Status:
TERMINATED
Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
Lead Sponsor:
Agenus Inc.
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 asse...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01147536
Start Date
January 1 2010
End Date
June 1 2012
Last Update
June 3 2021
Active Locations (3)
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1
Community Care Physicians
Albany, New York, United States, 12208
2
MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Pavillion de Recherche de Hotel Dieu
Québec, Canada, G1R 2J6