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Tracking Information | |||||
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First Received Date † | June 26, 2007 | ||||
Last Updated Date | January 7, 2009 | ||||
Start Date † | June 2007 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00492947 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Characterize the immune response to the vaccine [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Dendritic Cell Vaccine for Head and Neck Cancer | ||||
Official Title † | 0608 GCC:Phase I Study of Intra-Tumoral Injection of Dendritic Cells for the Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck | ||||
Brief Summary | This research study is testing a new treatment of cancer of the head and neck. Purpose This research study is being done to:
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Detailed Description | White blood cells are part of the body's defense system. Sometimes when you have cancer, your body does not know that the cancer cells are making you sick. We hope to teach your white blood cells to find and destroy your cancer cells with a vaccine. The vaccine will be made from a special kind of blood cell called a dendritic cell. This is the cell that will carry the information about your cancer to your white blood cells in your body. |
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Study Phase | Phase I | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Squamous Cell Carcinoma of Head and Neck | ||||
Intervention † | Biological: dendritic cell vaccine | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 10 | ||||
Estimated Completion Date | June 2012 | ||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00492947 | ||||
Responsible Party | Jeffrey Wolf, MD, University of Maryland | ||||
Secondary IDs †† | |||||
Study Sponsor † | University of Maryland | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | University of Maryland | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |