Immune Response Following Treatment of Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||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|
- immunological response in blood sample using ELISPOT assay [ Time Frame: 15 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Experimental: HSPPC-96 treatment||
HSPPC-96 intradermal injection every week for 4 weeks, followed by an injection every other week for 8 weeks
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 period.
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).
The study was terminated early with 12 patients enrolled only in Part 1a and Part 1b. Part 2 of the study involved randomization after 8 doses of HSSPC-96. After the 8 doses of HSSPC-96 administered in Part 2, the patients were to be randomized to the Treatment Extension Arm or the Placebo Extension Arm. There were no patients enrolled in Part 2 since the study was terminated early. Therefore, no randomization occurred in the conduct of this study and only a single arm was enrolled.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147536
|United States, New York|
|Community Care Physicians|
|Albany, New York, United States, 12208|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Pavillion de Recherche de Hotel Dieu|
|Quebec, Canada, G1R 2J6|
|Principal Investigator:||Louis Lacombe, MD, FRCSC||Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec|
|Principal Investigator:||Christopher G Wood, MD, FACS||The University of Texas, MD Anderson Cancer Center|
|Principal Investigator:||Ronald P Kaufman, MD, FACS||Community Care Physicians, PC; The Urological Institute of Northeastern New York|