Bryostatin and Vincristine in B-Cell Malignancies

• Status: Completed
• 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 bryostatin-1 when given together with vincristine in treating patients with chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or multiple myeloma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Bryostatin 1; Vincristine

Criteria

Inclusion Criteria:

• Patients with biopsy proven B-cell malignancies [e.g. chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), multiple myeloma (MM)]; HIV-associated lymphomas and acute leukemias are not eligible

• Performance status: ECOG 0, 1, or 2

• Life expectancy of at least 12 weeks

• Patients with aggressive NHL will be enrolled after having failed all possible therapy with curative intent

• Patients with CLL must have failed an alkylating agent-containing regimen as well as fludarabine chemotherapy

• Patients with multiple myeloma must have received at least one prior chemotherapy regimen and not be eligible for a dose intensification treatment approach

• At least 4 weeks must have elapsed since prior large-field radiation therapy

• Patients must have been off previous anti-cancer therapy for at least 3 weeks (6 weeks for BCNU and mitomycin C) and recovered from all treatment related toxicity

• Prior vincristine therapy is allowed

• Sexually active men and women must use an accepted and effective method of contraception

• In women of child-bearing age, a pregnancy test may be done at the discretion of the investigator

• Must have given written informed consent

Exclusion Criteria:

• Patients with brain metastasis, leptomeningeal involvement, primary CNS NHL, and acute leukemia are ineligible

• Patients with HIV infection are ineligible

• WBC < 3000/ul

• Granulocytes < 1500/ul

• Platelets < 50,000/ul

• Hemoglobin =< 8.5 g/dl

• Bilirubin > 1.5 mg/dl

• AST and ALT > 2 times normal

• Creatinine > 2.0 mg/dl, and/or actual creatinine clearance < 40 ml/min/1.73 m^2; all patients are required to have a 24 hr creatinine clearance

• Clinical evidence of bleeding diathesis

• ECOG Performance status 3 or 4

• Patients who are pregnant or lactating; vincristine can cause fetal harm

• Patients with clinically apparent neuropathy are ineligible (>= grade 2 neuropathy)