Expired Study
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New York, New York 10021


Purpose:

RATIONALE: CC-5013 may slow the progression of myelodysplasia and allow the body to produce normal red blood cells. PURPOSE: Phase II trial to study the effectiveness of CC-5013 in treating patients who require red blood cell transfusions for anemia caused by myelodysplastic syndrome associated with a cytogenetic abnormality.


Study summary:

OBJECTIVES: Primary - Determine the efficacy of CC-5013, in terms of hematological improvement, in patients with red blood cell transfusion-dependent low- or intermediate-risk myelodysplastic syndromes and a del(5)(q31q33) cytogenetic abnormality. Secondary - Determine the safety of this drug in these patients. OUTLINE: This is an open-label, multicenter study. Patients receive oral CC-5013 on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of low- or intermediate-risk myelodysplastic syndromes (MDS) associated with a del(5)(q31q33) cytogenetic abnormality - Cytogenetic abnormality may be an isolated cytogenetic finding (the 5q- syndrome) OR may be associated with other cytogenetic abnormalities - Red blood cell (RBC) transfusion-dependent anemia defined as having received at least 2 units of RBCs within the past 8 weeks PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 500/mm^3 - Platelet count at least 50,000/mm^3 - No clinically significant anemia due to iron, B_12, or folate deficiency, autoimmune or hereditary hemolysis, or gastrointestinal bleeding - If marrow aspirate not evaluable for storage iron, the following criteria must be met: - Transferrin saturation at least 20% - Serum ferritin at least 50 ng/mL Hepatic - Bilirubin no greater than 2.0 mg/dL - AST and ALT no greater than 3.0 times upper limit of normal Renal - Creatinine no greater than 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 (blistering) from thalidomide - No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study participation or giving informed consent or confound study results - No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast PRIOR CONCURRENT THERAPY: Biologic therapy - No prior CC-5013 - More than 7 days since prior hematopoietic growth factors - No concurrent epoetin alfa for MDS Chemotherapy - More than 28 days since prior experimental or standard chemotherapy for MDS - No concurrent chemotherapy for MDS Endocrine therapy - More than 28 days since prior chronic use (greater than 2 weeks in duration) of more than physiologic doses of corticosteroids - No concurrent androgens for MDS Radiotherapy - Not specified Surgery - Not specified Other - More than 28 days since prior experimental or standard immunosuppressive or cytoprotective agents for MDS - More than 28 days since other prior experimental or standard drugs or therapy for MDS - No other concurrent investigational agents for MDS


NCT ID:

NCT00074126


Primary Contact:

Principal Investigator
Stephen D. Nimer, 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 10, 2017

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