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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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ClinicalTrials.gov Identifier: NCT01147536
Recruitment Status : Terminated (Sponsor's business decision)
First Posted : June 22, 2010
Results First Posted : June 3, 2021
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Agenus Inc.

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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: HSPPC-96 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012


Arm Intervention/treatment
Experimental: 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.
Biological: HSPPC-96
Other Names:
  • HSPPC-96 (Heat Shock Protein-Peptide Complex)
  • Prophage
  • Autologous Tumor-Derived HSPPC-96




Primary Outcome Measures :
  1. Number of Participants With Positive Immunological Response Using Enzyme Linked Immunosorbent Assay (ELISPOT) Assay [ Time Frame: 6-7 weeks post surgery up to Week 14 ]
    The ELISPOT assay was not developed for this study and no immunogenicity data are available.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147536


Locations
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United States, New York
Community Care Physicians
Albany, New York, United States, 12208
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada
Pavillion de Recherche de Hotel Dieu
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Agenus Inc.
Investigators
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Principal Investigator: Louis Lacombe, MD, FRCSC Service d'Urologie; Centre hospitalier universitaire de Quebec - Hotel-Dieu de Quebec
Principal Investigator: Christopher G Wood, MD, FACS The University of Texas MD Anderson Cancer Center
Principal Investigator: Ronald P Kaufman, MD, FACS Community Care Physicians, PC; The Urological Institute of Northeastern New York
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Responsible Party: Agenus Inc.
ClinicalTrials.gov Identifier: NCT01147536    
Obsolete Identifiers: NCT01073254
Other Study ID Numbers: C-100-38
First Posted: June 22, 2010    Key Record Dates
Results First Posted: June 3, 2021
Last Update Posted: June 3, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases