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Home > "P" Clinical Trials Conditions > Procarbazine in Treating Patients With Recurrent Brain Tumor  Procarbazine in Treating Patients With Recurrent Brain Tumor
Procarbazine in Treating Patients With Recurrent Brain Tumor
For Condition: Glioblastoma,Oligodendroglioma,Brain Tumor,Astrocytoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Sidney Kimmel Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. 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. II. Determine the pharmacokinetics of oral procarbazine, including any effects of hepatic enzyme inducing drugs, in these patients. III. Assess the response rate to procarbazine in these patients. IV. Evaluate this regimen in terms of overall survival and duration of disease free survival in these patients. V. Evaluate the toxicity of this regimen in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven malignant glioma of one of the following types: Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme - Progressive or recurrent disease after radiotherapy with or without chemotherapy - Measurable disease by serial MR or CT --Prior/Concurrent Therapy-- - Recovered from toxicity of prior therapy - Biologic therapy: No concurrent filgrastim (G-CSF) during the first course - Chemotherapy: See Disease Characteristics No more than 1 prior chemotherapy regimen At least 3 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas) No more than 2 prior courses of carmustine or lomustine and no greater than 460 mg/m2 or 220 mg/m2, respectively No prior procarbazine - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy - Surgery: Prior surgery allowed - Other: At least 10 days since prior anticonvulsants for patients in Arm II No concurrent investigational agents No concurrent ethanol, ephedrine, isoproterenol, epinephrine, tricyclic antidepressants, paragyliline, narcotic analgesics, antihistamines, phenothiazines, hypotensives, or barbiturates At least 14 days since prior antidepressants (e.g., SSRI and/or MAO inhibitor) Must avoid foods high in tyramine (i.e., dark beer, wine, yogurt, cheese, bananas) --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Greater than 2 months - Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT/SGOT no greater than 4 times upper limit of normal - Renal: Creatinine no greater than 1.7 mg/dL - Other: No serious concurrent infection No other illness that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StuartGrossman, Study Chair, Sidney Kimmel Cancer Center
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Additional Information:
Study ID Numbers: CDR0000067214; JHOC-NABTT-9901,NABTT-9901
Study Start Date: July 1999
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004004
Other Astrocytoma Studies:
1. A Study of Motexafin Gadolinium and Temozolomide for the Treatment of Malignant Gliomas
2. STI571 to Treat Malignant Brain Tumors
3. Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
4. Investigating the Use of Talampanel in Patients with Recurrent High-Grade Gliomas
5. Safety and effectiveness study of G207, a tumor-killing virus, in patients with recurrent brain cancer
Related Studies:
Other Astrocytoma Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
Procarbazine in Treating Patients With Recurrent Brain Tumor
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