Status:
TERMINATED
Clinical Trial Studying a Personalized Cancer Vaccine in Patients With Non-metastatic Kidney Cancer
Lead Sponsor:
Agenus Inc.
Conditions:
Kidney Cancer
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an international, open label, randomized phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with a...
Detailed Description
This is an international, open label, randomized Phase 3 trial in which patients with surgically removable kidney cancer will be randomly selected post-operatively to receive adjuvant treatment with H...
Eligibility Criteria
Inclusion
- This does not represent the full set of inclusion/exclusion criteria
- Patients must have primary-intact resectable renal cell cancer, without distant metastasis and be scheduled to have surgery with curative intent
- Tumor size \> 5 cm OR macroscopic nodes OR vena cava thrombus by radiologic evaluation
- At least 18 years old
- Signed informed consent
Exclusion
- Prior surgery, chemo-, hormonal-, immuno-, or radiotherapy for kidney cancer
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00126178
Start Date
May 1 2005
End Date
March 1 2006
Last Update
September 7 2012
Active Locations (7)
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1
San Francisco, California, United States
2
Stanford, California, United States
3
Hackensack, New Jersey, United States
4
San Antonio, Texas, United States