thalidomide has been researched along with Benign Supratentorial Neoplasms in 2 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Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.
| Excerpt | Relevance | Reference |
|---|---|---|
| "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." | 9.14 | 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. ( 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 was well tolerated, with constipation and sedation being the major toxicities." | 9.09 | Phase 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) |
| "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." | 5.14 | 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. ( 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 was well tolerated, with constipation and sedation being the major toxicities." | 5.09 | Phase 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) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 1 (50.00) | 29.6817 |
| 2010's | 1 (50.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Gilbert, MR | 1 |
| Gonzalez, J | 1 |
| Hunter, K | 1 |
| Hess, K | 1 |
| Giglio, P | 1 |
| Chang, E | 1 |
| Puduvalli, V | 1 |
| Groves, MD | 1 |
| Colman, H | 1 |
| Conrad, C | 1 |
| Levin, V | 1 |
| Woo, S | 1 |
| Mahajan, A | 1 |
| de Groot, J | 1 |
| Yung, WK | 2 |
| Fine, HA | 1 |
| Figg, WD | 1 |
| Jaeckle, K | 1 |
| Wen, PY | 1 |
| Kyritsis, AP | 1 |
| Loeffler, JS | 1 |
| Levin, VA | 1 |
| Black, PM | 1 |
| Kaplan, R | 1 |
| Pluda, JM | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| 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 2 | 178 participants (Actual) | Interventional | 2005-09-30 | Completed | ||
| A Phase II Study of Peg-Interferon Alpha-2B (Peg-Intron(TM)) and Thalidomide in Adults With Recurrent High-Grade Gliomas[NCT00047879] | Phase 2 | 7 participants (Actual) | Interventional | 2002-10-31 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
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.
| Intervention | months (Median) |
|---|---|
| Celecoxib: Arm III, Arm V, Arm VI and Arm VIII | 20.2 |
| No Celecoxib: Arm I, Arm II, Arm IV and Arm VII | 17.1 |
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.
| Intervention | months (Median) |
|---|---|
| Doublet (2 Agents): Arm II, Arm III and Arm IV | 17.0 |
| Triplet (3 Agents): Arm V, Arm VI and Arm VII | 20.1 |
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.
| Intervention | months (Median) |
|---|---|
| Isotretinoin: Arm IV, Arm V, Arm VII and ARM VIII | 17.1 |
| No Isotretinoin: Arm I, Arm II, Arm III and ARM VI | 19.9 |
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.
| Intervention | months (Median) |
|---|---|
| Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII | 18.3 |
| No Thalidomide: Arm I, Arm III, Arm IV and Arm V | 17.4 |
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.
| Intervention | months (Median) |
|---|---|
| Celecoxib: Arm III, Arm V, Arm VI and Arm VIII | 8.3 |
| No Celecoxib: Arm I, Arm II, Arm IV and Arm VII | 7.4 |
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.
| Intervention | months (Median) |
|---|---|
| Doublet (2 Agents): Arm II, Arm III and Arm IV | 8.3 |
| Triplet (3 Agents): Arm V, Arm VI and Arm VII | 8.2 |
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.
| Intervention | months (Median) |
|---|---|
| Isotretinoin: Arm IV, Arm V, Arm VII and Arm VIII | 6.6 |
| No Isotretinoin: Arm I, Arm II, Arm III and Arm VI | 9.1 |
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).
| Intervention | months (Median) |
|---|---|
| Thalidomide: Arm II, Arm VI, Arm VII and Arm VIII | 7.6 |
| No Thalidomide: Arm I, Arm III, Arm IV and Arm V | 8.7 |
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.
| Intervention | months (Median) |
|---|---|
| Arm I: TMZ | 10.5 |
| Arm II: TMZ + Thalidomide | 7.7 |
| Arm III: TMZ + Celecoxib | 13.4 |
| Arm IV: TMZ + Isotretinoin | 6.5 |
| Arm V: TMZ + Isotretinoin + Celecoxib | 11.6 |
| Arm VI: TMZ + Thalidomide + Celecoxib | 7.9 |
| Arm VII: TMZ + Thalidomide + Isotretinoin | 6.2 |
| Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib | 5.8 |
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.
| Intervention | months (Median) |
|---|---|
| Arm I: TMZ | 21.2 |
| Arm II: TMZ + Thalidomide | 17.4 |
| Arm III: TMZ + Celecoxib | 18.1 |
| Arm IV: TMZ + Isotretinoin | 11.7 |
| Arm V: TMZ + Isotretinoin + Celecoxib | 23.1 |
| Arm VI: TMZ + Thalidomide + Celecoxib | 20.2 |
| Arm VII: TMZ + Thalidomide + Isotretinoin | 17.9 |
| Arm VIII: TMZ + Thalidomide + Isotretinoin + Celecoxib | 18.5 |
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
| Intervention | Participants (Number) |
|---|---|
| Glioblastoma Multiforme Stratum | 4 |
| Anaplastic Glioma Stratum | 2 |
2 trials available for thalidomide and Benign Supratentorial Neoplasms
| Article | Year |
|---|---|
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.
Topics: Adolescent; Adult; Aged; Antineoplastic Agents; Celecoxib; Chemotherapy, Adjuvant; Combined Modality | 2010 |
Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas.
Topics: Adult; Aged; Angiogenesis Inhibitors; Biomarkers, Tumor; Chemotherapy, Adjuvant; Combined Modality T | 2000 |