Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence

Phase 2TerminatedNCT01147536

Agenus Inc.12 enrolled

Overview

The primary objective of the study is to determine whether participants exhibit a measurable immune response after multiple administrations of HSPPC-96 (heat shock protein-peptide complex 96), as assessed by enzyme linked immunosorbent spot (ELISPOT) assay.

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 participants 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 participants were to be randomized to the treatment extension arm or the placebo extension arm. There were no participants 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Cell Carcinoma

Interventions

HSPPC-96BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmation of histological diagnosis of renal cell carcinoma (RCC) with evidence of \>= 25% clear cell carcinoma * American joint committee on cancer tumor/node/metastasis tumor stage at intermediate risk for recurrence * At least 8 doses of vaccine available from participant's tumor * Life expectancy of at least 3 months * Eastern cooperative oncology group performance status of 0 or 1 * Cardiovascular disease status of new york heart association class less than 2 * Adequate hematopoietic, renal and hepatic function * Negative serology tests for human immunodeficiency virus (HIV), human T-cell lymphotrophic virus (HTLV-1), hepatitis B surface antigen (HBsAg), anti- hepatitis C virus antibodies (anti-HCV-Ab) * Females must have negative pregnancy test Exclusion Criteria: * Evidence of metastatic or residual RCC * Documented radiological enlarged lymph nodes * Females who are pregnant or breastfeeding * Use of any other investigational product from 4 weeks post-surgery * Splenectomy performed during nephrectomy

Locations (3)

Community Care Physicians

Albany, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Pavillion de Recherche de Hotel Dieu

Québec, Canada

Outcomes

Primary Outcomes

Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay

The ELISPOT assay was not developed for this study and no immunogenicity data are available.

Time frame: 6-7 weeks post surgery up to Week 14

Data from ClinicalTrials.gov

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