Status:
TERMINATED
Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma
Lead Sponsor:
Agenus Inc.
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individ...
Detailed Description
The goal of this trial is to determine the safety of HSPPC-96 and which route of administration achieves a better response with the vaccine. HSPPC-96 is an immunotherapeutic agent made from an individ...
Eligibility Criteria
Inclusion
- Suspected metastatic renal cell carcinoma (AJCC Stage IV) with intact primary tumor
- No previous therapy for metastatic renal cell carcinoma
- Measurable disease (RECIST criteria)
- Primary tumor greater than or equal to 7cm on CT or MRI
- ECOG performance status 0-1
- At least 18 years old
- Life expectancy \> 3 months
- Adequate cardiac function (NYHA I-II)
- Not pregnant
- Provide written informed consent
- Absence of multiple liver metastases, brain or threatening bone metastases (axial skeleton and/or pathological features)
- Planned complete nephrectomy
Exclusion
- History of primary or secondary immunodeficiency, or patients using systemic corticosteroids or cyclosporin A
- Other cancer (including renal cell carcinoma) within the last five 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
- Active, uncontrolled infection or other serious medical illnesses, preventing study completion, in the opinion of the Principal Investigator
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00082459
Start Date
July 1 2002
End Date
December 1 2005
Last Update
September 7 2012
Active Locations (1)
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1
Houston, Texas, United States