Flavopiridol in Treating Patients With Previously Treated Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II trial studies the side effects and best dose of flavopiridol in treating patients with previously treated chronic lymphocytic leukemia or lymphocytic lymphoma. Drugs used in chemotherapy such as flavopiridol work in different ways to stop cancer cells from dividing so they stop growing or die.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib

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