A Randomized Phase II Study Of Interluekin-2 In Combination With Three Different Doses Of Bryostatin In Patients With Renal Cell Carcinoma
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with advanced renal cell carcinoma
treated with interleukin-2 (IL-2) and bryostatin 1.
II. Compare the toxicity of 3 different doses of bryostatin 1 given in combination with a
fixed dose of IL-2 in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three
dose levels of bryostatin 1.
ARM I: Patients receive interleukin-2 (IL-2) subcutaneously on days 1-4, 8-11, and 15-18.
For the second and subsequent courses of IL-2, patients also receive lowest dose bryostatin
1 IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for at least 3
courses in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive IL-2 as in arm I and middle dose bryostatin 1 IV over 1 hour on
days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of
disease progression or unacceptable toxicity.
ARM III: Patients receive IL-2 as in arm I and highest dose bryostatin 1 IV over 1 hour on
days 1, 8, and 15. Treatment repeats every 28 days for at least 3 courses in the absence of
disease progression or unacceptable toxicity.
Patients with stable or responding disease may receive 3 additional courses of therapy. An
additional cohort of patients receives treatment as above at a higher dose to evaluate
toxicity.
Patients are followed for 1 year.
PROJECTED ACCRUAL: A total of 24-65 patients (8-16 per bryostatin 1 dose level) will be
accrued for this study within 14-27 months.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response (CR and PR)
Will be comparing using Fisher's exact test.
Up to 1 year
No
Walter Stadler
Principal Investigator
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
NCI-2012-02460
NCT00032188
January 2002
Name | Location |
---|---|
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |