Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004004
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
Procarbazine in Treating Patients With Recurrent Brain Tumor
Sponsor:
New Approaches to Brain Tumor Therapy Consortium
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III 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 III 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 III 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| JHOC-NABTT-9901 | None | None | None |
| NABTT-9901 | None | None | None |