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CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality Clinical research trials and CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality. CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality clinical trial. Test subjects oftentimes recieve the best healthcare possible for their CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality  CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality
CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality
For Condition: de novo myelodysplastic syndromes,secondary myelodysplastic syndromes,previously treated myelodysplastic syndromes
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenNimer, Principal Investigator, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Stephen Nimer 212-639-7871
Additional Information:
Study ID Numbers: CDR0000343384; CELGENE-CC-5013-MDS-003,MSKCC-03085
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074126
Other Previously Treated Myelodysplastic Syndromes Studies:
1. Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
2. Daclizumab Compared With Antithymocyte Globulin in Treating Cytopenia in Patients With Myelodysplastic Syndromes
3. Thalidomide in Treating Patients With Myelodysplastic Syndrome
4. Combination Chemotherapy With or Without Bone Marrow Transplantation in Treating Children With Acute Myeloid Leukemia
5. Cholecalciferol in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other previously treated myelodysplastic syndromes Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
CC-5013 in Treating Patients With Red Blood Cell Transfusion-Dependent Myelodysplastic Syndromes and a Cytogenetic Abnormality
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