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

Sponsor

Argos Therapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT00272649

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

2.2

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 with newly diagnosed with metastatic kidney cancer

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma	Biological: AGS-003	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm Single Arm study	Biological: AGS-003 Dendritic cell, autologous cellular immunotherapy. (Arcelis platform) Other Names: Dendritic Cell Immunotherapeutic

Arm

Intervention/Treatment

Experimental: Single Arm

Single Arm study

Biological: AGS-003

Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)

Other Names:

Dendritic Cell Immunotherapeutic

Outcome Measures

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. [24 weeks]

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 [24 weeks plus follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
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
5	Nevada Cancer Institute	Las Vegas	Nevada	United States	89135
6	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
7	Carolinas Medical Center/Blumenthal Cancer Center	Charlotte	North Carolina	United States	28204
8	Earle A. Chiles Research Institute	Portland	Oregon	United States	97213-2933
9	Princess Margaret Hospital	Toronto	Ontario	Canada	MG5 2M9
10	Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2