Phase I Dose-Escalation Study of the Pharmacokinetic, Safety, Tolerability, and Biologic Activity of huKS-IL-2 Administered Daily as a 1-Hour Intravenous Infusion for Five Consecutive Days for Treatment of Refractory Epithelial Cancer
OBJECTIVES: I. Determine the maximum tolerated dose of KSA-interleukin-2 in patients with
refractory epithelial carcinoma. II. Characterize the pharmacokinetics of this drug in these
patients. III. Assess the overall toxicity and safety of this drug in these patients. IV.
Determine the rate of objective response in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive KSA-interleukin-2
(KSA-IL-2) IV over 1 hour on days 1-5. Treatment repeats every 21 days for a maximum of 6
courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of KSA-IL-2 until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which more than 33% of the
patients experience a dose-limiting toxicity. Patients are followed at 30 days.
PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study within 6-12
Primary Purpose: Treatment
Robert J. Motzer, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Lombardi Cancer Center||Washington, District of Columbia 20007|