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Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study (NCT00003827)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome.
  • Drug: amifostine trihydrate
    • Drug: cytarabine
      • Drug: topotecan hydrochloride
        Ages eligible for Study
        16 Years and older
        Genders eligible for Study
        All
        Accepts Healthy Volunteers
        No
        OBJECTIVES:

        - Determine the toxic effects of amifostine, topotecan, and cytarabine in patients with poor risk myelodysplastic syndrome.

        - Determine the hematologic response rate, cytogenetic response rate, and the rate of polyclonal hematopoiesis following this treatment regimen.

        - Determine the duration of response and time to disease progression following this treatment regimen in these patients.

        OUTLINE: Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2 hours, on days 1-5. Patients receive amifostine IV over 15 minutes every other day for a maximum of 60 days. Patients may receive a second course of the same regimen 8 weeks after the first.

        Patients are followed at least monthly for 2 years, then every 3-6 months until death.

        PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study within 1 to 1.5 years.

        1 locations

        United States (1)
        • Cancer Center and Beckman Research Institute, City of Hope
          Duarte, California, United States, 91010-3000
        Status:
        unknown
        Type:
        Interventional
        Phase:
        Start:
        31 December, 1998
        Updated:
        02 December, 2013
        Participants:
        25
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