Clinical trial · Interventional
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
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
NCT00112502CI-TRIAL-00054511completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Isotretinoin may help cells that are involved in the body's immune response to work better. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which temozolomide-containing regimen is more effective in treating glioblastoma multiforme. PURPOSE: This randomized phase II trial is studying eight different temozolomide-containing regimens to compare how well they work in treating patients who have undergone radiation therapy for glioblastoma multiforme.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Isotretinoin | Drug | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
| Thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- ACTIVE_COMPARATOR
- label
- Arm I: TMZ
- description
- Oral Temozolomide (TMZ) 150 mg/m\^2 once daily on days 1-7 and 15-21.
- interventionNames
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- Arm II: TMZ + Thalidomide
- description
- Temozolomide as in arm I and oral Thalidomide (Thal) once daily on days 1-28 (starting dose 200 mg).
- interventionNames
- Drug: Temozolomide
- Drug: Thalidomide
- type
- EXPERIMENTAL
- label
- Arm III: TMZ + Isotretinoin
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial glioblastoma multiforme * Must have undergone a biopsy OR subtotal or gross total resection of the tumor * Must have completed post-operative (or post-biopsy) radiotherapy within the past 5 weeks * No progressive disease after radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Serum glutamate pyruvate transaminase (SGPT) \< 2 times upper limit of normal (ULN) * Alkaline phosphatase \< 2 times ULN * Bilirubin ≤ 1.5 mg/dL Renal * blood urea nitrogen (BUN) ≤ 1.5 times ULN * Creatinine ≤ 1.5 times ULN Immunologic * No history of allergic reactions attributed to compounds of similar chemical or biological composition to celecoxib or to sulfonamides * No asthma, urticaria, or allergic reactions to aspirin or other NSAIDs * No active infection Gastrointestinal * No inflammatory bowel disease * No history of peptic ulcer disease * No gastrointestinal bleeding within past 3 months Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-method contraception during and for 2 months after study participation * Fertile female patients randomized to receive thalidomide must use effective double-method contraception for ≥ 4 weeks before, during, and ≥ 4 weeks after completion of study therapy * Fertile male patients randomized to receive thalidomide must use effective contraception during and for ≥ 4 weeks after completion of study therapy * No blood donation (for patients randomized to receive thalidomide) * No history of any other cancer except nonmelanoma skin cancer or carcinoma in situ of the cervix or cancer that is in complete remission and patient completed all therapy for that disease ≥ 3 years ago * No other disease that would obscure toxicity or dangerously alter drug metabolism (e.g., severe connective tissue disease) * No other serious medical illness PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Prior temozolomide in combination with radiotherapy allowed * No other prior or concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * See Chemotherapy Surgery * See Disease Characteristics * No concurrent surgery Other * No other concurrent non-steroidal anti-inflammatory drugs (NSAIDs) (for patients randomized to receive celecoxib) * No other concurrent investigational drugs * No other concurrent anticancer therapy
References
Publications (2)
- RESULTGilbert MR, Gonzalez J, Hunter K, Hess K, Giglio P, Chang E, Puduvalli V, Groves MD, Colman H, Conrad C, Levin V, Woo S, Mahajan A, de Groot J, Yung WK. 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 Oncol. 2010 Nov;12(11):1167-72. doi: 10.1093/neuonc/noq100. Epub 2010 Aug 20. PMID 20729242
- DERIVEDPenas-Prado M, Hess KR, Fisch MJ, Lagrone LW, Groves MD, Levin VA, De Groot JF, Puduvalli VK, Colman H, Volas-Redd G, Giglio P, Conrad CA, Salacz ME, Floyd JD, Loghin ME, Hsu SH, Gonzalez J, Chang EL, Woo SY, Mahajan A, Aldape KD, Yung WK, Gilbert MR; MD Anderson Community Clinical Oncology Program; Brain Tumor Trials Collaborative. Randomized phase II adjuvant factorial study of dose-dense temozolomide alone and in combination with isotretinoin, celecoxib, and/or thalidomide for glioblastoma. Neuro Oncol. 2015 Feb;17(2):266-73. doi: 10.1093/neuonc/nou155. Epub 2014 Sep 19. PMID 25239666