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

Phase 1

Completed

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.

Recruitment & 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

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Single Arm	AGS-003	Single Arm study

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Locations (10): Univ. of Colorado Health Science Center - Division of Medical Oncology
🇺🇸
Aurora, Colorado, United States
Nevada Cancer Institute
🇺🇸
Las Vegas, Nevada, United States
The Indiana University Cancer Center/IUPUI
🇺🇸
Indianapolis, Indiana, United States
UCLA Kidney Cancer Program
🇺🇸
Los Angeles, California, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
Jewish General Hospital
🇨🇦
Montreal, Quebec, Canada
Carolinas Medical Center/Blumenthal Cancer Center
🇺🇸
Charlotte, North Carolina, United States
Princess Margaret Hospital
🇨🇦
Toronto, Ontario, Canada
Earle A. Chiles Research Institute
🇺🇸
Portland, Oregon, United States