Expired Study
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Wilmington, North Carolina 28412


Purpose:

RATIONALE: Thalidomide may be an effective treatment for anemia caused by myelodysplastic syndrome. PURPOSE: Randomized phase II trial to study the effectiveness of thalidomide in treating anemia in patients who have myelodysplastic syndrome.


Study summary:

OBJECTIVES: - Determine the efficacy of thalidomide for the treatment of anemia in patients with myelodysplastic syndromes. - Determine whether this drug reduces the frequency of leukemia transformation and decreases bone marrow blast percentage in these patients. - Determine the effect of this drug on neutrophil and platelet production and the number of episodes of febrile neutropenia in these patients. - Determine the safety of this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to International Prognostic Scoring System score (low and intermediate-1 vs intermediate-2 and high) and transfusion dependence (yes vs no). Patients are randomized to one of two treatment arms. - Arm I: Patients receive oral thalidomide once daily on weeks 1-24. - Arm II: Patients receive oral placebo once daily on weeks 1-24. In both arms, patients who have not progressed to leukemia after 24 weeks of therapy may receive open-label thalidomide for an additional 24 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of myelodysplastic syndromes (MDS) of at least 12 weeks duration - Refractory anemia (RA) - RA with ringed sideroblasts - RA with excess blasts - Chronic myelomonocytic - No therapy-related MDS - No myelosclerosis or myelofibrosis occupying more than 30% of marrow space (or assessed as grade 3+ or greater) - No transformation to acute myeloid leukemia - No more than 20% blasts in bone marrow - No more than 5% blasts in peripheral blood - Patients with an erythropoietin level 100 mU/mL or less must have failed epoetin alfa treatment (i.e., at least 30,000 units of epoetin alfa weekly for at least 6 weeks) - Transfusion-dependent (received at least 2 units of packed RBCs or whole blood within the past 8 weeks) OR - Transfusion-independent (no packed RBC or whole blood transfusions within the past 8 weeks with 2 hemoglobin levels (at least 7 days apart) less than 11 g/dL) - No iron deficiency (e.g., absent bone marrow iron store) - If marrow aspirate is not evaluable, transferrin saturation must be at least 20% and ferritin at least 50 ng/mL - No uncorrected B12 or folate deficiency - No other contributing causes of anemia (e.g., autoimmune or hereditary hemolytic disorders or gastrointestinal blood loss) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Zubrod 0-2 Life expectancy: - At least 6 months Hematopoietic: - See Disease Characteristics - Absolute neutrophil count at least 500/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - AST and ALT less than 2 times upper limit of normal (ULN) - Hepatitis B surface antigen negative - Hepatitis C negative Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No uncontrolled hypertension - No clinically significant, symptomatic, unstable cardiovascular disease unrelated to MDS Pulmonary: - No clinically significant, symptomatic, unstable pulmonary disease unrelated to MDS Neurologic: - No clinically significant, symptomatic, unstable neurologic disease unrelated to MDS - No history of epilepsy - No sustained neurologic deficit (e.g., stroke) - No grade 2 or greater peripheral neuropathy Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception for 4 weeks prior to, during, and for 4 weeks after study participation - HIV negative - No clinically significant, symptomatic, unstable endocrine, gastrointestinal, or genitourinary disease unrelated to MDS - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No life-threatening or active infection requiring parenteral antibiotics - No other serious concurrent illness PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - More than 7 days since prior hematopoietic growth factors (e.g., epoetin alfa, filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-3) - No prior thalidomide - No prior agents intended to inhibit vascular endothelial growth factor or tumor necrosis factor alfa (e.g., etanercept or infliximab) - No concurrent epoetin alfa Chemotherapy: - No concurrent chemotherapy that may be active against MDS Endocrine therapy: - More than 30 days since prior androgens - No requirement for ongoing therapy with systemic corticosteroids Radiotherapy: - Not specified Surgery: - Not specified Other: - More than 30 days since prior treatment for MDS except RBC transfusion or epoetin alfa - More than 30 days since prior participation in another experimental clinical trial - More than 30 days since prior experimental drugs - No other concurrent investigational agents or treatments


NCT ID:

NCT00030550


Primary Contact:

Study Chair
James L. Slack, MD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Wilmington, North Carolina 28412
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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