Clinical trial · Interventional
Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
NCT00953849CI-TRIAL-00026338completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcitriol | Drug | — | UNRESOLVED |
| Celecoxib | Drug | Celecoxib | ALIAS |
| Celecoxib plus Calcitriol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1: Celecoxib
- description
- Celecoxib treatment prior to surgery
- interventionNames
- Drug: Celecoxib
- type
- EXPERIMENTAL
- label
- Arm 2: Calcitriol
- description
- Treatment with Calcitriol prior to surgery
- interventionNames
- Drug: Calcitriol
- type
- EXPERIMENTAL
- label
- Arm 3: Celecoxib plus Calcitriol
- description
- Treatment with Celecoxib plus Calcitriol prior to surgery.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.