Status:
COMPLETED
8-Chloro-Adenosine in Chronic Lymphocytic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
FDA Office of Orphan Products Development
Conditions:
Leukemia
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest safe dose of the drug 8-chloro-adenosine that can be given in the treatment of chronic lymphocytic leukemia (CLL). Another goal is to le...
Detailed Description
8-Chloro-adenosine is a new drug similar to other drugs already approved by the FDA for the treatment of CLL and other types of cancer. 8-Chloro-adenosine belongs to a class of chemotherapy drugs call...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of chronic lymphocytic leukemia and must be previously treated with at least one prior treatment regimen, including a purine-analogue based treatment.
- Patients must be Rai Stage III or IV OR Rai Stage 0-II and have one or more criteria for active disease as defined by the NCI-Working Group as: a) weight loss of more than 10% in the last 6 months; b) fatigue; c) fever or night sweats without evidence of infection; d) progressive anemia or thrombocytopenia; e) progressive lymphocytosis with a lymphocyte doubling time \</= 6 months; or f) marked hypogammaglobulinemia or paraproteinemia.
- All patients must have a Zubrod performance status of \</= 2.
- All patients must be age \>/= 18 years.
- Patients may not receive concurrent treatment for their CLL and must have been off treatment (chemotherapy, immunotherapy, or radiotherapy) for 4 weeks prior to treatment on this study and recovered from toxic effects of that therapy.
- All patients must have adequate renal function indicated by serum creatinine \</=2.5x upper limits of normal (ULN) and adequate liver function indicated by ALT or AST \</= 2.5x ULN AND total bilirubin \</= 2.5x ULN.
- All patients must have a pre-treatment platelet count of \>/= 50,000 /µl and not require transfusion to maintain this platelet count unless thrombocytopenia is due to marrow infiltrated with disease.
- All patients or appropriate surrogate must provide informed consent.
Exclusion
- Patients with active uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia purpura.
- Patients with active uncontrolled fungal, bacterial, or viral infection.
- Patients who are pregnant or breast-feeding.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00714103
Start Date
June 1 2008
End Date
October 1 2016
Last Update
October 13 2016
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030