Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-28 @ 2:36 AM
Study NCT ID:
NCT00004004
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Procarbazine in Treating Patients With Recurrent Brain Tumor
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
Study Overview
Official Title:
A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: