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

NCT ID: NCT00272649

Last Updated: 2013-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2012-02-29

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

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Single Arm study

Group Type: EXPERIMENTAL

AGS-003

Intervention Type: BIOLOGICAL

Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)

Interventions

AGS-003

Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)

Intervention Type: BIOLOGICAL

Other Intervention Names

Dendritic Cell Immunotherapeutic

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Argos Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Terry Chew, MD

Role: STUDY_CHAIR

Argos Therapeutics

Locations

UCLA Kidney Cancer Program

Los Angeles, California, United States

Univ. of Colorado Health Science Center - Division of Medical Oncology

Aurora, Colorado, United States

Emory University

Atlanta, Georgia, United States

The Indiana University Cancer Center/IUPUI

Indianapolis, Indiana, United States

Nevada Cancer Institute

Las Vegas, Nevada, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Carolinas Medical Center/Blumenthal Cancer Center

Charlotte, North Carolina, United States

Earle A. Chiles Research Institute

Portland, Oregon, United States

Princess Margaret Hospital

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

Related Links

http://www.nkca.org

Kidney Cancer Association

Other Identifiers

Bukowski-8077

Identifier Type: -

Identifier Source: secondary_id

Logan-0506-05

Identifier Type: -

Identifier Source: secondary_id

Drabkin-05-0167

Identifier Type: -

Identifier Source: secondary_id

White-04-05-01A

Identifier Type: -

Identifier Source: secondary_id

Figlin-05-03-099-01

Identifier Type: -

Identifier Source: secondary_id

AGS-003-004

Identifier Type: -

Identifier Source: org_study_id

NCT00309829

Identifier Type: -

Identifier Source: nct_alias