Clinical trial · Interventional
Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy
A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme
NCT00039468CI-TRIAL-00005693completedPhase 2ClinicalTrials.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: Thalidomide may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with irinotecan may kill any tumor cells remaining after radiation therapy. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response
- timeFrame
- 2 years
- description
- To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.
Secondary outcomes (1)
- measure
- Toxicity / QOL / Survival
- timeFrame
- 2 years
- description
- To evaluate 1) toxicity 2) quality of life 3) disease free survival and 4) overall survival of patients treated with this combination.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme (GBM) * Recurrent disease allowed * Evaluable disease on contrast-enhanced MRI * Prior external beam radiotherapy required PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST or ALT no greater than 5 times ULN Renal: * Creatinine no greater than 1.5 times ULN OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No significant cardiac disease * No uncontrolled high blood pressure * No unstable angina * No congestive heart failure * No myocardial infarction within the past 3 months * No serious cardiac arrhythmias Gastrointestinal: * Able to take oral medication * No gastrointestinal abnormalities * No requirement for IV alimentation * No active peptic ulcer disease Other: * No active infection * No serious uncontrolled medical disorder * No dementia or significantly altered mental status that would preclude study * No known hypersensitivity to irinotecan or thalidomide * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior thalidomide Chemotherapy: * No prior irinotecan * At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse) Endocrine therapy: * Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study * No concurrent hormonal therapy for GBM Radiotherapy: * See Disease Characteristics * No concurrent radiotherapy for GBM Surgery: * No prior surgical procedures affecting absorption Other: * No other concurrent anticancer investigational agents for GBM * No concurrent cytochrome P450 inhibitors, including the following: * Nefazodone * Fluvoxamine * Fluoxetine * Sertraline * Paroxetine * Venlafaxine * Ketoconazole * Itraconazole * Fluconazole * Cimetadine * Clarithromycin * Diltiazem * Erythromycin * Protease inhibitors
References
Publications (1)
- RESULTFadul CE, Kingman LS, Meyer LP, Cole BF, Eskey CJ, Rhodes CH, Roberts DW, Newton HB, Pipas JM. A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme. J Neurooncol. 2008 Nov;90(2):229-35. doi: 10.1007/s11060-008-9655-9. Epub 2008 Jul 26. PMID 18661102