Trial · NCT00953849
Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
NCT00953849, Phase 1, Phase 2, Completed, VA Office of Research and Development; results first posted 2016-12-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity. Trials, record NCT00953849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00953849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
- NCT number
- NCT00953849
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 21 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Mouth Neoplasms
- Interventions
- Celecoxib, Calcitriol, Celecoxib plus Calcitriol
- First posted
- 2009-08-06
- Last updated
- 2017-03-07
- Results first posted
- 2016-12-21
- Limitations and caveats
- Difficulty in recruiting subjects that are eligible for the combination Celecoxib + Calcitriol treatment.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in IL-2 Levels | baseline and 3 weeks | Change in IL-2 stimulatory cytokine levels within tumor tissue. |
| Primary | Change in IFN-gamma Levels | baseline and 3 weeks | Change in IFN-gamma stimulatory cytokine levels within tumor tissue. |
| Primary | Change in GM-CSF | baseline and 3 weeks | Change in GM-CSF stimulatory cytokine levels within tumor tissue. |
| Primary | Change in IL-6 Levels. | baseline and 3 weeks | Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in IL-2 Levels | baseline and 3 weeks | Patients with head and neck squamous cell carcinoma. | pg/100 gm protein | MEAN |
| PRIMARY | Change in IFN-gamma Levels | baseline and 3 weeks | Patients with head and neck squamous cell carcinoma. | pg/100 gm protein | MEAN |
| PRIMARY | Change in GM-CSF | baseline and 3 weeks | Patients with head and neck squamous cell carcinoma. | pg/100 gm protein | MEAN |
| PRIMARY | Change in IL-6 Levels. | baseline and 3 weeks | Patients with head and neck squamous cell carcinoma. | pg/100 gm protein | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in IL-2 Levels | Arm 1: Celecoxib | 1.8 | Standard Error 0.3 | pg/100 gm protein | |
| Change in IL-2 Levels | Arm 2: Calcitriol | 4.0 | Standard Error 0.4 | pg/100 gm protein | |
| Change in IL-2 Levels | Arm 3: Celecoxib Plus Calcitriol | 7.9 | Standard Error 1.2 | pg/100 gm protein | |
| Change in IL-2 Levels | Arm 4: No Treatment | 2.1 | Standard Error 0.2 | pg/100 gm protein | |
| Change in IFN-gamma Levels | Arm 1: Celecoxib | 1.9 | Standard Error 0.6 | pg/100 gm protein | |
| Change in IFN-gamma Levels | Arm 2: Calcitriol | 2.8 | Standard Error 1.1 | pg/100 gm protein | |
| Change in IFN-gamma Levels | Arm 3: Celecoxib Plus Calcitriol | 6.3 | Standard Error 2.2 | pg/100 gm protein | |
| Change in IFN-gamma Levels | Arm 4: No Treatment | 2.0 | Standard Error 0.3 | pg/100 gm protein | |
| Change in GM-CSF | Arm 1: Celecoxib | 3.8 | Standard Error 1.4 | pg/100 gm protein | |
| Change in GM-CSF | Arm 2: Calcitriol | 8.1 | Standard Error 1.9 | pg/100 gm protein |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1: Celecoxib | 6 | |
| Overall Study | STARTED | Arm 2: Calcitriol | 6 | |
| Overall Study | STARTED | Arm 3: Celecoxib Plus Calcitriol | 4 | |
| Overall Study | STARTED | Arm 4: No Treatment | 5 | |
| Overall Study | COMPLETED | Arm 1: Celecoxib | 6 | |
| Overall Study | COMPLETED | Arm 2: Calcitriol | 6 | |
| Overall Study | COMPLETED | Arm 3: Celecoxib Plus Calcitriol | 4 | |
| Overall Study | COMPLETED | Arm 4: No Treatment | 5 | |
| Overall Study | NOT COMPLETED | Arm 1: Celecoxib | 0 | |
| Overall Study | NOT COMPLETED | Arm 2: Calcitriol | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1: Celecoxib | ||
| Total, all-cause mortality | Arm 2: Calcitriol | ||
| Total, all-cause mortality | Arm 3: Celecoxib Plus Calcitriol | ||
| Total, all-cause mortality | Arm 4: No Treatment | ||
| Total, other adverse events | Arm 1: Celecoxib | 0 | 6 |
| Total, other adverse events | Arm 2: Calcitriol | 0 | 6 |
| Total, other adverse events | Arm 3: Celecoxib Plus Calcitriol | 0 | 4 |
| Total, other adverse events | Arm 4: No Treatment | 0 | 5 |
| Total, serious adverse events | Arm 1: Celecoxib | 0 | 6 |
| Total, serious adverse events | Arm 2: Calcitriol | 0 | 6 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00953849
GET https://conductscience.org/api/trials/v1/NCT00953849/registered