NCT00004004

Procarbazine in Treating Patients With Recurrent Brain Tumor

A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: New Approaches to Brain Tumor Therapy Consortium · Academic / Other
• 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/II trial to study the effectiveness of procarbazine in treating patients who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme following treatment with radiation therapy.

Detailed description

OBJECTIVES: * Determine the maximum tolerated dose of oral procarbazine when administered to patients with recurrent glioma receiving or not receiving anticonvulsants metabolized by the P450 hepatic enzyme complex. * Determine the pharmacokinetics of oral procarbazine, including any effects of hepatic enzyme inducing drugs, in these patients. * Assess the response rate to procarbazine in these patients. * Evaluate this regimen in terms of overall survival and duration of disease free survival in these patients. * Evaluate the toxicity of this regimen in these patients. OUTLINE: Phase I of this study is a dose escalation study. Patients are stratified according to concurrent use of anticonvulsant drugs that induce cytochrome P450 (yes vs no drugs or modest-induction drugs). * Phase I: Patients receive oral procarbazine once daily for 5 days. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of oral procarbazine until the maximum tolerated dose (MTD) is determined. * Phase II: Once the MTD is determined, patients receive procarbazine as in Phase I. Patients are followed every 2 months until death. PROJECTED ACCRUAL: A total of 24-35 patients will be accrued for this study.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	procarbazine hydrochloride

Timeline

• Start date: 1999-07-01
• Completion: 2003-08-01
• First posted: 2003-08-20
• Last updated: 2013-06-21

Locations

10 sites across 1 country: United States