Status:
COMPLETED
Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
Lead Sponsor:
VA Office of Research and Development
Conditions:
Mouth Neoplasms
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
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 inductio...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00953849
Start Date
November 1 2009
End Date
December 1 2015
Last Update
March 7 2017
Active Locations (1)
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1
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799