Status:
COMPLETED
RNA-Loaded Dendritic Cell Cancer Vaccine
Lead Sponsor:
Argos Therapeutics
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of administering a dendritic cell vaccine to patients with metastatic renal cel...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Have a new diagnosis of metastatic renal cell carcinoma;
- Must be at least 18 years or older;
- Have a scheduled unilateral nephrectomy;
- ECOG of 0 or 1;
- Free of brain metastases by CT or MRI;
- Normal renal function in contralateral kidney;
- Male or non-pregnant/non-lactating female on appropriate birth control methods while on study;
- Clinically acceptable screening results.
- No immunosuppressive therapy not limited to corticosteroids (including topical steroids or steroid containing inhalers), azathioprine cyclosporine two months prior to study entry;
- No active autoimmune disease
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00087984
Start Date
January 1 2004
End Date
September 1 2008
Last Update
February 18 2013
Active Locations (5)
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1
University of California - Irvine
Orange, California, United States, 92868
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
3
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
4
Princess Margaret Hospital
Toronto, Ontario, Canada