Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer - Full Text View

Sponsored by:	Argos Therapeutics
Information provided by:	Argos Therapeutics
ClinicalTrials.gov Identifier:	NCT00272649

Purpose

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 with newly diagnosed with metastatic kidney cancer

Condition	Intervention	Phase
Renal Cell Carcinoma	Biological: AGS-003	Phase I Phase II

MedlinePlus related topics: Cancer Kidney Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Argos Therapeutics:

Primary Outcome Measures:

1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess safety of multiple administrations of the Immunotherapeutic in subjects with newly diagnosed, metastatic Renal Cell Cancer Assess Overall Survival and Time to progression [ Time Frame: 24 weeks plus follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	26
Study Start Date:	January 2006
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: Experimental Single Arm study	Biological: AGS-003 Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272649

Locations

United States, California
UCLA Kidney Cancer Program
Los Angeles, California, United States, 90095-7207
United States, Colorado
Univ. of Colorado Health Science Center - Division of Medical Oncology
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
The Indiana University Cancer Center/IUPUI
Indianapolis, Indiana, United States, 46202
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, North Carolina
Carolinas Medical Center/Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28204
United States, Oregon
Earle A. Chiles Research Institute
Portland, Oregon, United States, 97213-2933
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, MG5 2M9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2

Sponsors and Collaborators

Argos Therapeutics

Investigators

Study Director:

Lothar Finke, MD

Argos Therapeutics

More Information

Kidney Cancer Association This link exits the ClinicalTrials.gov site

Responsible Party:	Argos Therapeutics, Inc. ( Lothar Finke/ Chief Medical Officer and VP of Regulatory Affairs )
Study ID Numbers:	AGS-003-004, Bukowski-8077, Logan-0506-05, Drabkin-05-0167, White-04-05-01A, Figlin-05-03-099-01
Study First Received:	January 6, 2006
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00272649
Health Authority:	United States: Food and Drug Administration

Keywords provided by Argos Therapeutics:

Kidney cancer
Renal cancer

Study placed in the following topic categories:

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Renal cancer
Kidney Diseases

Kidney cancer
Adenocarcinoma
Urologic Neoplasms
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009