Bryostatin 1 Plus Vincristine in Treating Patients With Recurrent or Refractory HIV-Related Lymphoma
AIDS-related Diffuse Large Cell Lymphoma, AIDS-related Diffuse Mixed Cell Lymphoma, AIDS-related Peripheral/Systemic Lymphoma
About this trial
This is an interventional treatment trial for AIDS-related Diffuse Large Cell Lymphoma
Eligibility 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
Sites / Locations
- AIDS - Associated Malignancies Clinical Trials Consortium
Arms of the Study
Arm 1
Experimental
Treatment (bryostatin 1, vincristine sulfate)
Patients receive bryostatin 1 IV continuously on days 1 and 15 and vincristine IV over 5 minutes on days 2 and 16. Treatment continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.