Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer
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
1 other identifier
interventional
650
11 countries
76
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2000
Longer than P75 for phase_3
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedFirst Submitted
Initial submission to the registry
April 12, 2002
CompletedFirst Posted
Study publicly available on registry
April 15, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedSeptember 7, 2012
September 1, 2012
6.8 years
April 12, 2002
September 6, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Agenus Inc.lead
Study Sites (76)
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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
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Atlanta, Georgia, United States
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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, New York, United States
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Rochester, 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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Cincinnati, 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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Fort Worth, Texas, United States
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Houston, Texas, United States
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South Burlington, Vermont, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Vienna, Austria
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Kortrijk, Belgium
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Liège, Belgium
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Lille, France
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Strasbourg, France
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Toulouse, France
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Villejuif, France
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Beer-Yaacob, Zerifin, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Tel Litwinsky, Israel
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Oslo, Norway
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Stavanger, Norway
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Bialystok, Poland
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Gdansk, Poland
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Kielce, Poland
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Krakow, Poland
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Lublin, Poland
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Szczecin, Poland
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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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Umeå, Sweden
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Uppsala, Sweden
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Bristol, United Kingdom
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London, United Kingdom
Related Publications (1)
Wood C, Srivastava P, Bukowski R, Lacombe L, Gorelov AI, Gorelov S, Mulders P, Zielinski H, Hoos A, Teofilovici F, Isakov L, Flanigan R, Figlin R, Gupta R, Escudier B; C-100-12 RCC Study Group. An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial. Lancet. 2008 Jul 12;372(9633):145-154. doi: 10.1016/S0140-6736(08)60697-2. Epub 2008 Jul 3.
PMID: 18602688DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2002
First Posted
April 15, 2002
Study Start
June 1, 2000
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
September 7, 2012
Record last verified: 2012-09