NCT00087061

Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma

Oral ST1481 in Adults With Malignant Glioma: A Phase I-II Clinical Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	gimatecan

Timeline

• Start date: 2004-05-01
• Completion: 2005-06-01
• First posted: 2004-07-12
• Last updated: 2013-07-18

Locations

1 site across 1 country: United States