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Immune Response Following Treatment of 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
Last Update Posted : April 10, 2014
Sponsor:
Information provided by (Responsible Party):
Agenus Inc.

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: HSPPC-96 treatment 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


Outcome Measures
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Primary Outcome Measures :
  1. immunological response in blood sample using ELISPOT assay [ Time Frame: 15 months ]

Eligibility Criteria
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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 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
Contacts and Locations
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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
More Information
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Responsible Party: Agenus Inc.
ClinicalTrials.gov Identifier: NCT01147536     History of Changes
Obsolete Identifiers: NCT01073254
Other Study ID Numbers: C-100-38
First Posted: June 22, 2010    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Recurrence
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
 Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes