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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. Identifier: NCT00004004
Recruitment Status : Completed
First Posted : August 20, 2003
Last Update Posted : June 21, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: procarbazine hydrochloride Phase 1 Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Greater than 2 months


  • Absolute neutrophil count at least 1500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 mg/dL
  • SGPT/SGOT no greater than 4 times upper limit of normal


  • Creatinine no greater than 1.7 mg/dL


  • 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


Biologic therapy:

  • No concurrent filgrastim (G-CSF) during the first course


  • 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


  • See Disease Characteristics
  • At least 3 months since prior radiotherapy


  • Prior surgery allowed


  • 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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT00004004

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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
Sponsors and Collaborators
New Approaches to Brain Tumor Therapy Consortium
National Cancer Institute (NCI)
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Study Chair: Stuart A. Grossman, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publications of Results:
Layout table for additonal information Identifier: NCT00004004    
Other Study ID Numbers: CDR0000067214
First Posted: August 20, 2003    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: May 2007
Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Antineoplastic Agents