Clinical trial NCT00272649: Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Renal Cell Carcinoma
Keywords: Kidney cancer
Renal cancer
Lead sponsor: Argos Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.
timeFrame: 24 weeks
Secondary outcomes:
measure: Assess safety of multiple administrations of the Immunotherapeutic in subjects with newly diagnosed, metastatic Renal Cell Cancer Assess Overall Survival and Time to progression
timeFrame: 24 weeks plus follow-up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Kidney Cancer Program
state: California
city: Aurora
country: United States
facility: Univ. of Colorado Health Science Center - Division of Medical Oncology
state: Colorado
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: The Indiana University Cancer Center/IUPUI
state: Indiana
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center/Blumenthal Cancer Center
state: North Carolina
city: Portland
country: United States
facility: Earle A. Chiles Research Institute
state: Oregon
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Argos Therapeutics
name: Terry Chew, MD
role: STUDY_CHAIR
References: