Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
B-cell Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia
About this trial
This is an interventional treatment trial for B-cell Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria: Diagnosis of B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma, including Waldenstrom's macroglobulinemia, as indicated by the following: Massive or progressive splenomegaly and/or lymphadenopathy Anemia (hemoglobin less than 11 g/dL) or thrombocytopenia (platelet count less than 100,000/mm^3) Weight loss of more than 10% within the past 6 months Grade 2 or 3 fatigue Fevers greater than 100.5º C or night sweats for more than 2 weeks with no evidence of infection Progressive lymphocytosis with an increase of more than 50% over a 2-month period or anticipated doubling time of less than 6 months Received at least 1 prior therapy for CLL Performance status - ECOG (Eastern Cooperative Oncology Group) 0-2 See Disease Characteristics WBC (white blood count) less than 200,000/mm^3 Bilirubin no greater than 1.5 times normal (unless due to Gilbert's disease or any of the conditions stated below)* AST (aspartate aminotransferase) no greater than 2 times normal* Creatinine no greater than 2.0 mg/dL Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy that would limit survival to less than 2 years No history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) unless inactive for more than 2 years No psychiatric condition that would preclude compliance with treatment or giving informed consent No other concurrent chemotherapy No concurrent chronic corticosteroids No concurrent hormonal therapy except steroids for new adrenal failure or hormonal agents for nondisease-related conditions (e.g., insulin for diabetes) No concurrent dexamethasone or other corticosteroid-based antiemetics No concurrent radiotherapy
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive a loading dose of flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of unacceptable toxicity or disease progression.