Page last updated: 2024-11-05

thalidomide and Astrocytoma, Grade IV

thalidomide has been researched along with Astrocytoma, Grade IV in 24 studies

Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.

Research Excerpts

ExcerptRelevanceReference
"Chemoradiation, followed by adjuvant temozolomide, is the standard treatment for newly diagnosed glioblastoma."9.20Randomized phase II adjuvant factorial study of dose-dense temozolomide alone and in combination with isotretinoin, celecoxib, and/or thalidomide for glioblastoma. ( Aldape, KD; Chang, EL; Colman, H; Conrad, CA; De Groot, JF; Fisch, MJ; Floyd, JD; Giglio, P; Gilbert, MR; Gonzalez, J; Groves, MD; Hess, KR; Hsu, SH; Lagrone, LW; Levin, VA; Loghin, ME; Mahajan, A; Penas-Prado, M; Puduvalli, VK; Salacz, ME; Volas-Redd, G; Woo, SY; Yung, WK, 2015)
"The Radiation Therapy Oncology Group (RTOG) initiated the single-arm, phase II study 9806 to determine the safety and efficacy of daily thalidomide with radiation therapy in patients with newly diagnosed glioblastoma."9.17A phase II study of conventional radiation therapy and thalidomide for supratentorial, newly-diagnosed glioblastoma (RTOG 9806). ( Alexander, BM; Curran, WJ; Donahue, BA; Fine, HA; Hartford, AC; Kerlin, KJ; Mehta, MP; Richards, RS; Tremont, IW; Wang, M; Yung, WK, 2013)
"To define the maximum tolerated dose (MTD) of lenalidomide, an analogue of thalidomide with enhanced immunomodulatory and antiangiogenic properties and a more favorable toxicity profile, in patients with newly diagnosed glioblastoma multiforme (GBM) when given concurrently with radiotherapy."9.14A pilot safety study of lenalidomide and radiotherapy for patients with newly diagnosed glioblastoma multiforme. ( Barron, L; Batchelor, TT; Black, PM; Ciampa, A; David, K; Doherty, L; Drappatz, J; Kesari, S; Lafrankie, DC; Norden, A; Ostrowsky, L; Ramakrishna, N; Sceppa, C; Schiff, D; Smith, ST; Weiss, S; Wen, PY; Wong, ET; Zimmerman, J, 2009)
"External beam radiation therapy (XRT) with concomitant temozolomide and 6 cycles of adjuvant temozolomide (5/28-day schedule) improves survival in patients with newly diagnosed glioblastoma compared with XRT alone."9.14A phase I factorial design study of dose-dense temozolomide alone and in combination with thalidomide, isotretinoin, and/or celecoxib as postchemoradiation adjuvant therapy for newly diagnosed glioblastoma. ( Chang, E; Colman, H; Conrad, C; de Groot, J; Giglio, P; Gilbert, MR; Gonzalez, J; Groves, MD; Hess, K; Hunter, K; Levin, V; Mahajan, A; Puduvalli, V; Woo, S; Yung, WK, 2010)
" Thalidomide, an antiangiogenic agent, may play a role in the treatment of glioblastoma multiforme (GBM)."9.13A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme. ( Cole, BF; Eskey, CJ; Fadul, CE; Kingman, LS; Meyer, LP; Newton, HB; Pipas, JM; Rhodes, CH; Roberts, DW, 2008)
"This phase II study aimed at determining the efficacy and safety of irinotecan combined with thalidomide in adults with recurrent glioblastoma multiforme (GBM) not taking enzyme-inducing anticonvulsants (EIACs)."9.13Phase II trial of irinotecan and thalidomide in adults with recurrent glioblastoma multiforme. ( Colman, H; Conrad, CA; de Groot, JF; Giglio, P; Gilbert, MR; Groves, MD; Hess, KR; Hsu, SH; Ictech, SE; Jackson, EF; Levin, VA; Mahankali, S; Puduvalli, VK; Ritterhouse, MG; Yung, WK, 2008)
"We conducted a phase II study of the combination of temozolomide and angiogenesis inhibitors for treating adult patients with newly diagnosed glioblastoma."9.13Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults. ( Batchelor, TT; Black, PM; Ciampa, A; Doherty, L; Drappatz, J; Folkman, J; Gigas, DC; Henson, JW; Kesari, S; Kieran, M; Laforme, A; Ligon, KL; Longtine, JA; Muzikansky, A; Ramakrishna, N; Schiff, D; Weaver, S; Wen, PY, 2008)
"A phase II study was conducted to assess the efficacy of administering daily thalidomide concomitantly with radiation and continuing for up to 1 year following radiation in children with brain stem gliomas (BSG) or glioblastoma multiforme (GBM)."9.12Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme. ( Briody, C; Chi, S; Chordas, C; Goumnerova, LC; Kieran, MW; MacDonald, T; Marcus, KJ; Packer, RJ; Poussaint, TY; Scott, RM; Turner, CD; Ullrich, N; Vajapeyam, S; Zimmerman, MA, 2007)
"Laboratory and clinical data suggest that the anti-angiogenic agent, thalidomide, if combined with cytotoxic agents, may be effective against recurrent glioblastoma multiforme (GBM)."9.12A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme. ( Abrey, LE; Chang, SM; Cloughesy, TF; Conrad, CA; DeAngelis, LM; Gilbert, MR; Greenberg, H; Groves, MD; Hess, KR; Lamborn, KR; Liu, TJ; Peterson, P; Prados, MD; Puduvalli, VK; Schiff, D; Tremont-Lukats, IW; Wen, PY; Yung, WK, 2007)
" Thalidomide was well tolerated, with constipation and sedation being the major toxicities."9.09Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. ( Black, PM; Figg, WD; Fine, HA; Jaeckle, K; Kaplan, R; Kyritsis, AP; Levin, VA; Loeffler, JS; Pluda, JM; Wen, PY; Yung, WK, 2000)
"For its numerous abilities including sedation, we have been using thalidomide (TH) as the 'last therapeutic option' in patients with advanced gliomas."7.81Thalidomide as palliative treatment in patients with advanced secondary glioblastoma. ( Ackerl, M; Dieckmann, KU; Flechl, B; Hainfellner, JA; Hassler, MR; Marosi, C; Prayer, D; Preusser, M; Rössler, K; Sax, C; Woehrer, A, 2015)
"13-cis-retinoic acid (RA) and thalidomide have shown a synergistic anti-proliferative effect on U343 glioblastoma (GBM) cells."7.80The influence of retinoic Acid and thalidomide on the radiosensitivity of u343 glioblastoma cells. ( Herskind, C; Maier, P; Milanović, D; Schanne, DH; Wenz, F, 2014)
"Thalidomide was well tolerated: the most common side effects were constipation (76."6.71Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma. ( Carillio, G; Fanelli, M; Gasparini, G; Gattuso, D; Morabito, A; Sarmiento, R, 2004)
"Temozolomide was administered starting the first day of RT at 150 mg/m(2) daily for 5 days every 4 weeks for the first cycle and escalated to a maximum dose of 200 mg/m(2)."6.71Phase II study of temozolomide and thalidomide with radiation therapy for newly diagnosed glioblastoma multiforme. ( Chang, SM; Lamborn, KR; Larson, D; Malec, M; Nicholas, MK; Page, M; Prados, MD; Rabbitt, J; Sneed, P; Wara, W, 2004)
"Thalidomide is a well-tolerated drug that may have some activity in the treatment of recurrent glioblastoma."6.70Phase II study of thalidomide in the treatment of recurrent glioblastoma multiforme. ( Bell, DR; Biggs, M; Boyle, FM; Cook, R; Levi, JA; Little, N; Marx, GM; McCowatt, S; Pavlakis, N; Wheeler, HR, 2001)
"Chemoradiation, followed by adjuvant temozolomide, is the standard treatment for newly diagnosed glioblastoma."5.20Randomized phase II adjuvant factorial study of dose-dense temozolomide alone and in combination with isotretinoin, celecoxib, and/or thalidomide for glioblastoma. ( Aldape, KD; Chang, EL; Colman, H; Conrad, CA; De Groot, JF; Fisch, MJ; Floyd, JD; Giglio, P; Gilbert, MR; Gonzalez, J; Groves, MD; Hess, KR; Hsu, SH; Lagrone, LW; Levin, VA; Loghin, ME; Mahajan, A; Penas-Prado, M; Puduvalli, VK; Salacz, ME; Volas-Redd, G; Woo, SY; Yung, WK, 2015)
"The Radiation Therapy Oncology Group (RTOG) initiated the single-arm, phase II study 9806 to determine the safety and efficacy of daily thalidomide with radiation therapy in patients with newly diagnosed glioblastoma."5.17A phase II study of conventional radiation therapy and thalidomide for supratentorial, newly-diagnosed glioblastoma (RTOG 9806). ( Alexander, BM; Curran, WJ; Donahue, BA; Fine, HA; Hartford, AC; Kerlin, KJ; Mehta, MP; Richards, RS; Tremont, IW; Wang, M; Yung, WK, 2013)
"To define the maximum tolerated dose (MTD) of lenalidomide, an analogue of thalidomide with enhanced immunomodulatory and antiangiogenic properties and a more favorable toxicity profile, in patients with newly diagnosed glioblastoma multiforme (GBM) when given concurrently with radiotherapy."5.14A pilot safety study of lenalidomide and radiotherapy for patients with newly diagnosed glioblastoma multiforme. ( Barron, L; Batchelor, TT; Black, PM; Ciampa, A; David, K; Doherty, L; Drappatz, J; Kesari, S; Lafrankie, DC; Norden, A; Ostrowsky, L; Ramakrishna, N; Sceppa, C; Schiff, D; Smith, ST; Weiss, S; Wen, PY; Wong, ET; Zimmerman, J, 2009)
"External beam radiation therapy (XRT) with concomitant temozolomide and 6 cycles of adjuvant temozolomide (5/28-day schedule) improves survival in patients with newly diagnosed glioblastoma compared with XRT alone."5.14A phase I factorial design study of dose-dense temozolomide alone and in combination with thalidomide, isotretinoin, and/or celecoxib as postchemoradiation adjuvant therapy for newly diagnosed glioblastoma. ( Chang, E; Colman, H; Conrad, C; de Groot, J; Giglio, P; Gilbert, MR; Gonzalez, J; Groves, MD; Hess, K; Hunter, K; Levin, V; Mahajan, A; Puduvalli, V; Woo, S; Yung, WK, 2010)
" Thalidomide, an antiangiogenic agent, may play a role in the treatment of glioblastoma multiforme (GBM)."5.13A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme. ( Cole, BF; Eskey, CJ; Fadul, CE; Kingman, LS; Meyer, LP; Newton, HB; Pipas, JM; Rhodes, CH; Roberts, DW, 2008)
"This phase II study aimed at determining the efficacy and safety of irinotecan combined with thalidomide in adults with recurrent glioblastoma multiforme (GBM) not taking enzyme-inducing anticonvulsants (EIACs)."5.13Phase II trial of irinotecan and thalidomide in adults with recurrent glioblastoma multiforme. ( Colman, H; Conrad, CA; de Groot, JF; Giglio, P; Gilbert, MR; Groves, MD; Hess, KR; Hsu, SH; Ictech, SE; Jackson, EF; Levin, VA; Mahankali, S; Puduvalli, VK; Ritterhouse, MG; Yung, WK, 2008)
"We conducted a phase II study of the combination of temozolomide and angiogenesis inhibitors for treating adult patients with newly diagnosed glioblastoma."5.13Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults. ( Batchelor, TT; Black, PM; Ciampa, A; Doherty, L; Drappatz, J; Folkman, J; Gigas, DC; Henson, JW; Kesari, S; Kieran, M; Laforme, A; Ligon, KL; Longtine, JA; Muzikansky, A; Ramakrishna, N; Schiff, D; Weaver, S; Wen, PY, 2008)
"A phase II study was conducted to assess the efficacy of administering daily thalidomide concomitantly with radiation and continuing for up to 1 year following radiation in children with brain stem gliomas (BSG) or glioblastoma multiforme (GBM)."5.12Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme. ( Briody, C; Chi, S; Chordas, C; Goumnerova, LC; Kieran, MW; MacDonald, T; Marcus, KJ; Packer, RJ; Poussaint, TY; Scott, RM; Turner, CD; Ullrich, N; Vajapeyam, S; Zimmerman, MA, 2007)
"Laboratory and clinical data suggest that the anti-angiogenic agent, thalidomide, if combined with cytotoxic agents, may be effective against recurrent glioblastoma multiforme (GBM)."5.12A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme. ( Abrey, LE; Chang, SM; Cloughesy, TF; Conrad, CA; DeAngelis, LM; Gilbert, MR; Greenberg, H; Groves, MD; Hess, KR; Lamborn, KR; Liu, TJ; Peterson, P; Prados, MD; Puduvalli, VK; Schiff, D; Tremont-Lukats, IW; Wen, PY; Yung, WK, 2007)
" Thalidomide was well tolerated, with constipation and sedation being the major toxicities."5.09Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. ( Black, PM; Figg, WD; Fine, HA; Jaeckle, K; Kaplan, R; Kyritsis, AP; Levin, VA; Loeffler, JS; Pluda, JM; Wen, PY; Yung, WK, 2000)
"For its numerous abilities including sedation, we have been using thalidomide (TH) as the 'last therapeutic option' in patients with advanced gliomas."3.81Thalidomide as palliative treatment in patients with advanced secondary glioblastoma. ( Ackerl, M; Dieckmann, KU; Flechl, B; Hainfellner, JA; Hassler, MR; Marosi, C; Prayer, D; Preusser, M; Rössler, K; Sax, C; Woehrer, A, 2015)
"13-cis-retinoic acid (RA) and thalidomide have shown a synergistic anti-proliferative effect on U343 glioblastoma (GBM) cells."3.80The influence of retinoic Acid and thalidomide on the radiosensitivity of u343 glioblastoma cells. ( Herskind, C; Maier, P; Milanović, D; Schanne, DH; Wenz, F, 2014)
" Although thalidomide-induced dermatologic disorders rarely were reported before thalidomide was administered to patients positive for the human immunodeficiency virus, hypersensitivity reactions including rash are the agent's major dose-limiting toxicities in this population."3.70Thalidomide-induced toxic epidermal necrolysis. ( Horowitz, SB; Stirling, AL, 1999)
"Thalidomide was well tolerated: the most common side effects were constipation (76."2.71Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma. ( Carillio, G; Fanelli, M; Gasparini, G; Gattuso, D; Morabito, A; Sarmiento, R, 2004)
"Temozolomide was administered starting the first day of RT at 150 mg/m(2) daily for 5 days every 4 weeks for the first cycle and escalated to a maximum dose of 200 mg/m(2)."2.71Phase II study of temozolomide and thalidomide with radiation therapy for newly diagnosed glioblastoma multiforme. ( Chang, SM; Lamborn, KR; Larson, D; Malec, M; Nicholas, MK; Page, M; Prados, MD; Rabbitt, J; Sneed, P; Wara, W, 2004)
"Thalidomide is a well-tolerated drug that may have some activity in the treatment of recurrent glioblastoma."2.70Phase II study of thalidomide in the treatment of recurrent glioblastoma multiforme. ( Bell, DR; Biggs, M; Boyle, FM; Cook, R; Levi, JA; Little, N; Marx, GM; McCowatt, S; Pavlakis, N; Wheeler, HR, 2001)
" Additionally, we investigated a potential enhancement of the antitumoral action of thalidomide when combined with a low dose of the antineoplastic carmustine."1.31Antiproliferative effect of thalidomide alone and combined with carmustine against C6 rat glioma. ( Arrieta, O; Guevara, P; Rembao, D; Rivera, E; Sotelo, J; Tamariz, J, 2002)

Research

Studies (24)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (4.17)18.2507
2000's14 (58.33)29.6817
2010's8 (33.33)24.3611
2020's1 (4.17)2.80

Authors

AuthorsStudies
Luo, Z1
Wang, B1
Liu, H1
Shi, L1
Guo, G1
Gong, K1
Puliyappadamba, VT1
Panchani, N1
Pan, E1
Mukherjee, B1
Damanwalla, Z1
Bharia, S1
Hatanpaa, KJ1
Gerber, DE1
Mickey, BE1
Patel, TR1
Sarkaria, JN1
Zhao, D1
Burma, S1
Habib, AA1
Milanović, D2
Maier, P2
Schanne, DH1
Wenz, F2
Herskind, C2
Penas-Prado, M1
Hess, KR3
Fisch, MJ1
Lagrone, LW1
Groves, MD4
Levin, VA3
De Groot, JF2
Puduvalli, VK3
Colman, H3
Volas-Redd, G1
Giglio, P3
Conrad, CA3
Salacz, ME1
Floyd, JD1
Loghin, ME1
Hsu, SH2
Gonzalez, J2
Chang, EL1
Woo, SY1
Mahajan, A2
Aldape, KD1
Yung, WK6
Gilbert, MR4
Hassler, MR1
Sax, C1
Flechl, B1
Ackerl, M1
Preusser, M1
Hainfellner, JA1
Woehrer, A1
Dieckmann, KU1
Rössler, K1
Prayer, D1
Marosi, C1
Iwamoto, FM1
Lassman, AB1
Wang, Y1
Xing, D1
Zhao, M1
Wang, J1
Yang, Y1
Drappatz, J2
Wong, ET1
Schiff, D3
Kesari, S2
Batchelor, TT2
Doherty, L2
Lafrankie, DC1
Ramakrishna, N2
Weiss, S1
Smith, ST1
Ciampa, A2
Zimmerman, J1
Ostrowsky, L1
David, K1
Norden, A1
Barron, L1
Sceppa, C1
Black, PM3
Wen, PY4
Fadul, CE1
Kingman, LS1
Meyer, LP1
Cole, BF1
Eskey, CJ1
Rhodes, CH1
Roberts, DW1
Newton, HB1
Pipas, JM1
Aguilera, DG1
Tomita, T1
Rajaram, V1
Fangusaro, J1
Katz, BZ1
Shulman, S1
Goldman, S1
Hunter, K1
Hess, K1
Chang, E1
Puduvalli, V1
Conrad, C1
Levin, V1
Woo, S1
de Groot, J1
Alexander, BM1
Wang, M1
Fine, HA2
Donahue, BA1
Tremont, IW1
Richards, RS1
Kerlin, KJ1
Hartford, AC1
Curran, WJ1
Mehta, MP1
Morabito, A1
Fanelli, M1
Carillio, G1
Gattuso, D1
Sarmiento, R1
Gasparini, G1
Phuphanich, S1
Chang, SM2
Lamborn, KR2
Malec, M1
Larson, D1
Wara, W1
Sneed, P1
Rabbitt, J1
Page, M1
Nicholas, MK1
Prados, MD2
Turner, CD1
Chi, S1
Marcus, KJ1
MacDonald, T1
Packer, RJ1
Poussaint, TY1
Vajapeyam, S1
Ullrich, N1
Goumnerova, LC1
Scott, RM1
Briody, C1
Chordas, C1
Zimmerman, MA1
Kieran, MW1
Tremont-Lukats, IW1
Liu, TJ1
Peterson, P1
Cloughesy, TF1
Greenberg, H1
Abrey, LE1
DeAngelis, LM1
Lohr, F1
Mahankali, S1
Jackson, EF1
Ritterhouse, MG1
Ictech, SE1
Henson, JW1
Muzikansky, A1
Gigas, DC1
Longtine, JA1
Ligon, KL1
Weaver, S1
Laforme, A1
Folkman, J1
Kieran, M1
Horowitz, SB1
Stirling, AL1
Figg, WD1
Jaeckle, K1
Kyritsis, AP1
Loeffler, JS1
Kaplan, R1
Pluda, JM1
Marx, GM1
Pavlakis, N1
McCowatt, S1
Boyle, FM1
Levi, JA1
Bell, DR1
Cook, R1
Biggs, M1
Little, N1
Wheeler, HR1
Arrieta, O1
Guevara, P1
Tamariz, J1
Rembao, D1
Rivera, E1
Sotelo, J1

Clinical Trials (5)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomized, Factorial-Design, Phase II Trial of Temozolomide Alone and in Combination With Possible Permutations of Thalidomide, Isotretinoin and/or Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme[NCT00112502]Phase 2178 participants (Actual)Interventional2005-09-30Completed
A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme[NCT00039468]Phase 226 participants (Actual)Interventional2002-03-31Completed
Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme[NCT00006358]Phase 244 participants (Actual)Interventional2000-06-13Completed
Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting[NCT00047294]Phase 20 participants Interventional2001-04-30Completed
A Phase II Study of Peg-Interferon Alpha-2B (Peg-Intron(TM)) and Thalidomide in Adults With Recurrent High-Grade Gliomas[NCT00047879]Phase 27 participants (Actual)Interventional2002-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Median Overall Survival (OS) Comparison of Celecoxib Arms Versus no Celecoxib Arms

Celecoxib versus not Celecoxib analysis: We compared the median OS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 3 months from randomization until progression of disease, death or last follow-up.

Interventionmonths (Median)
Celecoxib: Arm III, Arm V, Arm VI and Arm VIII20.2
No Celecoxib: Arm I, Arm II, Arm IV and Arm VII17.1

Median Overall Survival (OS) Comparison of Doublet Versus Triplet Therapy

Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median OS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 3 months from randomization until progression of disease, death or last follow-up.

Interventionmonths (Median)
Doublet (2 Agents): Arm II, Arm III and Arm IV17.0
Triplet (3 Agents): Arm V, Arm VI and Arm VII20.1

Median Overall Survival (OS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms

Isotretinoin versus not Isotretinoin analysis: We compared the median OS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 3 months from randomization until progression of disease, death or last follow-up.

Interventionmonths (Median)
Isotretinoin: Arm IV, Arm V, Arm VII and ARM VIII17.1
No Isotretinoin: Arm I, Arm II, Arm III and ARM VI19.9

Median Overall Survival (OS) Comparison of Thalidomide Arms Versus no Thalidomide Arms

Thalidomide versus not Thalidomide analysis: We compared the median OS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median OS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 3 months from randomization until progression of disease, death or last follow-up.

Interventionmonths (Median)
Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII18.3
No Thalidomide: Arm I, Arm III, Arm IV and Arm V17.4

Median Progression-Free Survival (PFS) Comparison of Celecoxib Arms Versus no Celecoxib Arms

Celecoxib versus not Celecoxib analysis: We compared the median PFS outcome of participants in arms III, V, VI and VIII, versus participants in arms I, II, IV and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.

Interventionmonths (Median)
Celecoxib: Arm III, Arm V, Arm VI and Arm VIII8.3
No Celecoxib: Arm I, Arm II, Arm IV and Arm VII7.4

Median Progression-Free Survival (PFS) Comparison of Doublet Versus Triplet Therapy

Doublet (2 agents) versus Triplet (3 agents) therapy analysis: We compared the median PFS outcome of participants in arms II, III, IV, versus participants in arms V, VI and VII. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.

Interventionmonths (Median)
Doublet (2 Agents): Arm II, Arm III and Arm IV8.3
Triplet (3 Agents): Arm V, Arm VI and Arm VII8.2

Median Progression-Free Survival (PFS) Comparison of Isotretinoin Arms Versus no Isotretinoin Arms

Isotretinoin versus not Isotretinoin analysis: We compared the median PFS outcome of participants in arms IV, V, VII and VIII, versus participants in arms I, II, III and VI. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.

Interventionmonths (Median)
Isotretinoin: Arm IV, Arm V, Arm VII and Arm VIII6.6
No Isotretinoin: Arm I, Arm II, Arm III and Arm VI9.1

Median Progression-Free Survival (PFS) Comparison of Thalidomide Arms Versus no Thalidomide Arms

Thalidomide versus not Thalidomide analysis: Comparison of median PFS outcome of participants in arms II, VI, VII and VIII, versus participants in arms I, III, IV and V. Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up, up to one year (12 study cycles).

Interventionmonths (Median)
Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII7.6
No Thalidomide: Arm I, Arm III, Arm IV and Arm V8.7

Median Progression-Free Survival (PFS) of Individual Arms

Median PFS was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 2 cycles (1 cycle = 28 days) from randomization until progression of disease, death or last follow-up.

Interventionmonths (Median)
Arm I: TMZ10.5
Arm II: TMZ + Thalidomide7.7
Arm III: TMZ + Celecoxib13.4
Arm IV: TMZ + Isotretinoin6.5
Arm V: TMZ + Isotretinoin + Celecoxib11.6
Arm VI: TMZ + Thalidomide + Celecoxib7.9
Arm VII: TMZ + Thalidomide + Isotretinoin6.2
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib5.8

Overall Survival of Individual Arms

Overall Survival (OS) was estimated using the Kaplan-Meier method from time of randomization to time of progression, death, or last follow-up. Progression defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). (NCT00112502)
Timeframe: Every 3 months from randomization until progression of disease, death or last follow-up.

Interventionmonths (Median)
Arm I: TMZ21.2
Arm II: TMZ + Thalidomide17.4
Arm III: TMZ + Celecoxib18.1
Arm IV: TMZ + Isotretinoin11.7
Arm V: TMZ + Isotretinoin + Celecoxib23.1
Arm VI: TMZ + Thalidomide + Celecoxib20.2
Arm VII: TMZ + Thalidomide + Isotretinoin17.9
Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib18.5

The Number of Participants With Adverse Events

Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module. (NCT00047879)
Timeframe: 4 months

InterventionParticipants (Number)
Glioblastoma Multiforme Stratum4
Anaplastic Glioma Stratum2

Reviews

1 review available for thalidomide and Astrocytoma, Grade IV

ArticleYear
The Role of a Single Angiogenesis Inhibitor in the Treatment of Recurrent Glioblastoma Multiforme: A Meta-Analysis and Systematic Review.
    PloS one, 2016, Volume: 11, Issue:3

    Topics: Angiogenesis Inhibitors; Bevacizumab; Glioblastoma; Humans; Recurrence; Salvage Therapy; Thalidomide

2016

Trials

13 trials available for thalidomide and Astrocytoma, Grade IV

ArticleYear
Randomized phase II adjuvant factorial study of dose-dense temozolomide alone and in combination with isotretinoin, celecoxib, and/or thalidomide for glioblastoma.
    Neuro-oncology, 2015, Volume: 17, Issue:2

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents, Alkylating; Brain Neoplasms; Cele

2015
A pilot safety study of lenalidomide and radiotherapy for patients with newly diagnosed glioblastoma multiforme.
    International journal of radiation oncology, biology, physics, 2009, Jan-01, Volume: 73, Issue:1

    Topics: Adult; Aged; Antineoplastic Agents; Brain Neoplasms; Combined Modality Therapy; Dose-Response Relati

2009
A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme.
    Journal of neuro-oncology, 2008, Volume: 90, Issue:2

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Camptothecin; Central Nervous System Ne

2008
A phase I factorial design study of dose-dense temozolomide alone and in combination with thalidomide, isotretinoin, and/or celecoxib as postchemoradiation adjuvant therapy for newly diagnosed glioblastoma.
    Neuro-oncology, 2010, Volume: 12, Issue:11

    Topics: Adolescent; Adult; Aged; Antineoplastic Agents; Celecoxib; Chemotherapy, Adjuvant; Combined Modality

2010
A phase II study of conventional radiation therapy and thalidomide for supratentorial, newly-diagnosed glioblastoma (RTOG 9806).
    Journal of neuro-oncology, 2013, Volume: 111, Issue:1

    Topics: Adolescent; Adult; Angiogenesis Inhibitors; Brain Neoplasms; Chemoradiotherapy; Female; Follow-Up St

2013
Thalidomide prolongs disease stabilization after conventional therapy in patients with recurrent glioblastoma.
    Oncology reports, 2004, Volume: 11, Issue:1

    Topics: Adult; Aged; Angiogenesis Inhibitors; Constipation; Disease Progression; Female; Glioblastoma; Heada

2004
Phase II study of temozolomide and thalidomide with radiation therapy for newly diagnosed glioblastoma multiforme.
    International journal of radiation oncology, biology, physics, 2004, Oct-01, Volume: 60, Issue:2

    Topics: Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Agents, Alkylating; Antineoplastic Combined Che

2004
Phase II study of thalidomide and radiation in children with newly diagnosed brain stem gliomas and glioblastoma multiforme.
    Journal of neuro-oncology, 2007, Volume: 82, Issue:1

    Topics: Adolescent; Angiogenesis Inhibitors; Brain Stem Neoplasms; Child; Combined Modality Therapy; Disease

2007
A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme.
    Journal of neuro-oncology, 2007, Volume: 81, Issue:3

    Topics: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasms; Dac

2007
Phase II trial of irinotecan and thalidomide in adults with recurrent glioblastoma multiforme.
    Neuro-oncology, 2008, Volume: 10, Issue:2

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasms; Camptothecin; Disease-

2008
Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults.
    Neuro-oncology, 2008, Volume: 10, Issue:3

    Topics: Adult; Aged; Angiogenesis Inhibitors; Antineoplastic Combined Chemotherapy Protocols; Brain Neoplasm

2008
Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2000, Volume: 18, Issue:4

    Topics: Adult; Aged; Angiogenesis Inhibitors; Biomarkers, Tumor; Chemotherapy, Adjuvant; Combined Modality T

2000
Phase II study of thalidomide in the treatment of recurrent glioblastoma multiforme.
    Journal of neuro-oncology, 2001, Volume: 54, Issue:1

    Topics: Adult; Aged; Antineoplastic Agents; Brain Neoplasms; Disease Progression; Endothelial Growth Factors

2001

Other Studies

10 other studies available for thalidomide and Astrocytoma, Grade IV

ArticleYear
TNF Inhibitor Pomalidomide Sensitizes Glioblastoma Cells to EGFR Inhibition.
    Annals of clinical and laboratory science, 2020, Volume: 50, Issue:4

    Topics: Animals; Antineoplastic Agents; Cell Line, Tumor; Cell Proliferation; Cell Survival; China; ErbB Rec

2020
Efficacy of EGFR plus TNF inhibition in a preclinical model of temozolomide-resistant glioblastoma.
    Neuro-oncology, 2019, 12-17, Volume: 21, Issue:12

    Topics: Afatinib; Animals; Antineoplastic Combined Chemotherapy Protocols; Apoptosis; Brain Neoplasms; Cell

2019
The influence of retinoic Acid and thalidomide on the radiosensitivity of u343 glioblastoma cells.
    Anticancer research, 2014, Volume: 34, Issue:4

    Topics: Antineoplastic Agents; Cell Culture Techniques; Cell Line, Tumor; Cell Survival; Dose-Response Relat

2014
Thalidomide as palliative treatment in patients with advanced secondary glioblastoma.
    Oncology, 2015, Volume: 88, Issue:3

    Topics: Adult; Antineoplastic Agents; Female; Glioblastoma; Glioma; Humans; Male; Palliative Care; Retrospec

2015
Factorial clinical trials: a new approach to phase II neuro-oncology studies.
    Neuro-oncology, 2015, Volume: 17, Issue:2

    Topics: Antineoplastic Agents, Alkylating; Brain Neoplasms; Dacarbazine; Female; Glioblastoma; Humans; Isotr

2015
Glioblastoma multiforme in a patient with chronic granulomatous disease treated with subtotal resection, radiation, and thalidomide: case report of a long-term survivor.
    Journal of pediatric hematology/oncology, 2009, Volume: 31, Issue:12

    Topics: Adolescent; Brain Neoplasms; Combined Modality Therapy; Craniotomy; Diagnosis, Differential; Female;

2009
Recurrent multicentric glioblastoma multiforme responds to thalidomide and chemotherapy.
    Oncology (Williston Park, N.Y.), 2002, Volume: 16, Issue:3

    Topics: Adult; Antineoplastic Agents; Glioblastoma; Humans; Male; Neoplasm Recurrence, Local; Thalidomide; T

2002
Inhibition of 13-cis retinoic acid-induced gene expression of homeobox B7 by thalidomide.
    International journal of cancer, 2007, Sep-15, Volume: 121, Issue:6

    Topics: Antineoplastic Combined Chemotherapy Protocols; Blotting, Western; Cell Line, Tumor; Cell Proliferat

2007
Thalidomide-induced toxic epidermal necrolysis.
    Pharmacotherapy, 1999, Volume: 19, Issue:10

    Topics: Angiogenesis Inhibitors; Female; Glioblastoma; Humans; Hypersensitivity; Middle Aged; Stevens-Johnso

1999
Antiproliferative effect of thalidomide alone and combined with carmustine against C6 rat glioma.
    International journal of experimental pathology, 2002, Volume: 83, Issue:2

    Topics: Angiogenesis Inhibitors; Animals; Antineoplastic Combined Chemotherapy Protocols; Carmustine; Cell D

2002