Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma
RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.
|Brain and Central Nervous System Tumors||Drug: gimatecan||Phase 1 Phase 2|
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Oral ST1481 in Adults With Malignant Glioma: A Phase I-II Clinical Trial|
|Study Start Date:||May 2004|
|Study Completion Date:||June 2005|
- Determine the maximum tolerated dose (MTD) of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs.
- Determine whether this drug has sufficient activity to warrant further development in these patients. (phase II)
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetic behaviors of this drug in these patients.
- Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients.
- Determine the antitumor activity of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients are stratified according to the concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no).
- Phase I: Patients receive oral gimatecan once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of gimatecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II: Patients receive gimatecan as in phase I at the MTD. Patients are followed for at least 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 30-83 patients (30-42 for phase I [15-21 per stratum] and 21-41 for phase II) will be accrued for this study within 24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087061
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Timothy F. Cloughesy, MD||Jonsson Comprehensive Cancer Center|