Bryostatin 1 Plus Vincristine in Treating Patients With Recurrent or Refractory HIV-Related Lymphoma

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

Summary

Phase I trial to study the effectiveness of bryostatin 1 plus vincristine in treating patients who have recurrent or refractory lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bryostatin 1 may help vincristine kill more cancer cells by making them more sensitive to the drug

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

Details

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

Criteria

Inclusion Criteria:

• Histologically confirmed B-cell lymphoma

• Eligible subtypes:

• Intermediate or high-grade non-Hodgkin's lymphoma (NHL), defined as follicular large cell, mantle cell, diffuse mixed cell, diffuse large cell and variants, Burkitt or Burkitt-like, or unclassifiable aggressive histologies

• Body cavity-based lymphoma or primary effusion lymphoma

• Evidence of HIV infection

• Received at least 1 prior systemic chemotherapy regimen with failure to respond or relapse after completion of first-line therapy, including one of the following doxorubicin-based combinations:

• Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)

• Infusional cyclophosphamide, doxorubicin, and etoposide (CDE)

• Etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH)

• Evaluable disease outside of prior radiation port

• No CNS parenchymal or leptomeningeal involvement

• No primary CNS NHL

• No HTLV-1-associated leukemia or lymphoma

• Performance status - Karnofsky 70-100%

• At least 12 weeks

• Absolute granulocyte count at least 1,000/mm3

• Platelet count at least 75,000/mm3

• Hemoglobin at least 8.0 g/dL

• Bilirubin no greater than 1.5 mg/dL (unless concurrently on indinavir)

• SGOT and SGPT less than 3 times upper limit of normal

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 50 mL/min

• No history of cardiac disease

• LVEF at least 45% by radionuclide ventriculography

• No symptomatic congestive heart failure

• No active angina pectoris

• No uncontrolled hypertension

• No history of symptomatic pulmonary disease

• Corrected DLCO more than 50% predicted

• No severe chronic obstructive lung disease

• No symptomatic restrictive lung disease

• Recurrent controllable infection (e.g., thrush) on chronic suppressive therapy allowed

• No active uncontrolled infection

• No active significant opportunistic infection (e.g., acute Pneumocystis pneumonia, cytomegalovirus retinitis on induction or maintenance therapy, acute toxoplasmosis)

• No grade 2 or greater peripheral neuropathy

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• At least 24 hours since prior transfusion

• At least 24 hours since prior colony-stimulating factor therapy

• No concurrent prophylactic filgrastim (G-CSF)

• See Disease Characteristics

• No concurrent hydroxyurea

• See Disease Characteristics

• At least 4 weeks since prior large-field radiotherapy

• At least 3 weeks since prior anticancer therapy and recovered

• Must be receiving stable antiretroviral regimen of at least 4 weeks duration