Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT00087061|
Recruitment Status : Completed
First Posted : July 12, 2004
Last Update Posted : July 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: gimatecan||Phase 1 Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Oral ST1481 in Adults With Malignant Glioma: A Phase I-II Clinical Trial|
|Study Start Date :||May 2004|
|Actual Study Completion Date :||June 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|