Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery.
Drug: bryostatin 1
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)|
|Study Start Date:||September 2000|
|Study Completion Date:||January 2004|
|Primary Completion Date:||October 2003 (Final data collection date for primary outcome measure)|
- Determine the dose of bryostatin 1 that, when administered in conjunction with low-dose interleukin-2, maximizes in vitro interleukin-2- stimulated peripheral blood stem cell proliferation in patients with melanoma or renal cell carcinoma.
- Assess other intermediate markers of immune response in patients treated with this regimen.
- Determine tumor responses, response durations, progression-free intervals, and survival of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three bryostatin 1 dose levels.
Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006022
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|United States, Virginia|
|Massey Cancer Center|
|Richmond, Virginia, United States, 23219|
|Study Chair:||John D. Roberts, MD||Massey Cancer Center|