Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney Cancer
This study has been completed.
Sponsor:
Argos Therapeutics
Information provided by (Responsible Party):
Argos Therapeutics
ClinicalTrials.gov Identifier:
NCT00272649
First received: January 6, 2006
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Renal Cell Carcinoma |
Biological: AGS-003 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Argos Therapeutics:
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. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 weeks plus follow-up ] [ Designated as safety issue: Yes ]
| Enrollment: | 22 |
| Study Start Date: | January 2006 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Arm
Single Arm study
|
Biological: AGS-003
Dendritic cell, autologous cellular immunotherapy. (Arcelis platform)
Other Name: Dendritic Cell Immunotherapeutic
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272649
Locations
| 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
| Study Chair: | Terry Chew, MD | Argos Therapeutics |
More Information
Additional Information:
No publications provided
| Responsible Party: | Argos Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00272649 History of Changes |
| 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 |
| Study First Received: | January 6, 2006 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Argos Therapeutics:
|
Kidney cancer Renal cancer |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013