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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00272649
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : March 14, 2013
Sponsor:
Information provided by (Responsible Party):
Argos Therapeutics

Study Description
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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

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Biological: AGS-003 Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm
Single Arm study
 Biological: AGS-003
Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)
Other Name: Dendritic Cell Immunotherapeutic


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272649


Locations
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United States, California
UCLA Kidney Cancer Program
Los Angeles, California, United States, 90095-7207
United States, Colorado
Univ. of Colorado Health Science Center - Division of Medical Oncology
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
The Indiana University Cancer Center/IUPUI
Indianapolis, Indiana, United States, 46202
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, North Carolina
Carolinas Medical Center/Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28204
United States, Oregon
Earle A. Chiles Research Institute
Portland, Oregon, United States, 97213-2933
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, MG5 2M9
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Argos Therapeutics
Investigators
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Study Chair: Terry Chew, MD Argos Therapeutics
More Information
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Additional Information:

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Responsible Party: Argos Therapeutics
ClinicalTrials.gov Identifier: NCT00272649    
Obsolete Identifiers: NCT00309829
Other Study ID Numbers: AGS-003-004
Bukowski-8077
Logan-0506-05
Drabkin-05-0167
White-04-05-01A
Figlin-05-03-099-01
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: March 14, 2013
Last Verified: March 2013
Keywords provided by Argos Therapeutics:
Kidney cancer
Renal cancer
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases