Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer
NCT ID: NCT00033904
Last Updated: 2012-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
650 participants
INTERVENTIONAL
2000-06-30
2007-04-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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autologous human tumor-derived HSPPC-96
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Agenus Inc.
INDUSTRY
Responsible Party
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Locations
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Anchorage, Alaska, United States
Tucson, Arizona, United States
Los Angeles, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Boca Raton, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Gretna, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Manhasset, New York, United States
New York, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Houston, Texas, United States
South Burlington, Vermont, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
Vienna, , Austria
Kortrijk, , Belgium
Liège, , Belgium
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Lille, , France
Strasbourg, , France
Toulouse, , France
Villejuif, , France
Beer-Yaacob, Zerifin, Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Tel Litwinsky, , Israel
Oslo, , Norway
Stavanger, , Norway
Bialystok, , Poland
Gdansk, , Poland
Kielce, , Poland
Krakow, , Poland
Lublin, , Poland
Szczecin, , Poland
Warsaw, , Poland
Barcelona, , Spain
Madrid, , Spain
Valencia, , Spain
Gothenburg, , Sweden
Lund, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Bristol, , United Kingdom
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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C-100-12 Part I
Identifier Type: -
Identifier Source: org_study_id