Myelodysplastic Syndrome Clinical Trial
Thalidomide and Epoetin Alfa in Treating Anemia in Patients With Myelodysplastic Syndrome
Summary
RATIONALE: Thalidomide may stop or slow the growth of cancer cells. Epoetin alfa may stimulate red blood cell production. Combining thalidomide with epoetin alfa may improve anemia, decrease the need for blood transfusions, and improve the quality of life in patients with myelodysplastic syndrome.
PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with epoetin alfa in treating anemia in patients who have myelodysplastic syndrome.
Full Description
OBJECTIVES:
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..
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
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There are 2 Locations for this study
Worcester Massachusetts, 01608, United States
Worcester Massachusetts, 01655, United States
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