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Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer
This study has been completed.
First Received: April 12, 2002   Last Updated: July 11, 2007   History of Changes
Sponsor: Antigenics
Information provided by: Antigenics
ClinicalTrials.gov Identifier: NCT00033904
  Purpose

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.


Condition Intervention Phase
Renal Cell Carcinoma
Drug: autologous human tumor-derived HSPPC-96
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Antigenics:

Estimated Enrollment: 650
Study Start Date: June 2000
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033904

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

Additional Information:
No publications provided by Antigenics

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: C-100-12 Part I
Study First Received: April 12, 2002
Last Updated: July 11, 2007
ClinicalTrials.gov Identifier: NCT00033904     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Antigenics:
Kidney Cancer, renal, immunotherapy, tumor,

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Kidney Diseases
Adenocarcinoma
Urologic Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on November 25, 2009