Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity

Completed · Phase 1/Phase 2

Conditions studied: Mouth Neoplasms

In brief

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.

Key facts

Study ID

NCT00953849

Run by

VA Office of Research and Development

People needed

21

Starts

2009-11-01

Expected to finish

2015-12-01

Last updated by the study team

2017-03-07

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.