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

Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272649
• Other study ID #: AGS-003-004
• Secondary ID: Bukowski-8077Log
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 6, 2006
• Last updated: March 6, 2013
• Start date: January 2006
• Est. completion date: February 2012

Study information

• Verified date: March 2013
• Source: Argos Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT00309829

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Biological:
• AGS-003
Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Emory University	Atlanta	Georgia
United States	Univ. of Colorado Health Science Center - Division of Medical Oncology	Aurora	Colorado
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Carolinas Medical Center/Blumenthal Cancer Center	Charlotte	North Carolina
United States	The Indiana University Cancer Center/IUPUI	Indianapolis	Indiana
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	UCLA Kidney Cancer Program	Los Angeles	California
United States	Earle A. Chiles Research Institute	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Argos Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.		24 weeks	No
Secondary	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	Yes

External Links

•   Kidney Cancer Association