Status:
COMPLETED
Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer
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 multiple administrations of dendritic cell Immunotherapeutic to patients wit...
Detailed Description
In this study, a new Immunotherapeutic production process will be used that shows evidence of potentially much higher biologic activity in pre-clinical studies than the production process used in a pr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Have a new diagnosis of metastatic renal cell carcinoma;
- Measurable disease
- Must be at least 18 years or older;
- Have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy
- 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 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00272649
Start Date
January 1 2006
End Date
February 1 2012
Last Update
March 14 2013
Active Locations (10)
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1
UCLA Kidney Cancer Program
Los Angeles, California, United States, 90095-7207
2
Univ. of Colorado Health Science Center - Division of Medical Oncology
Aurora, Colorado, United States, 80045
3
Emory University
Atlanta, Georgia, United States, 30322
4
The Indiana University Cancer Center/IUPUI
Indianapolis, Indiana, United States, 46202