Procarbazine in Treating Patients With Recurrent Brain Tumor
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors
Intervention: procarbazine hydrochloride (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: National Cancer Institute (NCI) Official(s) and/or principal investigator(s):
Stuart A. Grossman, MD, Study Chair, Affiliation: Sidney Kimmel Comprehensive Cancer Center
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.
Clinical Details
Official title: A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas
Study design: Treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Greater than 2 months
Hematopoietic:
- Absolute neutrophil count at least 1500/mm^3
- Platelet count at least 100,000/mm^3
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
PRIOR CONCURRENT 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:
- Recovered from toxicity of prior therapy
- 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)
Locations and Contacts
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama 35294-3300, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612-9497, United States
Emory University Hospital - Atlanta, Atlanta, Georgia 30322, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland 21231-2410, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, United States
Henry Ford Hospital, Detroit, Michigan 48202, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina 27157-1082, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio 44195, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania 19104-4283, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas 78284-7811, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: July 1999
Last updated: May 23, 2008
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