Phase IB Open-Label Rising-Dose Study of Biomed 101 in Patients Treated With Interleukin-2 for Malignancy
OBJECTIVES: I. Evaluate the safety and maximum tolerated dose of Biomed 101 in patients with
renal cell cancer currently treated with interleukin-2 (IL-2). II. Evaluate the effect of
different doses of Biomed 101 on the incidence and severity of IL-2 related toxicities and
on the incidence and frequency of IL-2 dose reduction due to IL-2 induced toxicity.
OUTLINE: This is a dose escalation study of Biomed 101. Patients receive oral Biomed 101
three times daily, followed by interleukin-2 IV on days 1-5 and 16-20. Cohorts of 5 patients
receive escalating doses of Biomed 101 until the maximum tolerated dose (MTD) is determined.
The MTD is defined as the dose preceding that at which at least 2 of 5 patients experience
dose limiting toxicities. Patients are followed for 1 month.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Primary Purpose: Treatment
Robert A. Figlin, MD, FACP
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|