Vitamin D - Celecoxib Therapy
This study is currently recruiting participants.
Verified January 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00953849
First received: August 4, 2009
Last updated: January 15, 2013
Last verified: January 2013
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Purpose
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 lessens the immune inhibitory environment while maturing cells that can stimulate T cell reactivity against oral cancer cells.
| Condition | Intervention | Phase |
|---|---|---|
|
Mouth Neoplasms |
Drug: 1,25-dihydroxyvitamin D3 Drug: celecoxib Drug: 1,25-dihydroxyvitamin D3 + celecoxib |
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: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953849
Contacts
| Contact: Judith Skoner, MD | (843) 789-7330 | skonerjm@musc.edu |
Locations
| 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 skonerjm@musc.edu | |
| Principal Investigator: M. Rita I Young, PhD | |
Sponsors and Collaborators
Investigators
| 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 |
| ClinicalTrials.gov Identifier: | NCT00953849 History of Changes |
| Other Study ID Numbers: | CLIN-003-09S |
| Study First Received: | August 4, 2009 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Calcitriol Celecoxib Immunotherapy |
Additional relevant MeSH terms:
|
Neoplasms Mouth Neoplasms Head and Neck Neoplasms Neoplasms by Site Mouth Diseases Stomatognathic Diseases Calcitriol Dihydroxycholecalciferols Vitamin D Vitamins Celecoxib Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013