (11.90)	2.80

Authors	Studies
Wang, BC	1
Xiao, BY	1
Lin, GH	1
Garzio, K	1
McElroy, K	1
Grossman, S	1
Holdhoff, M	1
Ozer, B	1
Yankulina, O	1
Yang, DY	1
Cheng, X	1
Bu, XY	1
Yan, ZY	1
Qu, MQ	1
Zhao, YW	1
Kong, LF	1
Wang, YW	1
Luo, JC	1
Gilbar, PJ	1
Pokharel, K	1
Mangos, HM	1
Elinzano, H	1
Toms, S	1
Robison, J	1
Mohler, A	1
Carcieri, A	1
Cielo, D	1
Donnelly, J	1
Disano, D	1
Vatketich, J	1
Baekey, J	1
Sturtevant, A	1
MacKinnon, K	1
Wood, R	1
Safran, H	1
Saito, T	1
Sugiyama, K	1
Hama, S	1
Yamasaki, F	1
Takayasu, T	1
Nosaka, R	1
Muragaki, Y	1
Kawamata, T	1
Kurisu, K	1
Faivre, G	1
Butler, MJ	1
Le, I	1
Brenner, A	1
Hummel, TR	1
Wagner, L	1
Ahern, C	1
Fouladi, M	1
Reid, JM	1
McGovern, RM	1
Ames, MM	1
Gilbertson, RJ	1
Horton, T	1
Ingle, AM	1
Weigel, B	1
Blaney, SM	1
Gupta, T	1
Mohanty, S	1
Moiyadi, A	1
Jalali, R	1
Saif, MW	1
Kaley, K	1
Brennan, M	1
Garcon, MC	1
Rodriguez, G	1
Rodriguez, T	1
Wang, XX	1
Huang, HQ	1
Bai, B	1
Cai, QQ	1
Cai, QC	1
Gao, Y	1
Xia, YF	1
Xia, ZJ	1
Jiang, WQ	1
Schiff, D	2
Desjardins, A	2
Cloughesy, T	1
Mikkelsen, T	1
Glantz, M	1
Chamberlain, MC	1
Reardon, DA	2
Wen, PY	2
O'Leary, B	1
Mandeville, HC	1
Fersht, N	1
Solda, F	1
Mycroft, J	1
Zacharoulis, S	1
Vaidya, S	1
Saran, F	1
Kim, KB	1
Hwu, WJ	2
Papadopoulos, NE	1
Bedikian, AY	1
Camacho, LH	1
Ng, C	1
Hernandez, IM	1
Frost, AM	1
Jack, MA	1
Hwu, P	1
Armstrong, TS	1
Cao, Y	1
Scheurer, ME	1
Vera-Bolaños, E	1
Manning, R	1
Okcu, MF	1
Bondy, M	1
Zhou, R	1
Gilbert, MR	1
Zwinkels, H	1
Roon, K	1
Jeurissen, FJ	1
Taphoorn, MJ	1
Hop, WC	1
Vecht, CJ	1
Kefford, RF	1
Thomas, NP	1
Corrie, PG	1
Palmer, C	1
Abdi, E	1
Kotasek, D	1
Beith, J	1
Ranson, M	1
Mortimer, P	1
Watson, AJ	2
Margison, GP	2
Middleton, MR	2
Trinh, VA	1
Patel, SP	1
Casey, DA	1
Wexler, LH	1
Merchant, MS	1
Chou, AJ	1
Merola, PR	1
Price, AP	1
Meyers, PA	1
Drappatz, J	1
Norden, AD	1
Wong, ET	1
Doherty, LM	1
Lafrankie, DC	1
Ciampa, A	1
Kesari, S	1
Sceppa, C	1
Gerard, M	1
Phan, P	1
Batchelor, TT	1
Ligon, KL	1
Young, G	1
Muzikansky, A	1
Weiss, SE	1
Yang, QY	1
Shen, D	1
Sai, K	2
Mu, YG	2
Jiang, XB	1
Zhang, XH	2
Chen, ZP	2
Minniti, G	1
Lanzetta, G	1
Scaringi, C	1
Caporello, P	1
Salvati, M	1
Arcella, A	1
De Sanctis, V	1
Giangaspero, F	1
Enrici, RM	1
Vredenburgh, JJ	1
Herndon, JE	1
Coan, A	1
Gururangan, S	1
Peters, KB	1
McLendon, R	1
Sathornsumetee, S	1
Rich, JN	1
Lipp, ES	1
Janney, D	1
Friedman, HS	1
Gagnon, J	1
Dervisis, NG	1
Kitchell, BE	1
Agarwala, SS	2
Kirkwood, JM	1
Riccardi, A	1
Mazzarella, G	2
Cefalo, G	2
Garrè, ML	2
Massimino, M	2
Barone, C	1
Sandri, A	2
Ridola, V	2
Ruggiero, A	2
Mastrangelo, S	1
Lazzareschi, I	2
Caldarelli, M	2
Maira, G	1
Madon, E	2
Riccardi, R	2
Rudek, MA	1
Donehower, RC	1
Statkevich, P	3
Batra, VK	2
Cutler, DL	2
Baker, SD	3
Awada, A	1
Gil, T	1
Sales, F	1
Dubuisson, M	1
Vereecken, P	1
Klastersky, J	1
Moerman, C	1
de Valeriola, D	1
Piccart, MJ	1
Seiter, K	1
Liu, D	1
Siddiqui, AD	1
Lerner, R	1
Nelson, J	1
Ahmed, T	1
Plummer, ER	1
Jones, C	1
Olsen, A	1
Hickson, I	1
McHugh, P	1
McGown, G	1
Thorncroft, M	1
Boddy, AV	1
Calvert, AH	1
Harris, AL	1
Newell, DR	1
Curtin, NJ	1
Colosimo, C	1
Attinà, G	1
Maurizi, P	1
Di Rocco, C	1
Abate, ME	1
Clerico, A	1
Omuro, AM	1
Raizer, JJ	1
Demopoulos, A	1
Malkin, MG	1
Abrey, LE	1
Gerber, DE	1
Grossman, SA	1
Zeltzman, M	1
Parisi, MA	1
Kleinberg, L	1
Larkin, JM	1
Hughes, SA	1
Beirne, DA	1
Patel, PM	1
Gibbens, IM	1
Bate, SC	1
Thomas, K	1
Eisen, TG	1
Gore, ME	1
Zhang, JP	1
Shi, HL	1
Yue, WY	1
Soetekouw, PM	1
Gijtenbeek, JM	1
van der Maazen, RW	1
Kappelle, AC	1
van Herpen, CM	1
Singhal, N	1
Selva-Nayagam, S	1
Brown, MP	1
Britten, CD	1
Rowinsky, EK	2
Eckardt, JR	2
Barrington, R	1
Diab, SG	1
Hammond, LA	2
Johnson, T	1
Villalona-Calero, M	1
Fraass, U	1
Von Hoff, DD	2
Eckhardt, SG	2
Dugan, M	1
Forral, K	1
Reidenberg, P	1
Weiss, GR	1
Rinaldi, DA	1
Jen, JF	1
Pai, SM	1
Affrime, MB	1
Zambas, DN	1
Heft, S	1
Hajian, G	1
Spiro, TP	1
Liu, L	1
Majka, S	1
Haaga, J	1
Willson, JK	1
Gerson, SL	1
Bafaloukos, D	1
Gogas, H	1
Georgoulias, V	1
Briassoulis, E	1
Fountzilas, G	1
Samantas, E	1
Kalofonos, Ch	1
Skarlos, D	1
Karabelis, A	1
Kosmidis, P	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
BrUOG 329: Onivyde (Nanoliposomal Irinotecan) and Metronomic Temozolomide for Patients With Recurrent Glioblastoma: A Phase IB/IIA Brown University Oncology Research Group Study[NCT03119064]	Phase 1/Phase 2	12 participants (Actual)	Interventional	2017-11-30	Terminated (stopped due to lack of response to study therapy)
A Phase I Study of SAHA and Temozolomide in Children With Relapsed or Refractory Primary Brain or Spinal Cord Tumors[NCT01076530]	Phase 1	27 participants (Actual)	Interventional	2010-02-28	Completed
Clinical Study of Radiopeptide 177Lu-DOTATOC in Combination With Capecitabine and Temozolomide in Advanced, Non-resectable and Progressive Neuroendocrine Tumors With Somatostatin Receptor Overexpression[NCT04194125]	Phase 2	25 participants (Anticipated)	Interventional	2019-02-01	Recruiting
Secondary Prophylaxis Use of Romiplostim for the Prevention of Thrombocytopenia Induced by Temozolomide in Newly Diagnosed Glioblastoma Patients[NCT02227576]	Phase 2	20 participants (Actual)	Interventional	2014-07-10	Terminated (stopped due to Study halted for efficacy following the results of the interim analysis provided for in the protocol on 20 patients.)
Assessment of MGMT Promoter Methylation and Clinical Benefit From Temozolomide-based Therapy in Ewing Sarcoma Patients[NCT03542097]		82 participants (Actual)	Observational	2014-04-15	Completed
A Phase 2a Study of the Addition of Temozolomide to a Standard Conditioning Regimen for Autologous Stem Cell Transplantation in Relapsed and Refractory Central Nervous System (CNS) Lymphoma[NCT01235793]	Phase 2	11 participants (Actual)	Interventional	2010-10-14	Terminated (stopped due to The clinical trial was terminated due to poor enrollment)
Phase II Study of Gamma Knife Radiosurgery and Temozolomide (Temodar) for Newly Diagnosed Brain Metastases[NCT00582075]	Phase 2	25 participants (Actual)	Interventional	2002-07-31	Completed
A Pilot Study Investigating Neoadjuvant Temozolomide-based Proton Chemoradiotherapy for High-Risk Soft Tissue Sarcomas[NCT00881595]	Phase 2	0 participants (Actual)	Interventional	2009-02-28	Withdrawn (stopped due to No patients accrued since study opened)
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

To evaluate the maximum tolerated dose of nanoliposomal irinotecan with continuous low-dose temozolomide for patients with recurrent glioblastoma. (NCT03119064)
Timeframe: Every two weeks for 4 weeks

Response

Intervention	mg/m^2 (Number)
All Participants	50

"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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." (NCT03119064)
Timeframe: Every 2 months on study treatment then very 3 months once treatment has stopped, until progression of disease up to 2 years.

Toxicities

Intervention	participants (Number)
	Partial Response	Progressive Disease
Dose 1	1	8
Dose 2	1	2

Treatment emergent toxicities of nanoliposomal irinotecan with continuous low-dose temozolomide using CTCAE version 4.03, grades 2 through 4 (NCT03119064)
Timeframe: Baseline through 30 days post off study treatment

Safest Dose of Temozolomide for the DRBEAT Regimen

Intervention	events (Number)
	Neutropenia	ALT/AST	Hypokalemia	Hypophosphatemia	Nausea	Fatigue	Diarrhea	Anorexia	Dehydration	Urticaria
Dose 1	0	2	1	1	1	2	0	0	0	1
Dose 2	1	1	1	0	2	2	2	2	2	0

Safety will be assessed using a dose escalation design for temozolomide's use to determine the target dose and also to evaluate any and all acute treatment related toxicities. During the course of patient follow up and therapy, toxicities will be evaluated, particularly as the investigators will be determining the target dose of temozolomide. One of the major criteria for dose limiting toxicity for the study will be any Grade 3 or 4 nonhematologic toxicity from a list of commonly expected toxicities associated with autologous transplantation and temozolomide. (NCT01235793)
Timeframe: One Year

One-year Progression-free Survival and Overall Survival

Intervention	dose in mg/m^2 (Number)
DRBEAT Regimen	773.25

"Efficacy of the DRBEAT Regimen will be assessed by analysis of~one-year progression-free survival (PFS), defined as the time interval from maximal response from therapy to tumor regrowth, progression*, or death, (*Progression is defined as meeting the response criteria listed in Table 4: Response Criteria for Primary Central Nervous System Lymphoma according to Abrey LE, Batchelor TT, Ferreri AJM et al.)~and~Overall survival, defined as the time interval between the date of transplant and the date of death from any cause." (NCT01235793)
Timeframe: (1) One Year (2) Until date of death from any cause, assessed up to 2 years

Overall Survival

Percentage of Participants With Distant Brain Failure (DBF) at One Year

Intervention	Days (Median)
	Progression Free Survival	Overall Survival
DRBEAT Regimen	132	564

Intervention	weeks (Median)
Radiosurgery 15-24 Gy + Adjuvant Temozolomide	31

Patients developing distant brain failure (DBF) at one year. An approximation method was used to arrive at the reported percentage. (NCT00582075)
Timeframe: 1 years

temozolomide and Neutropenia