Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogeneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells. This is a multi-center, open-label, Phase II study of obatoclax administered in 2-week cycles to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Myelodysplastic Syndromes are allowed
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Stanford University
Stanford, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
James A. Haley Veterans Hospital
Tampa, Florida, United States
Emory University School of Medicine/ Winship Cancer Center
Atlanta, Georgia, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
Michigan State University, Breslin Cancer Center CTO
Lansing, Michigan, United States
Hematology-Oncology Centers of the Northern Rockies
Billings, Montana, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
...and 12 more locations
International Working Group (IWG) Response Criteria for MDS
Determine the response rate according to bone marrow blast count less than or equal to 10%
Time frame: 52 weeks
Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements
hemoglobin level less than 10 g/dL and or platelets less than 50 x 10 9/L. Eastern Cooperative Onocology Group (ECOG) performance status: 0 fully active-2 ambulatory 50% of the time; and total bilirubin less than or equal to 2 mg/dL; normal limits of SGOT/SGPT and creatinine according to laboratory standards
Time frame: 52 weeks
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