Thalidomide With or Without Fludarabine in Treating Patients With Hematologic Cancer
Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for Recurrent Small Lymphocytic Lymphoma
Eligibility Criteria
Inclusion Criteria: Diagnosis of one of the following: Confirmed chronic lymphocytic leukemia (CLL), meeting the following criteria: Peripheral blood lymphocytosis greater than 5,000/mm^3 Co-expression of the CD5, CD19, CD20, and CD23 surface antigens Clonal kappa and lambda light chain expression Dim surface immunoglobulin expression Small lymphocytic lymphoma Relapsed or refractory disease Must have received at least 1 prior regimen containing fludarabine Meets one of the following criteria: Recurrence of lymphocytosis greater than 5,000/mm^3 or an increase in lymph node volume greater than 50% after achieving complete (CR) or partial response (PR) Never achieved a CR or PR after receiving at least 2 courses of fludarabine IV for 5 days at a dose of 25 mg/m^2/day No other lymphoproliferative diseases or diseases due to transformation of CLL (e.g., prolymphocytic leukemia or Richter's syndrome) No known CNS disease Performance status - Karnofsky 60-100% At least 12 weeks See Disease Characteristics Bilirubin < 2.0 times upper limit of normal (ULN)* SGOT < 2.5 times ULN* Creatinine < 1.5 times ULN No history of cardiac arrhythmia No myocardial infarction within the past 6 months No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No active serious infection uncontrolled by antibiotics No pre-existing neurotoxicity grade 3 or greater No other medical condition that would preclude study participation Not pregnant or nursing Negative pregnancy test Female patients must use 2 effective methods (at least 1 highly active method) of contraception 4 weeks before, during, and for 4 weeks after study participation and male patients must use effective barrier contraception during and for 4 weeks after study participation At least 4 weeks since prior biologic therapy and recovered No concurrent growth factors (epoetin alfa, filgrastim [G-CSF], or sargramostim [GM-CSF]) See Disease Characteristics No more than 3 prior chemotherapy regimens At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No other concurrent chemotherapy At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Recovered from any prior investigational agents No other concurrent investigational agents
Sites / Locations
- Montefiore Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (thalidomide)
Arm II (thalidomide, fludarabine phosphate)
Patients receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.
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.