Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT00087061
Brief Summary:
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.
Detailed Description:
OBJECTIVES:
Primary
* 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)
Secondary
* 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.
Study:
NCT00087061
Study Brief:
Protocol Section:
NCT00087061