Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer

September 6, 2012 updated by: Agenus Inc.

A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma

Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Objective:

  • The primary objective of this study is to determine whether subjects randomized to receive adjuvant HSPPC-96 after surgical resection of locally advanced renal cell carcinoma at high risk of recurrence, have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

Secondary Objective:

  • Determine whether subjects randomized to receive HSPPC-96 have improved survival as compared to subjects with no adjuvant treatment.
  • Further characterize the safety profile of HSPPC-96.

Study Type

Interventional

Enrollment

650

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
  • Belgium
      • Kortrijk, Belgium
      • Liege, Belgium
  • Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • Lille, France
      • Strasbourg, France
      • Toulouse Cedex, France
      • Villejuif Cedex, France
  • Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Tel-Hashomer, Israel
    • Zerifin
      • Beer-Yaacob, Zerifin, Israel
  • Norway
      • Oslo, Norway
      • Stavanger, Norway
  • Poland
      • Bialystok, Poland
      • Gdansk, Poland
      • Kielce, Poland
      • Krakow, Poland
      • Lublin, Poland
      • Szczecin, Poland
      • Warsaw, Poland
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Valencia, Spain
  • Sweden
      • Gothenburg, Sweden
      • Lund, Sweden
      • Umea, Sweden
      • Uppsala, Sweden
  • United Kingdom
      • Bristol, United Kingdom
      • London, United Kingdom
  • United States
    • Alaska
      • Anchorage, Alaska, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Los Angeles, California, United States
      • San Francisco, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Farmington, Connecticut, United States
    • Florida
      • Boca Raton, Florida, United States
      • Miami, Florida, United States
      • Tampa, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Maywood, Illinois, United States
    • Iowa
      • Iowa City, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Louisiana
      • Gretna, Louisiana, United States, 70056
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Massachusetts
      • Boston, Massachusetts, United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • St. Louis, Missouri, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Manhasset, New York, United States
      • New York City, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinatti, Ohio, United States
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Tennessee
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Ft. Worth, Texas, United States
      • Houston, Texas, United States
    • Vermont
      • South Burlington, Vermont, United States
    • Virginia
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Pre-Surgery Inclusion Criteria:

  • Primary-intact resectable renal cell cancer, without known distant metastasis and be scheduled to have surgery with curative intent;
  • Tumor size greater than or equal to 5 cm OR macroscopic nodes OR renal vein thrombus OR vena cava thrombus by radiologic evaluation
  • Performance status (Zubrod / ECOG-WHO scale)less than or equal to 1 and life expectancy of greater than three months, within 2 weeks of surgery.
  • Women of child-bearing potential must have a negative urine or serum pregnancy test within 2 weeks of surgery.
  • Signed written informed consent.

Pre-Surgery Exclusion Criteria:

  • Prior chemo-, hormonal, immuno- or radiotherapy for renal cell cancer;
  • History of primary or secondary immunodeficiency, or patients using immunosuppressive drugs, e.g. systemic corticosteroids, cyclosporin A;
  • Current malignancies at other sites or previous other cancer within the last 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin;
  • Embolization of the renal artery prior to nephrectomy;
  • Known distant metastases;
  • Active, uncontrolled infection or other serious medical illnesses.

Eligibility Assessment:

(between 2 weeks pre- and 4 weeks post-surgery)

Prior to randomization and entry into the tumor evaluation phase, all subjects must undergo testing to confirm that they are free of distant metastatic disease, and that they meet all other criteria.

Eligibility Criteria which must be assessed and confirmed prior to randomization:

  • No evidence of metastatic or residual renal carcinoma as documented by all of the following: abdominal/pelvis CT scan; chest CT scan; and brain CT or MRI scan.
  • Provide Antigenics with greater than or equal to 7 grams of viable tumor tissue
  • Adequate bone marrow function.
  • Adequate renal and hepatic function.
  • Adequate cardiac function.
  • Signed written informed consent.
  • Patients must be willing to be followed during the course of tumor evaluation and follow-up phases.
  • Male or female patients of child producing potential must agree to use adequate contraception during the treatment/observation phase of the study.
  • Patients must not use any other investigational drug for four weeks prior to the start of the tumor evaluation phase and throughout the tumor evaluation phase of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agenus Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

April 12, 2002

First Submitted That Met QC Criteria

April 12, 2002

First Posted (Estimate)

April 15, 2002

Study Record Updates

Last Update Posted (Estimate)

September 7, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-100-12 Part I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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