Phase I/II Study of Combined Treatment With Amifostine (Ethyol) and Topotecan (Hycamtin MS) in 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
Alan F. List, MD
University of Arizona
United States: Federal Government
|Arizona Cancer Center||Tucson, Arizona 85724|