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Phase II Evaluation of Temodal (Temozolomide, Schering) in Previously Treated Advanced Sarcomas (NCT00003718)

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have advanced soft tissue sarcoma.
  • Drug: temozolomide
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    OBJECTIVES: I. Determine the efficacy, as measured by the response rate, of temozolomide in patients with unresectable, stage IV, or recurrent soft tissue sarcoma who have failed no more than 2 prior treatment regimens. II. Determine the clinical and laboratory toxicities, as well as patient tolerance, of this regimen in this patient population.

    OUTLINE: Patients are stratified according to ECOG performance status (0-1 vs 2), prior surgery (yes vs no), prior radiotherapy (yes vs no), and prior chemotherapy regimens (0 vs 1 vs 2). Patients receive oral temozolomide every 12 hours for 5 days. Courses repeat every 4 weeks for at least 18 months in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for the first 18 months, every 6 months for the next 18 months, and then annually thereafter until death.

    PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

    1 locations

    United States (1)
    • Herbert Irving Comprehensive Cancer Center
      Not specified
      New York, New York, United States, 10032
    Status:
    unknown
    Type:
    Interventional
    Phase:
    Start:
    31 August, 1998
    Updated:
    02 January, 2014
    Participants:
    25
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