Leukemia Clinical Trial
Official title:
Phase I/II Study of Combined Treatment With Amifostine (Ethyol) and Topotecan (Hycamtin MS) in Patients With Myelodysplastic Syndrome
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal
cells from the side effects of chemotherapy.
PURPOSE: Phase I/II trial to study the effectiveness of amifostine plus topotecan in
treating patients with myelodysplastic syndrome.
OBJECTIVES: I. Evaluate the hematologic and cytogenetic response to treatment with
amifostine plus topotecan in patients with myelodysplastic syndromes. II. Evaluate the toxic
effects of this treatment in these patients. III. Evaluate the effects of this treatment on
bone marrow recovery in these patients.
OUTLINE: This is a dose escalation study of topotecan. Patients receive amifostine IV
followed by topotecan IV over 30 minutes on days 1-5 every 4-8 weeks for at least two
courses. Patients who are responding after two courses of induction receive maintenance
courses every 6-8 weeks for up to ten courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level of topotecan.
The maximum tolerated dose is defined as the dose at which no more than 2 of 6 patients
experience dose limiting toxicity.
PROJECTED ACCRUAL: A maximum of 26 patients will be accrued for this study.
;
Primary Purpose: Treatment
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