Procarbazine in Treating Patients With Recurrent Brain Tumor
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004004|
Recruitment Status : Completed
First Posted : August 20, 2003
Last Update Posted : June 21, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: procarbazine hydrochloride||Phase 1 Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas|
|Study Start Date :||July 1999|
|Actual Study Completion Date :||August 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004004
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|United States, Georgia|
|Emory University Hospital - Atlanta|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania Cancer Center|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|Study Chair:||Stuart A. Grossman, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|