Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555)
- 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
- 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
John D. Roberts, MD
Massey Cancer Center
United States: Federal Government
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|
|Massey Cancer Center||Richmond, Virginia 23298-0037|