Kidney Cancer Clinical Trial
Official title:
Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)
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.
OBJECTIVES:
- 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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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