A Phase 2, Multicenter, Randomized, Single-Blind Study of Vitespen (HSPPC-96, Oncophage)for Immune Response Assessment Following Treatment of Patients With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
A multicenter, randomized, single-blind study to assess patients' immune response following
treatment with HSPPC-96 (vitespen, Oncophage®)for resectable renal cell carcinoma (RCC),
considered to be at intermediate risk for recurrence given the pathologic tumor stage at
time of resection.
The purpose of this study is to determine whether patients exhibit a measurable and durable
immune response after multiple administrations of HSPPC-96 during a maximum 15-month time
The study consists of two parts: Part 1 with Part 1a (Assessment of Immune Variation)and
Part 1b (Assay Standardization), and Part 2 (Immune Monitoring Study).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
immunological response in blood sample using ELISPOT assay
Louis Lacombe, MD, FRCSC
Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Community Care Physicians||Albany, New York 12208|