Alvocidib in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of flavopiridol in treating patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as alvocidib, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of 1 of the following:

• B-cell chronic lymphocytic leukemia (CLL)

• Small lymphocytic lymphoma (SLL)

• Must have received 1-3 prior therapies for CLL

• Completed therapy 2-12 months ago

• Prior therapy must have led to a partial response or greater

• No evidence of progressive disease

• ECOG performance status 0-2

• Absolute neutrophil count ≥ 1,000/mm³

• WBC ≤ 5,000/mm³

• Platelet count ≥ 50,000/mm³

• Cytopenia allowed

• Creatinine < 2.0 mg/dL

• Bilirubin ≤ 1.5 times normal (unless due to Gilbert's disease or hemolysis)

• AST ≤ 2 times normal (unless due to hemolysis)

• No secondary malignancy or other disease that would limit survival to < 2 years

• No history of inflammatory bowel disease unless inactive for > 2 years

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• See Disease Characteristics

• No other concurrent chemotherapy

• No concurrent radiotherapy

• No concurrent dexamethasone or other corticosteroid-based antiemetics

• No concurrent chronic corticosteroid therapy

• No other concurrent hormonal therapy except for the following:

• Steroids for new adrenal failure

• Hormones for nondisease-related conditions (e.g., insulin for diabetes)