Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

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

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 complete remission then as long as it is beneficial.

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