A Phase I/II Study Testing the Biologic Activity and Safety of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Stage IV Renal Cell Carcinoma
18 Years
N/A
Both
Renal Cell Carcinoma
Trial Information
A Phase I/II Study Testing the Biologic Activity and Safety of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Stage IV Renal Cell Carcinoma
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 previous study (clinical protocol MB-002-003). While both processes are
based on individual subject autologous tumor RNA and autologous monocyte derived DCs, the
maturation of DCs in this newly modified process involves an altered regimen of culture with
cytokines. In addition, huCD40L mRNA is added to the autologous expanded tumor total mRNA
for electroporation. These changes promise a much improved migration, and activity profile
of the DC-Immunotherapeutic product in RCC subjects.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
Terry Chew, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Argos Therapeutics
Authority:
United States: Food and Drug Administration
Study ID:
AGS-003-004
NCT ID:
NCT00272649
Start Date:
January 2006
Completion Date:
February 2012
Related Keywords:
- Renal Cell Carcinoma
- Kidney cancer
- Renal cancer
- Carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Emory University | Atlanta, Georgia 30322 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| Carolinas Medical Center/Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
| Earle A. Chiles Research Institute | Portland, Oregon 97213 |
| UCLA Kidney Cancer Program | Los Angeles, California 90095-7207 |
| Univ. of Colorado Health Science Center - Division of Medical Oncology | Aurora, Colorado 80045 |
| The Indiana University Cancer Center/IUPUI | Indianapolis, Indiana 46202 |
