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

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

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.

Study Overview

• Status: Terminated
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Biological: HSPPC-96

Detailed Description

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
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1R 2J6
    • Pavillion de Recherche de Hotel Dieu
• United States
  • New York
    • Albany, New York, United States, 12208
      • Community Care Physicians
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HSPPC-96 Vaccine; Participants will receive up to 8 administrations of HSPPC-96 25 µg intradermally over 3 months (4 weekly doses, followed by 4 bi-weekly doses [at Weeks 14, 15, 16, 17 19, 21, 23, and 25 in Part 1a and at Weeks 1-4, 6, 8, 10, 12 in Part 1b). Participants will remain untreated with HSPPC-96 for the initial 3-month period in Part 1a for immune monitoring blood draw.	Biological: HSPPC-96; Other Names: HSPPC-96 (Heat Shock Protein-Peptide Complex); Prophage; Autologous Tumor-Derived HSPPC-96

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6-7 weeks post surgery up to Week 14

Collaborators and Investigators

• Sponsor: Agenus Inc.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: January 29, 2010
• First Submitted That Met QC Criteria: June 17, 2010
• First Posted (Estimate): June 22, 2010

Study Record Updates

• Last Update Posted (Actual): June 3, 2021
• Last Update Submitted That Met QC Criteria: May 10, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Disease Attributes; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Recurrence
• Other Study ID Numbers: C-100-38