A Phase II Study on the Effectiveness of Thalomid (Thalidomide) Combined With Procrit (Erythropoietin) for the Treatment of Anemia in Patients With Low and Intermediate Risk-1 (IPSS Score Less Than or Equal to 1.5) Myelodysplastic Syndromes
- Determine whether the combination of epoetin alfa and thalidomide improves the anemia
and/or decreases the need for red cell transfusion in patients with low- or
intermediate-risk myelodysplastic syndromes.
- Determine whether this regimen improves the bone marrow morphology and cytogenetics,
alters the natural history of the disease, and reduces the frequency of leukemic
transformation in these patients.
- Evaluate whether this regimen improves pathophysiologic parameters (e.g., apoptosis,
tumor necrosis factor-alpha concentration, microvessel density, vascular endothelial
growth factor, and cytotoxic T lymphocytes) in the bone marrow of these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients receive epoetin alfa subcutaneously (SC) once weekly for 8 weeks. After 8
weeks, patients unresponsive to epoetin alfa alone receive oral thalidomide once daily in
addition to epoetin alfa SC once weekly for a maximum of 24 weeks in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within 2 years..
Masking: Open Label, Primary Purpose: Supportive Care
Laszlo Leb, MD
United States: Federal Government
|UMASS Memorial Cancer Center - University Campus||Worcester, Massachusetts 01605-2982|
|Fallon Clinic at Worcester Medical Center||Worcester, Massachusetts 01608|