Back to resultsStudy Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer
Primary Purpose
Renal Cell Carcinoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AGS-003
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Kidney cancer, Renal cancer
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
Sites / Locations
- UCLA Kidney Cancer Program
- Univ. of Colorado Health Science Center - Division of Medical Oncology
- Emory University
- The Indiana University Cancer Center/IUPUI
- Nevada Cancer Institute
- Roswell Park Cancer Institute
- Carolinas Medical Center/Blumenthal Cancer Center
- Earle A. Chiles Research Institute
- Princess Margaret Hospital
- Jewish General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Single Arm study
Outcomes
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00272649
Brief Title
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
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Argos Therapeutics
4. Oversight
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Kidney cancer, Renal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Single Arm study
Intervention Type
Biological
Intervention Name(s)
AGS-003
Other Intervention Name(s)
Dendritic Cell Immunotherapeutic
Intervention Description
Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)
Primary Outcome Measure Information:
Title
1. Measure tumor response by RECIST as CR, PR, SD, PD. 2. Measure T-cell responses to vaccination using induction vaccination regimens.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Assess safety of multiple administrations of the Immunotherapeutic in subjects with newly diagnosed, metastatic Renal Cell Cancer Assess Overall Survival and Time to progression
Time Frame
24 weeks plus follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Chew, MD
Organizational Affiliation
Argos Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA Kidney Cancer Program
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-7207
Country
United States
Facility Name
Univ. of Colorado Health Science Center - Division of Medical Oncology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Indiana University Cancer Center/IUPUI
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Carolinas Medical Center/Blumenthal Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Earle A. Chiles Research Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2933
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
MG5 2M9
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.nkca.org
Description
Kidney Cancer Association
Learn more about this trial
Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer
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