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Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity

Phase 1/Phase 2
18 Years
85 Years
Open (Enrolling)
Mouth Neoplasms

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Trial Information

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.

Inclusion Criteria:

- locoregional OSCC (T stage II-IV) of the oral cavity, oropharynx, larynx, or
hypopharynx without evidence of distant metastases

- greater than or equal to 18 years of age

- the OSCC treatment plan includes surgical resection

- SWOG performance status of 0 or 1

- recovered from any prior surgery

- must be willing to use appropriate contraception if of child-bearing potential

- give signed informed consent prior to the initiation of therapy

Exclusion Criteria:

- prior immunotherapy

- chemotherapy or radiation therapy within three weeks

- concurrent NSAID treatments while undergoing treatment

- women pregnant or lactating

- HIV positive

- have an active infection requiring antibiotic therapy, or concomitant malignancies

- history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or
gastrointestinal malabsorptive conditions

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Immunological - increased dendritic cell levels, increased T-cell activity

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

M. Rita I Young, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ralph H Johnson VA Medical Center, Charleston


United States: Federal Government

Study ID:




Start Date:

November 2009

Completion Date:

September 2014

Related Keywords:

  • Mouth Neoplasms
  • Calcitriol
  • Celecoxib
  • Immunotherapy
  • Neoplasms
  • Mouth Neoplasms



Ralph H Johnson VA Medical Center, Charleston Charleston, South Carolina  29401-5799