Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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 cancer patients which lessen the immune inhibitory environment while maturing cells that can stimulate T cell reactivity against oral cancer cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Treatments: Calcitriol; Celecoxib; Dihydroxycholecalciferols; Vitamin D

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

• 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