Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I/II Trial Of Temozolomide And Carboplatin In 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.
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.
;
Primary Purpose: Treatment
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