Thalidomide and Epoetin Alfa in Treating Anemia in Patients With Myelodysplastic Syndrome
Anemia, Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional supportive care trial for Anemia focused on measuring de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, previously treated myelodysplastic syndromes, anemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, myelodysplastic/myeloproliferative neoplasm, unclassifiable, childhood myelodysplastic syndromes
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of myelodysplastic syndromes Newly diagnosed OR Prior treatment was unsuccessful, including treatment with chemotherapy International prognostic scoring system score no greater than 1.5 Hemoglobin no greater than 10 g/dL (untransfused) AND/OR Received at least 3 units of packed red blood cells for symptomatic anemia within the past 6 weeks PATIENT CHARACTERISTICS: Age Over 21 Performance status Karnofsky 70-100% Life expectancy At least 6 months Hematopoietic See Disease Characteristics No prior bleeding disorder Hepatic Bilirubin less than 2 mg/dL ALT/AST less than 2 times upper limit of normal Renal Creatinine less than 1.5 mg/dL Cardiovascular No prior clinically significant heart disease No uncontrolled hypertension No recent thromboembolic disease (e.g., deep vein thrombosis) Prior thromboembolic events allowed provided event occurred at least 6 weeks prior to study and patient is on anticoagulants and is clinically stable Pulmonary No unstable pulmonary disease No recent pulmonary embolism No active pulmonary infection Neurologic No pre-existing peripheral neuropathy greater than grade 2 No sustained neurologic deficit No epilepsy Other Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 effective methods (including 1 highly effective method) of contraception for at least 4 weeks before, during, and for at least 4 weeks after study completion No active infection No concurrent illness that would obscure toxicity or dangerously alter drug metabolism No other serious concurrent medical illness No uncontrolled diabetes mellitus No other malignant disease (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off therapy for that disease for more than 1 year No known hypersensitivity to mammalian cell-derived products or human albumin PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 4-6 weeks since prior therapy
Sites / Locations
- Fallon Clinic at Worcester Medical Center
- UMASS Memorial Cancer Center - University Campus