Leukemia Clinical Trial
Official title:
Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study
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.
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.
;
Primary Purpose: Treatment
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