NCT00045708

A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas

A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-grade Gliomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. This phase I/II trial is studying the side effects and best dose of ixabepilone and how well it works in treating patients with recurrent glioma.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose of BMS-247550 when administered to adults with recurrent malignant gliomas, receiving (Group A) or not receiving (Group B) anticonvulsants known to be metabolized by the P450 hepatic enzyme complex. II. To describe the pharmacokinetics of this route of administration, measuring BMS-247550, and determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the pharmacokinetics. III. To determine the response rate of adult patients with recurrent glioma to BMS-247550 administered at the MTD. IV. To describe the toxicity associated with this regimen in adult patients with recurrent malignant gliomas. SECONDARY OBJECTIVES: I. To determine the percent of patients with 6 month progression free survival, duration of progression free survival and survival associated with this therapy in adult patients with recurrent malignant gliomas. OUTLINE: This is a phase I, dose-escalation, multicenter study followed by a phase II, safety and efficacy, multicenter study. For phase I only, patients are stratified according to cytochrome P450-inducing anticonvulsant use (yes vs no). Phase I: Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose-limiting toxicity. Phase II: Once the MTD is determined, additional patients receive ixabepilone as above at the MTD. Patients are followed every 2 months. PROJECTED ACCRUAL: A minimum of 10-15 patients will be accrued for the phase I portion of this study. A total of 22-33 patients will be accrued for the phase II portion of this study within 4-6 months.

Conditions

• Adult Anaplastic Astrocytoma
• Adult Giant Cell Glioblastoma
• Adult Gliosarcoma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
DRUG	ixabepilone	Given IV
OTHER	pharmacological study	Correlative studies
DRUG	Anticonvulsant	Drugs that induce hepatic Metabolic enzymes

Timeline

• Start date: 2002-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2003-01-27
• Last updated: 2017-10-18
• Results posted: 2017-05-09

Locations

5 sites across 1 country: United States