Bryostatin 1 and Interleukin-2 in Treating Patients With Refractory Solid Tumors or Lymphoma
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.
|Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific||Biological: aldesleukin Drug: bryostatin 1||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||September 1999|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003993
|United States, Maryland|
|National Institute on Aging - Baltimore|
|Baltimore, Maryland, United States, 21224-6825|
|Study Chair:||Igor Espinoza-Delgado, MD||Gerontology Research Center|