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

NCT ID: NCT01147536

Last Updated: 2021-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2012-06-30

Brief Summary

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.

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HSPPC-96

Intervention Type: BIOLOGICAL

Interventions

HSPPC-96

Intervention Type: BIOLOGICAL

Other Intervention Names

HSPPC-96 (Heat Shock Protein-Peptide Complex); Prophage; Autologous Tumor-Derived HSPPC-96

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agenus Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis Lacombe, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec

Christopher G Wood, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

The University of Texas MD Anderson Cancer Center

Ronald P Kaufman, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Community Care Physicians, PC; The Urological Institute of Northeastern New York

Locations

Community Care Physicians

Albany, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Pavillion de Recherche de Hotel Dieu

Québec, , Canada

Countries

United States; Canada

Other Identifiers

C-100-38

Identifier Type: -

Identifier Source: org_study_id

NCT01073254

Identifier Type: -

Identifier Source: nct_alias