Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer
This randomized phase II trial is studying thalidomide and fludarabine to see how well they work compared to thalidomide alone in treating patients with hematologic cancer that has not responded to previous treatment with fludarabine. Thalidomide may stop the growth of hematologic cancer by stopping blood flow to the cancer. Combining thalidomide with fludarabine may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drug. It is not yet known whether thalidomide is more effective with or without fludarabine for hematologic cancer.
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Drug: fludarabine phosphate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Study of Thalidomide Versus Thalidomide Plus Fludarabine for Patients With Chronic Lymphocytic Leukemia Previously Treated With Fludarabine|
- Toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
- Incidence of complete and partial remission [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2002|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
Experimental: Arm I (thalidomide)
Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (thalidomide, fludarabine phosphate)
Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days 1-5. Treatment with fludarabine repeats every 28 days for 6 courses. Once fludarabine is completed, patients continue to receive thalidomide alone as in arm I.
Drug: fludarabine phosphate
Other Names:Drug: thalidomide
I. Compare the safety and tolerability of thalidomide with or without fludarabine in patients with fludarabine-refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
II. Compare the incidence of complete and partial remission in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are stratified according to time to relapse from last fludarabine treatment (less than 6 months vs more than 6 months). Patients are randomized to one of two treatment arms.
Arm I: Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive thalidomide as in arm I and fludarabine IV over 30 minutes on days 1-5. Treatment with fludarabine repeats every 28 days for 6 courses. Once fludarabine is completed, patients continue to receive thalidomide alone as in arm I.
PROJECTED ACCRUAL: A total of 24-70 patients (12-35 per treatment arm) will be accrued for this study within 1 year.
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467-2490|
|Principal Investigator:||Richard Furman||Montefiore Medical Center|