Lymphoma Clinical Trial
Official title:
A Phase lb Trial of the Combination of Bryostatin-1 and Low Dose Interleukin-2: Evaluation of the Functional and Molecular Status of Human Monocytes as Antigen Presenting Cells
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to
kill cancer cells. Combining chemotherapy and interleukin-2 may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-2 when
given together with bryostatin 1 in treating patients with refractory solid tumors or
lymphoma.
OBJECTIVES:
- Determine the safety and side effects of bryostatin 1 and interleukin-2 in patients
with refractory solid tumors or lymphomas.
- Determine the maximum tolerated dose for interleukin-2 with bryostatin 1 in these
patients.
- Determine whether bryostatin 1 and interleukin-2 increase the expression of recognition
and costimulatory molecules on human monocytes and their ability to act as antigen
presenting cells.
- Assess any anti-tumor response in these patients treated with this regimen.
OUTLINE: This is a dose escalation study of interleukin-2.
Patients receive bryostatin 1 IV over 24 hours on days 1 and 8, and interleukin-2
subcutaneously on days 1-5 and days 8-12. Treatment continues every 28 days in the absence
of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of interleukin-2 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.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study in less than 2
years.
;
Primary Purpose: Treatment
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