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Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme



Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme

For Condition: recurrent adult brain tumor,adult glioblastoma multiforme
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Fox Chase Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus carboplatin in treating patients who have recurrent glioblastoma multiforme.
Details: OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of temozolomide and carboplatin in patients with recurrent glioblastoma multiforme. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the potential of either a pharmacokinetic or pharmacodynamic-mediated drug interaction in patients treated with this regimen. V. Determine the objective response rate and stabilization rate in patients treated with this regimen at the MTD. VI. Determine the acute and long-term toxic effects of this regimen at the MTD in these patients. VII. Determine the time to tumor progression and survival of patients treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation study. Patients are stratified according to age (under 50 vs 50 and over), ECOG performance status (0 vs 1-2), and prior therapy with carmustine or lomustine (yes vs no). Patients receive carboplatin IV over 30 minutes on day 1 and oral temozolomide on days 1-5. Treatment repeats every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responsive disease may receive 6 additional courses of temozolomide. Cohorts of 1-6 patients receive escalating doses of carboplatin and temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD. PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for phase I of this study. A total of 16-58 patients will be accrued for phase II of this study.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent glioblastoma multiforme - Measurable disease --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent sargramostim (GM-CSF); No concurrent prophylactic filgrastim (G-CSF) - Chemotherapy: No prior temozolomide; No prior platinum-based chemotherapy - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Recovered from prior major surgery; No more than 2 weeks since prior subtotal tumor resection - Other: Recovered from prior therapy; No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Granulocyte count greater than 1,500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin at least 10.0 g/dL - Hepatic: Bilirubin no greater than 1.5 times normal; SGOT no greater than 3 times upper limit of normal - Renal: Creatinine clearance greater than 50 mL/min - Cardiovascular: No myocardial infarction within the past 6 months; No congestive heart failure requiring therapy - Other: HIV negative; No active or uncontrolled infection; No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; No frequent vomiting; No medical condition that would interfere with oral medication intake (e.g., partial bowel obstruction); No known or suspected psychiatric disorder that would preclude study; No other severe concurrent disease that would preclude; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for at least 3 months after study
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JonGlass,  Study Chair,  Fox Chase Cancer Center


Additional Information:
Study ID Numbers:  CDR0000068768;  NCI-G01-1981,FCCC-01004
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021307

Other Adult Glioblastoma Multiforme Studies:
1. BMS 247550 in Treating Patients With Recurrent Glioma

2. Gene Therapy in Treating Patients With Recurrent or Progressive Glioblastoma Multiforme

3. Radiation Therapy and Tamoxifen in Treating Adults With Newly Diagnosed Supratentorial Glioblastoma Multiforme

4. Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma

5. Erlotinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme

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