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Immune Response Following Treatment of Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01147536
Recruitment Status : Terminated (Sponsor's business decision)
First Posted : June 22, 2010
Last Update Posted : April 10, 2014
Information provided by (Responsible Party):
Agenus Inc.

Tracking Information
First Submitted Date  ICMJE January 29, 2010
First Posted Date  ICMJE June 22, 2010
Last Update Posted Date April 10, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2010)
immunological response in blood sample using ELISPOT assay [ Time Frame: 15 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Immune Response Following Treatment of Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence
Official Title  ICMJE 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
Brief Summary Renal cell carcinoma patients' blood will be monitored over a period of 15 weeks to evaluate their level of immune response to multiple administration of HSPPC-96.
Detailed Description

A multicenter, randomized, single-blind study to assess patients' immune response following treatment with HSPPC-96 (vitespen, Oncophage®)for resectable renal cell carcinoma (RCC), considered to be at intermediate risk for recurrence given the pathologic tumor stage at time of resection.

The purpose of this study is to determine whether patients exhibit a measurable and durable immune response after multiple administrations of HSPPC-96 during a maximum 15-month time period.

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 patients 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 patients were to be randomized to the Treatment Extension Arm or the Placebo Extension Arm. There were no patients 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE Biological: HSPPC-96
HSPPC-96 intradermal injection every week for 4 weeks, followed by an injection every other week for 8 weeks
Other Names:
  • HSPPC-96 (Heat Shock Protein-Peptide Complex)
  • Oncophage
  • Vitespen
  • Autologous Tumor-Derived HSPPC-96
Study Arms  ICMJE Experimental: HSPPC-96 treatment
Intervention: Biological: HSPPC-96
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 20, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2010)
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • confirmation of histological diagnosis of RCC with evidence of >/= 25% clear cell carcinoma
  • AJCC TNM tumor stage at intermediate risk for recurrence
  • at least 8 doses of vaccine available from patient's tumor
  • life expectancy of at least 3 months
  • ECOG PS of 0 or 1
  • Cardiovascular disease status of NYHA class less than 2
  • adequate hematopoietic, renal and hepatic function
  • negative serology tests for HIV, HTLV-1, HBsAg, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01147536
Other Study ID Numbers  ICMJE C-100-38
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Agenus Inc.
Study Sponsor  ICMJE Agenus Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Agenus Inc.
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP