Phase 2
Completed N=21
Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
Source: ClinicalTrials.gov NCT00953849 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Change in IL-2 Levels — 1.8; 4.0; 7.9; 2.1 pg/100 gm protein — p=<0.05
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.
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 |
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
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. Informational only — not medical advice.