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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

Thank you

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