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

NCT01147536 | Terminated Phase 2 Results

• 1 other identifier: C-100-38
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 3

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

HSPPC-96 Vaccine

EXPERIMENTAL

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

Interventions

HSPPC-96 BIOLOGICAL

Also known as: HSPPC-96 (Heat Shock Protein-Peptide Complex), Prophage, Autologous Tumor-Derived HSPPC-96

HSPPC-96 Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Agenus Inc.: lead

Study Sites (3)

Community Care Physicians

Albany, New York, 12208, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Pavillion de Recherche de Hotel Dieu

Québec, G1R 2J6, Canada

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

vitespin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Limitations and Caveats

Due to Business reasons, the study was terminated early and the Part 2 portion was not conducted.

Results Point of Contact

• Title: Agenus, Inc. Clinical Trial Information
• Organization: Agenus Inc.

clinicaltrialinfo@Agenusbio.com

781-674-4265

Study Officials

• Louis Lacombe, MD, FRCSC

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

  PRINCIPAL INVESTIGATOR

• Christopher G Wood, MD, FACS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Ronald P Kaufman, MD, FACS

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: June 22, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 3, 2021
• Results First Posted: June 3, 2021

Record last verified: 2021-05

Locations

US (2); CA (1)