Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme
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.
|Brain and Central Nervous System Tumors||Drug: carboplatin Drug: temozolomide||Phase 1 Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I/II Trial Of Temozolomide And Carboplatin In Recurrent Glioblastoma Multiforme|
|Study Completion Date:||April 2002|
|Primary Completion Date:||April 2002 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00021307
|Study Chair:||Jon Glass, MD||Fox Chase Cancer Center|