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

Completed · Phase 1

Conditions studied: AIDS-related Diffuse Large Cell Lymphoma, AIDS-related Diffuse Mixed Cell Lymphoma, AIDS-related Peripheral/Systemic Lymphoma, AIDS-related Small Noncleaved Cell Lymphoma

In brief

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

Key facts

Study ID

NCT00022555

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2001-11-01

Last updated by the study team

2013-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• AIDS - Associated Malignancies Clinical Trials Consortium — Rockville, Maryland, United States

Full record on ClinicalTrials.gov

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