Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Arkansas
• Collaborator: Celgene Corporation
• Treatments: Thalidomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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