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First Line Chemotherapy With Temozolomide in Recurrent Oligodendroglial Tumors, a Phase II Trial (NCT00003731)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients with recurrent oligodendroglial tumors.
  • Drug: temozolomide
    Ages eligible for Study
    18 Years to 70 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Assess the therapeutic activity of temozolomide as first line chemotherapy in patients with recurrent oligodendroglial tumors after radiation therapy. II. Assess the objective response and duration of response of these patients given this treatment. III. Characterize the acute side effects of temozolomide in this patient population.

    OUTLINE: This is an open label, multicenter study. Patients receive oral temozolomide on days 1-5. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until disease progression.

    PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study.

    24 locations

    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    30 November, 1998
    Updated:
    19 September, 2012
    Participants:
    39
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