A Phase I Trial of Combination Bryostatin-1 and Vincristine in HIV-Related B-cell Neoplasms
I. Determine the maximum tolerated dose of bryostatin 1 when administered with vincristine
in patients with recurrent or refractory HIV-related B-cell lymphoma.
II. Determine the toxicity profile of this regimen in these patients. III. Determine the
objective response and survival of these patients treated with this regimen.
IV. Determine the immunomodulatory effects of this regimen on interleukin-2 (IL-2), IL-2
receptor, and IL-6 cytokine levels in these patients.
V. Determine the effect of this regimen on CD4+ lymphocyte count and HIV load in these
VI. Determine the effect of this regimen on the human herpes virus-8 load in these patients
with body cavity-based lymphoma.
OUTLINE: This is a multicenter, dose-escalation study of bryostatin 1.
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.
Cohorts of 3-6 patients receive escalating doses of bryostatin 1 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of bryostatin-1 defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
AIDS Associated Malignancies Clinical Trials Consortium
United States: Food and Drug Administration
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