NCT00014521

Karenitecin in Treating Patients With Recurrent Malignant Glioma

Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of karenitecin in treating patients who have recurrent malignant glioma.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of karenitecin in patients with recurrent malignant glioma who are receiving or not receiving anticonvulsants known to be metabolized by the P450 hepatic enzyme complex. * Determine the pharmacokinetics of this drug in these patients. * Assess the preliminary evidence of therapeutic activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex (yes vs no). Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual reassessment method until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose associated with a dose-limiting toxicity rate of 33%. Patients are followed every 2 months. PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study within 1 year.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	karenitecin

Timeline

• Start date: 2002-01-01
• First posted: 2003-01-27
• Last updated: 2008-07-24

Locations

8 sites across 1 country: United States