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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01147536
• Other study ID #: C-100-38
• Status: Terminated
• Phase: Phase 2
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2021
• Source: Agenus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01073254

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Recurrence
• Renal Cell Carcinoma

Intervention

Biological:
• HSPPC-96

Locations

Country	Name	City	State
Canada	Pavillion de Recherche de Hotel Dieu	Quebec
United States	Community Care Physicians	Albany	New York
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Agenus Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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