Back to resultsStudy of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
Primary Purpose
Renal Cell Carcinoma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HSPPC-96
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma
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
Sites / Locations
- Community Care Physicians
- MD Anderson Cancer Center
- Pavillion de Recherche de Hotel Dieu
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HSPPC-96 Vaccine
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01147536
Brief Title
Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's business decision
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Agenus Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HSPPC-96 Vaccine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
HSPPC-96
Other Intervention Name(s)
HSPPC-96 (Heat Shock Protein-Peptide Complex), Prophage, Autologous Tumor-Derived HSPPC-96
Primary Outcome Measure Information:
Title
Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Lacombe, MD, FRCSC
Organizational Affiliation
Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher G Wood, MD, FACS
Organizational Affiliation
The University of Texas MD Anderson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ronald P Kaufman, MD, FACS
Organizational Affiliation
Community Care Physicians, PC; The Urological Institute of Northeastern New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Care Physicians
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pavillion de Recherche de Hotel Dieu
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
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