Expired Study
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New York, New York 10021


Purpose:

RATIONALE: CC-5013 may stop the growth of myelodysplastic syndrome by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of CC-5013 in treating patients who have transfusion-dependent low-risk or intermediate-risk myelodysplastic syndrome.


Study summary:

OBJECTIVES: Primary - Determine the efficacy of CC-5013, in terms of hematopoietic improvement, in patients with transfusion-dependent low- or intermediate-1-risk myelodysplastic syndromes. Secondary - Determine the safety of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral CC-5013 once daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 136 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of low- or intermediate-1-risk myelodysplastic syndromes (MDS) - No abnormality of chromosome 5 involving a deletion between bands q31 and q33 - Red blood cell (RBC) transfusion-dependent, defined as having received at least 2 units of RBCs within the past 8 weeks - No proliferative (WBC ≥ 12,000/mm^3) chronic myelomonocytic leukemia PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics - Absolute neutrophil count ≥ 500/mm^3 - Platelet count ≥ 50,000/mm^3 - No clinically significant anemia due to iron, B_12, or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding* NOTE: *If a marrow aspirate is not evaluable for storage iron, transferrin saturation must be ≥ 20% AND ferritin ≥ 50 ng/mL Hepatic - AST and ALT ≤ 3.0 times upper limit of normal - Bilirubin ≤ 2.0 mg/dL Renal - Creatinine ≤ 2.5 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior grade 3 or greater allergic reaction or hypersensitivity to thalidomide - No prior grade 3 or greater rash or any desquamation while taking thalidomide - No other malignancy within the past 3 years except basal cell or squamous cell cancer or carcinoma in situ of the cervix or breast - No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent or participating in the study - Able to aspirate bone marrow PRIOR CONCURRENT THERAPY: Biologic therapy - No prior CC-5013 - More than 7 days since prior hematopoietic growth factors - No concurrent red blood cell hematopoietic growth factors (e.g., epoetin alfa) Chemotherapy - More than 28 days since prior chemotherapy for MDS - No concurrent chemotherapy for MDS Endocrine therapy - More than 28 days since prior chronic use (more than 2 weeks) of more than physiologic doses of corticosteroids (dose equivalent to more than 10 mg/day of prednisone) - No concurrent corticosteroids except steroids for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic - No concurrent androgens Radiotherapy - Not specified Surgery - Not specified Other - More than 28 days since prior standard (i.e., immunosuppressive or cytoprotective agents) therapy for MDS - More than 28 days since prior experimental therapy - No other concurrent investigational agents


NCT ID:

NCT00077506


Primary Contact:

Study Chair
Virginia Klimek, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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