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Phase I/II Trial of Irinotecan (CPT-11) in Patients With Recurrent Malignant Glioma (NCT00003616)

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 irinotecan in treating patients who have progressive or recurrent malignant glioma.
  • Drug: irinotecan hydrochloride
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    Accepts Healthy Volunteers
    OBJECTIVES: I. Determine the maximum tolerated dose and the dose limiting toxicities of irinotecan in patients with progressive or recurrent malignant glioma. II. Define the safety profile of every 3 week dosing of irinotecan in these patients. III. Characterize the pharmacokinetic profile of this regimen in these patients. IV. Assess evidence of antitumor activity in these patients. V. Determine the efficacy of irinotecan in these patients as measured by 6 month progression-free survival and objective tumor response. VI. Evaluate further the safety profile of irinotecan in these patients during phase II study.

    OUTLINE: This is a dose escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (EIAEDs)(yes vs no). Group A (without EIAEDs): Patients receive irinotecan IV over 90 minutes on day 1, followed by up to 3 weeks of rest. Group B (with EIAEDs): Patients receive the same treatment but dose escalation is performed in cohorts of 3 patients. The maximum tolerated dose (MTD) is defined as the dose below that at which 2 of 6 patients experience dose limiting toxicities. The Phase I MTD is the starting dose recommended for use in the Phase II portion of the study. Treatment continues every 3 weeks for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, then every 6 months until disease progression. Patients are then followed every 4 months for survival.

    PROJECTED ACCRUAL: Up to 30 patients will be accrued for phase I within 10 months. A total of 48 patients will be accrued for phase II within 6-8 months.

    10 locations

    United States (10)
    • Jonsson Comprehensive Cancer Center, UCLA
      Not specified
      Los Angeles, California, United States, 90095-1781
    • UCSF Cancer Center and Cancer Research Institute
      Not specified
      San Francisco, California, United States, 94143-0128
    • Dana-Farber Cancer Institute
      Not specified
      Boston, Massachusetts, United States, 02115
    • University of Michigan Comprehensive Cancer Center
      Not specified
      Ann Arbor, Michigan, United States, 48109-0752
    • University of Pittsburgh Cancer Institute
      Not specified
      Pittsburgh, Pennsylvania, United States, 15213-3489
    • Children's Hospital of Pittsburgh
      Not specified
      Pittsburgh, Pennsylvania, United States, 15213
    • Simmons Cancer Center - Dallas
      Not specified
      Dallas, Texas, United States, 75235-9154
    • University of Texas - MD Anderson Cancer Center
      Not specified
      Houston, Texas, United States, 77030-4009
    • University of Texas Health Science Center at San Antonio
      Not specified
      San Antonio, Texas, United States, 78284-7811
    • University of Wisconsin Comprehensive Cancer Center
      Not specified
      Madison, Wisconsin, United States, 53792-6164
    Ⅰ, Ⅱ
    31 August, 1998
    12 December, 2008
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