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
- 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
- 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
- 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
Primary Purpose: Treatment
Igor Espinoza-Delgado, MD
Gerontology Research Center
United States: Federal Government
|National Institute on Aging - Baltimore||Baltimore, Maryland 21224-6825|