Status:
COMPLETED
Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia
Lead Sponsor:
University of Arkansas
Collaborating Sponsors:
Celgene Corporation
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.
Detailed Description
Patients will take Thalidomide tablets at bedtime daily until remission. The dose will be increased gradually and modified according to side-effects. The drug will be given daily up to the time of com...
Eligibility Criteria
Inclusion
- Diagnosis of refractory or relapsed leukemia: acute leukemia, CML, CLLm and MDS.
- Signed informed consent, including patient agreeing to use safe contraceptive methods during the treatment and for at least 4 months after the treatment is completed
- Serum creatinine \< or = 2.5mg/dL
- Serum bilirubin\< or = 2.5mg/dL
- Negative pregnancy test
- Age 18 years or older
- Performance status \< or = 3
Exclusion
- Pregnant or lactating women
- Concurrent treatment with cytotoxic chemotherapy, or radiation
- History of seizures, neurotoxicity, or active CNS disease
- Serious infections not controlled by antibiotics
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00083694
Start Date
August 1 1998
End Date
May 1 2005
Last Update
July 2 2010
Active Locations (1)
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1
University of Arkansas for Medical Sciences/MIRT
Little Rock, Arkansas, United States, 72205