Phase 2 N=21 Randomized Basic Science

Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity

Mouth Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00953849 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcome: Primary: Change in IL-2 Levels — 1.8; 4.0; 7.9; 2.1 pg/100 gm protein — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Celecoxib (Drug); Calcitriol (Drug); Celecoxib plus Calcitriol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in IL-2 Levels	1.8; 4.0; 7.9; 2.1	<0.05 sig
PRIMARY Change in IFN-gamma Levels	1.9; 2.8; 6.3; 2.0	<0.05 sig
PRIMARY Change in GM-CSF	3.8; 8.1; 14.3; 3.2	<0.05 sig
PRIMARY Change in IL-6 Levels.	39; 46; 29; 132	<0.05 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00953849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.