Clinical Trial Studying a Personalized Cancer Vaccine in Patients With Non-metastatic Kidney Cancer
NCT ID: NCT00126178
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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TERMINATED
PHASE3
600 participants
INTERVENTIONAL
2005-05-31
2006-03-31
Brief Summary
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Detailed Description
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The primary objective of the study is to determine whether patients who receive adjuvant autologous HSPPC-96 (treatment group) after surgical resection of locally advanced renal cell carcinoma have improved recurrence-free survival as compared to patients who are not receiving adjuvant treatment (observation group). Eligible patients will have a 50% chance of receiving adjuvant treatment with HSPPC-96. Patients in the treatment arm of the trial will receive the vaccine once a week for 4 weeks, and then every other week until vaccine depletion or disease recurrence. Both groups of patients will be followed regularly for assessment of their disease status.
HSPPC-96 is an investigational, immunotherapeutic agent made from an individual patient's own tumor, which is collected at the time of surgery. A portion of the tumor tissue is sent to Antigenics' manufacturing facility where it will undergo processing to create a vaccine.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Interventions
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HSPPC-96
Eligibility Criteria
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Inclusion Criteria
* Tumor size \> 5 cm OR macroscopic nodes OR vena cava thrombus by radiologic evaluation
* At least 18 years old
* Signed informed consent
Exclusion Criteria
* History of other cancers within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin
* Current malignancies of any type in other sites
* No active uncontrolled infection, other serious medical illnesses, or splenectomy
* History of primary or secondary immunodeficiencies
18 Years
ALL
No
Sponsors
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Agenus Inc.
INDUSTRY
Responsible Party
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Locations
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San Francisco, California, United States
Stanford, California, United States
Hackensack, New Jersey, United States
San Antonio, Texas, United States
South Burlington, Vermont, United States
Victoria, British Columbia, Canada
Toronto, Ontario, Canada
Countries
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Other Identifiers
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C-100-12 Part 2
Identifier Type: -
Identifier Source: org_study_id