CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Celecoxib +2 moredrug
Likely dose
Celecoxib 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00953849
NCT00953849Phase 2Completed
CompareCT.gov

Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity

VA Office of Research and Development·interventional·Posted Aug 6, 2009·Updated Mar 7, 2017

In Brief

A Phase 2 clinical trial evaluating Celecoxib, Calcitriol, and 1 other intervention for Mouth Neoplasms. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMouth Neoplasms
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartNov 1, 2009
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 16.9 years ago

Interventions

Celecoxibdrug

Celecoxib (400 mg twice daily)

Calcitrioldrug

3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment)

Celecoxib plus Calcitrioldrug

3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)