Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
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|ClinicalTrials.gov Identifier: NCT00953849|
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : December 21, 2016
Last Update Posted : March 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mouth Neoplasms||Drug: Celecoxib Drug: Calcitriol Drug: Celecoxib plus Calcitriol||Phase 1 Phase 2|
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 cyclooxigenase 2 inhibitor celecoxib and/or Calcitriol 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 Calcitriol.
- 2. To reduce development of OSCC recurrences by synergistically stimulating intratumoral T cell reactivity with celecoxib to block suppressor endothelial cell activity and Calcitriol to mature CD34+ suppressor cells into T cell stimulatory dendritic cells.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity|
|Study Start Date :||November 2009|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
Experimental: Arm 1: Celecoxib
Celecoxib treatment prior to surgery
Celecoxib (400 mg twice daily)
Other Name: Celebrex
Experimental: Arm 2: Calcitriol
Treatment with Calcitriol prior to surgery
3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment)
Other Name: 1,25-dihydroxyvitamin D3
Experimental: Arm 3: Celecoxib plus Calcitriol
Treatment with Celecoxib plus Calcitriol prior to surgery.
Drug: Celecoxib plus Calcitriol
3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)
Other Name: 1,25-dihydroxyvitamin D3
No Intervention: Arm 4: No Treatment
no treatment prior to surgery
- Change in IL-2 Levels [ Time Frame: baseline and 3 weeks ]Change in IL-2 stimulatory cytokine levels within tumor tissue.
- Change in IFN-gamma Levels [ Time Frame: baseline and 3 weeks ]Change in IFN-gamma stimulatory cytokine levels within tumor tissue.
- Change in GM-CSF [ Time Frame: baseline and 3 weeks ]Change in GM-CSF stimulatory cytokine levels within tumor tissue.
- Change in IL-6 Levels. [ Time Frame: baseline and 3 weeks ]Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953849
|United States, South Carolina|
|Ralph H. Johnson VA Medical Center, Charleston, SC|
|Charleston, South Carolina, United States, 29401-5799|
|Principal Investigator:||M. Rita I Young, PhD||Ralph H. Johnson VA Medical Center, Charleston, SC|