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

Last updated: September 6, 2012
Sponsor: Agenus Inc.
Overall Status: Completed

Phase

3

Condition

Kidney Cancer

Carcinoma

Cancer/tumors

Treatment

N/A

Clinical Study ID

NCT00033904
C-100-12 Part I
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Pre-Surgery Inclusion Criteria:

  • Primary-intact resectable renal cell cancer, without known distant metastasis and bescheduled to have surgery with curative intent;

  • Tumor size greater than or equal to 5 cm OR macroscopic nodes OR renal vein thrombusOR vena cava thrombus by radiologic evaluation

  • Performance status (Zubrod / ECOG-WHO scale)less than or equal to 1 and lifeexpectancy of greater than three months, within 2 weeks of surgery.

  • Women of child-bearing potential must have a negative urine or serum pregnancy testwithin 2 weeks of surgery.

  • Signed written informed consent.

Exclusion

Pre-Surgery Exclusion Criteria:

  • Prior chemo-, hormonal, immuno- or radiotherapy for renal cell cancer;

  • History of primary or secondary immunodeficiency, or patients using immunosuppressivedrugs, 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 cervixuteri 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 undergotesting to confirm that they are free of distant metastatic disease, and that they meet allother 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 thefollowing: 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 andfollow-up phases.

  • Male or female patients of child producing potential must agree to use adequatecontraception during the treatment/observation phase of the study.

  • Patients must not use any other investigational drug for four weeks prior to the startof the tumor evaluation phase and throughout the tumor evaluation phase of the study.

Study Design

Total Participants: 650
Study Start date:
June 01, 2000
Estimated Completion Date:
April 30, 2007

Study 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.

Connect with a study center

  • Vienna,
    Austria

    Site Not Available

  • Kortrijk,
    Belgium

    Site Not Available

  • Liege,
    Belgium

    Site Not Available

  • Calgary, Alberta
    Canada

    Site Not Available

  • Vancouver, British Columbia
    Canada

    Site Not Available

  • Victoria, British Columbia
    Canada

    Site Not Available

  • London, Ontario
    Canada

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Montreal, Quebec
    Canada

    Site Not Available

  • Quebec,
    Canada

    Site Not Available

  • Lille,
    France

    Site Not Available

  • Strasbourg,
    France

    Site Not Available

  • Toulouse Cedex,
    France

    Site Not Available

  • Villejuif Cedex,
    France

    Site Not Available

  • Beer-Yaacob, Zerifin
    Israel

    Site Not Available

  • Haifa,
    Israel

    Site Not Available

  • Holon,
    Israel

    Site Not Available

  • Jerusalem,
    Israel

    Site Not Available

  • Tel-Hashomer,
    Israel

    Site Not Available

  • Oslo,
    Norway

    Site Not Available

  • Stavanger,
    Norway

    Site Not Available

  • Bialystok,
    Poland

    Site Not Available

  • Gdansk,
    Poland

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  • Kielce,
    Poland

    Site Not Available

  • Krakow,
    Poland

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  • Lublin,
    Poland

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  • Szczecin,
    Poland

    Site Not Available

  • Warsaw,
    Poland

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  • Barcelona,
    Spain

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  • Madrid,
    Spain

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  • Valencia,
    Spain

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  • Gothenburg,
    Sweden

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  • Lund,
    Sweden

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  • Umea,
    Sweden

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  • Uppsala,
    Sweden

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  • Bristol,
    United Kingdom

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  • London,
    United Kingdom

    Site Not Available

  • Anchorage, Alaska
    United States

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  • Tucson, Arizona
    United States

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  • Los Angeles, California
    United States

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  • San Francisco, California
    United States

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  • Denver, Colorado
    United States

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  • Farmington, Connecticut
    United States

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  • Boca Raton, Florida
    United States

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  • Miami, Florida
    United States

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  • Tampa, Florida
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Chicago, Illinois
    United States

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  • Maywood, Illinois
    United States

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  • Iowa City, Iowa
    United States

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  • Kansas City, Kansas
    United States

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  • Gretna, Louisiana 70056
    United States

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  • Baltimore, Maryland 21287
    United States

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  • Boston, Massachusetts
    United States

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  • Rochester, Minnesota 55905
    United States

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  • St. Louis, Missouri
    United States

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  • Albuquerque, New Mexico
    United States

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  • Manhasset, New York
    United States

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  • New York City, New York
    United States

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  • Charlotte, North Carolina
    United States

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  • Winston-Salem, North Carolina
    United States

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  • Cincinatti, Ohio
    United States

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  • Cleveland, Ohio
    United States

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  • Columbus, Ohio
    United States

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  • Eugene, Oregon
    United States

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  • Portland, Oregon
    United States

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  • Philadelphia, Pennsylvania
    United States

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  • Knoxville, Tennessee
    United States

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  • Nashville, Tennessee
    United States

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  • Ft. Worth, Texas
    United States

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  • Houston, Texas
    United States

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  • South Burlington, Vermont
    United States

    Site Not Available

  • Richmond, Virginia
    United States

    Site Not Available

  • Seattle, Washington
    United States

    Site Not Available

  • Milwaukee, Wisconsin
    United States

    Site Not Available

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