Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Vitamin D - Celecoxib Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Department of Veterans Affairs
Information provided by (Responsible Party):
Department of Veterans Affairs Identifier:
First received: August 4, 2009
Last updated: February 19, 2015
Last verified: February 2015

The poor survival of veterans with oral cancer underscores the significance of identifying new treatment approaches. The proposed studies will test a new 2 pronged immunotherapeutic approach for oral cancer patients which lessen the immune inhibitory environment while maturing cells that can stimulate T cell reactivity against oral cancer cells.

Condition Intervention Phase
Mouth Neoplasms
Drug: celecoxib
Drug: 1,25-dihydroxyvitamin D3 + celecoxib
Drug: 1,25-dihydroxyvitamin D3
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity

Resource links provided by NLM:

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Immunological - increased dendritic cell levels, increased T-cell activity [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: November 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
oral cancer patients receiving new immunotherapy prior to surgery
Drug: 1,25-dihydroxyvitamin D3
3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)
Other Name: calcitriol
Experimental: Arm 2
oral cancer patients receiving new immunotherapy prior to surgery
Drug: celecoxib
celecoxib (400 mg twice daily)
Experimental: Arm 3
oral cancer patients receiving new immunotherapy prior to surgery
Drug: 1,25-dihydroxyvitamin D3 + celecoxib
3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)
No Intervention: Arm 4
oral cancer patients receiving no immunotherapy prior to surgery

Detailed Description:

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.

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00953849

Contact: Judith Skoner, MD (843) 789-7330

United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston Recruiting
Charleston, South Carolina, United States, 29401-5799
Contact: Judith Skoner, MD    843-789-7330   
Principal Investigator: M. Rita I Young, PhD         
Sponsors and Collaborators
Principal Investigator: M. Rita I Young, PhD Ralph H Johnson VA Medical Center, Charleston
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs Identifier: NCT00953849     History of Changes
Other Study ID Numbers: CLIN-003-09S
Study First Received: August 4, 2009
Last Updated: February 19, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Mouth Diseases
Neoplasms by Site
Stomatognathic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Growth Substances
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 26, 2015