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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00809588 |
The purpose of this study is to see if the proposed therapy will delay or stop the progression of the participants skin cancer. This study is being done because there are currently no treatments which have been shown convincing to treat disease which has progressed. This research study is designed to evaluate the immunologic effects and clinical side effects of giving vaccines to patients that are made from their own skin cancer cells.
Condition | Intervention | Phase |
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Melanoma |
Biological: Autologous, lethally irradiated melanoma cells |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase IB Study of Vaccination With Autologous, Lethally Irradiated Melanoma Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Human Granulocyte-Macrophage Stimulating Factor |
Estimated Enrollment: | 70 |
Study Start Date: | October 2003 |
Estimated Primary Completion Date: | October 2010 (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: F. Stephen Hodi, MD | 617-632-5053 |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: F. Stephen Hodi, MD | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Donald Lawrence, MD |
Principal Investigator: | F. Stephen Hodi, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( F. Stephen Hodi, MD ) |
Study ID Numbers: | 03-218 |
Study First Received: | December 16, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00809588 |
Health Authority: | United States: Food and Drug Administration |
vaccination GM-CSF autologous irradiated |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |