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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center National Cancer Institute (NCI) |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00458536 |
The main purpose of this study is to test the safety of the dendritic cell/tumor fusion study vaccine in combination with a laboratory-made agent called Granulocyte Macrophage Colony Stimulating Factor (GM-CSF). Another purpose is to determine the type and severity of any side effects associated with this study vaccine. GM-CSF is similar to a substance in the body that stimulates the production of white blood cells. To create the study vaccine, cells will be removed from the participants tumor and fused with dendritic cells which are obtained from the participants blood. Dendritic cells are responsible for immune responses to "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.
Condition | Intervention | Phase |
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Renal Cancer |
Biological: Dendritic Cell Tumor Fusion Vaccine Drug: Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Vaccination of Patients With Renal Cell Cancer With Dendritic Cell Tumor Fusions and GM-CSF |
Estimated Enrollment: | 51 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Avigan, MD | 617-667-9920 | davigan@bidmc.harvard.edu |
Contact: Dilani Dombagoda | 617-667-5984 | ddombago@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Contact: David Avigan, MD 617-667-9920 davigan@bidmc.harvard.edu | |
Contact: Dilani Dombagoda 617-667-5984 ddombago@bidmc.harvard.edu | |
Sub-Investigator: Jacalyn Rosenblatt, MD | |
Sub-Investigator: James D Levine, MD | |
Sub-Investigator: Robin Joyce, MD | |
Sub-Investigator: Lynne Uhl, MD | |
Sub-Investigator: David McDermott, MD | |
Sub-Investigator: Michael Atkins, MD | |
Sub-Investigator: James Mier, MD | |
Sub-Investigator: Donald Kufe, MD | |
Sub-Investigator: Daniel Cho, MD | |
Sub-Investigator: Corrine Lenahan, MD |
Principal Investigator: | David Avigan, MD | Beth Israel Deaconess Medical Center |
Responsible Party: | Beth Israel Deaconess Medical Center ( David Avigan, MD ) |
Study ID Numbers: | 04-117 |
Study First Received: | April 10, 2007 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00458536 |
Health Authority: | United States: Food and Drug Administration |
GM-CSF vaccine debulking nephrectomy dendritic cells |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Urogenital Neoplasms Renal cancer Kidney Diseases |
Kidney cancer Urologic Neoplasms Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |