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A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas (NCT00004004)

National Cancer Institute (NCI)
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.
  • Drug: procarbazine hydrochloride
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    10 locations

    United States (10)
    • University of Alabama at Birmingham Comprehensive Cancer Center
      Birmingham, Alabama, United States, 35294-3300
    • H. Lee Moffitt Cancer Center and Research Institute
      Tampa, Florida, United States, 33612-9497
    • Emory University Hospital - Atlanta
      Atlanta, Georgia, United States, 30322
    • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      Baltimore, Maryland, United States, 21231-2410
    • Massachusetts General Hospital Cancer Center
      Boston, Massachusetts, United States, 02114
    • Henry Ford Hospital
      Detroit, Michigan, United States, 48202
    • Comprehensive Cancer Center at Wake Forest University
      Winston-Salem, North Carolina, United States, 27157-1082
    • Cleveland Clinic Taussig Cancer Center
      Cleveland, Ohio, United States, 44195
    • University of Pennsylvania Cancer Center
      Philadelphia, Pennsylvania, United States, 19104-4283
    • University of Texas Health Science Center at San Antonio
      San Antonio, Texas, United States, 78284-7811
    Status:
    completed
    Type:
    Interventional
    Phase:
    Ⅰ, Ⅱ
    Start:
    30 June, 1999
    Updated:
    19 June, 2013
    Participants:
    0
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