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Immune Response Following Treatment of Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence

2014-08-27 03:12:48 | BioPortfolio

Summary

Renal cell carcinoma patients' blood will be monitored over a period of 15 weeks to evaluate their level of immune response to multiple administration of HSPPC-96.

Description

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).

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Renal Cell Carcinoma

Intervention

HSPPC-96

Location

Community Care Physicians
Albany
New York
United States
12208

Status

Recruiting

Source

Antigenics

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:48-0400

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