Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
The hypothesis of this study is beneficial T cell reactivity in oral squamous cell carcinoma
(OSCC) tumors can be synergistically stimulated by blocking suppressor endothelial cells and
their induction of other inhibitory cell populations while also maturing immune inhibitory
CD34+ cells into antigen-presenting dendritic cells.
To test this hypothesis, newly diagnosed OSCC patients will be administered the COX 2
inhibitor celecoxib and/or 1,25(OH)2D3 for the 3 week duration between cancer diagnosis and
surgical treatment. The following aims will test the immunological and clinical
effectiveness of the combination treatment:
- 1. To block the suppressive activity of endothelial cells and increase the levels of
dendritic that are stimulatory to T cell reactivity, thereby synergistically increasing
intratumoral T cell reactivity. These functional immune analyses will use OSCC tissues
removed from untreated patients or patients treated with celecoxib and/or 1,25(OH)2D3.
- 2. To reduce development of OSCC recurrences by synergistically stimulating
intratumoral T cell reactivity with celecoxib to block suppressor endothelial cell
activity and 1,25(OH)2D3 to mature CD34+ suppressor cells into T cell stimulatory
dendritic cells.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Immunological - increased dendritic cell levels, increased T-cell activity
3 years
No
M. Rita I Young, PhD
Principal Investigator
Ralph H Johnson VA Medical Center, Charleston
United States: Federal Government
CLIN-003-09S
NCT00953849
November 2009
September 2014
Name | Location |
---|---|
Ralph H Johnson VA Medical Center, Charleston | Charleston, South Carolina 29401-5799 |