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Study Testing the Biologic Activity and Safety of a Vaccine in Patients With Newly Diagnosed Stage IV Kidney Cancer
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase II, Phase I
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Treatment
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Active
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18 and over
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Pharmaceutical / Industry
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AGS-003-004
Bukowski-8077, Logan-0506-05, Drabkin-05-0167, White-04-05-01A, Figlin-05-03-099-01, NCT00272649
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Trial Description
Summary The purpose of this trial is to examine the safety, feasibility, immunological response, and clinical antitumor activity of multiple administrations of dendritic cell vaccine to patients with newly diagnosed with metastatic kidney cancer Further Study Information In this study, a new vaccine 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-vaccine product in RCC subjects. Eligibility Criteria Inclusion Criteria: - Have a new diagnosis of metastatic renal cell carcinoma;
- Must be at least 18 years or older;
- Have a scheduled unilateral nephrectomy or excisional biopsy/metastasectomy
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors Argos Therapeutics, Incorporated | Lothar Finke, MD | | Study Director |
| Argos Clinical Line | | Ph: 919-620-3637 |
Trial Sites
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| U.S.A. |
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| California |
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Los Angeles |
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| | | | | | | | Jonsson Comprehensive Cancer Center at UCLA |
| | | Nazy Zomorodian |
Ph: 310-794-7704 |
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Email:
nzomorodian@mednet.ucla.edu |
| | | Allan Pantuck | Principal Investigator |
| | | Fairooz F. Kabbinavar | Sub-Investigator |
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| Colorado |
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Aurora |
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| | | | University of Colorado Cancer Center at UC Health Sciences Center |
| | | Melissa Gonzales |
Ph: 720-848-0050 |
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Email:
Melissa.Gonzales@uchsc.edu |
| | | Kathryn Breaker |
Ph: 720-848-0651 |
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Email:
Kathryn.Breaker@uchsc.edu |
| | | Harry Drabkin, MD | Principal Investigator |
| | | Kathryn Breaker |
Ph: 720-848-0651 |
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Email:
Kathryn.Breaker@UCHSC.edu |
| | | Michael Glode, MD | Principal Investigator |
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| Indiana |
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Indianapolis |
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| | | | Indiana University Melvin and Bren Simon Cancer Center |
| | | Sheila Dropcho |
Ph: 317-278-4191 |
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Email:
sdropcho@iupui.edu |
| | | Kristin Crowdor |
Ph: 317-274-0792 |
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Email:
kcrowder@iupui.edu |
| | | Theodore F. Logan | Principal Investigator |
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| Nevada |
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Las Vegas |
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| | | | Nevada Cancer Institute |
| | | Leslie Blackwell |
Ph: 702-822-5103 |
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Email:
lblackwell@nvcancer.org |
| | | Nicholas J. Vogelzang | Principal Investigator |
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| North Carolina |
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Charlotte |
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| | | | Blumenthal Cancer Center at Carolinas Medical Center |
| | | Jane Daniels |
Ph: 704-355-5800 |
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Email:
Jane.Daniels@carolinashealthcare.org |
| | | Leigh Young |
Ph: 704-446-5152 |
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Email:
leigh.young@carolinashealthcare.org |
| | | Richard L. White | Principal Investigator |
| | | Asim Amin | Sub-Investigator |
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| Oregon |
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Portland |
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| | | | Providence Cancer Center at Providence Portland Medical Center |
| | | Brenda Fisher |
Ph: 503-215-2613 |
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Email:
brenda.fisher@providence.org |
| | | Brendan Curti, MD | Principal Investigator |
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| Canada |
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| Ontario |
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Toronto |
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| | | | | Princess Margaret Hospital |
| | | Joan Basiuk, R.N. |
Ph: 416-946-4501 Ext.2282 |
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Email:
joan.basiuk@uhn.on.ca |
| | | Jennifer Knox | Principal Investigator |
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| Quebec |
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Montreal |
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| | | | Jewish General Hospital - Montreal |
| | | Caroline Rousseau, BSc. |
Ph: 514-340-8222 Ext.4599 |
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Email:
crousseau@ldi.jgh.mcgill.ca |
| | | Anila Bangash |
Ph: 514-340-8222 Ext.3628 |
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Email:
abangash@ldi.jgh.mcgill.ca |
| | | Victor Cohen, MD | Principal Investigator |
| | | Gerald Batist, MD | Sub-Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00272649
Information obtained from ClinicalTrials.gov on July 16, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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