Mouth NeoplasmsPhase 1/2NCT00953849
Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
A Phase 1/2 study testing Celecoxib, Calcitriol and Celecoxib plus Calcitriol in people with Mouth Neoplasms, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Mouth Neoplasms
- What is being tested?
- Celecoxib, Calcitriol and Celecoxib plus Calcitriol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
About this study
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.
Read the detailed description
The hypothesis of this study is beneficial T cell reactivity in oral squamous cell carcinoma (OSCC) tumors can be synergistically stimulated by blocking suppressor endothelial cells and their induction of other inhibitory cell populations while also maturing immune inhibitory CD34+ cells into antigen-presenting dendritic cells.
To test this hypothesis, newly diagnosed OSCC patients will be administered the cyclooxigenase 2 inhibitor celecoxib and/or Calcitriol for the 3 week duration between cancer diagnosis and surgical treatment. The following aims will test the immunological and clinical effectiveness of the combination treatment:
- 1. To block the suppressive activity of endothelial cells and increase the levels of dendritic that are stimulatory to T cell reactivity, thereby synergistically increasing intratumoral T cell reactivity. These functional immune analyses will use OSCC tissues removed from untreated patients or patients treated with celecoxib and/or Calcitriol.
- 2. To reduce development of OSCC recurrences by synergistically stimulating intratumoral T cell reactivity with celecoxib to block suppressor endothelial cell activity and Calcitriol to mature CD34+ suppressor cells into T cell stimulatory dendritic cells.
- Conditions
- Mouth Neoplasms
- Being tested
- Celecoxib, Calcitriol, Celecoxib plus Calcitriol
- Keywords
- Calcitriol, Celecoxib, Immunotherapy
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Also called Celebrex
Celecoxib (400 mg twice daily)
CalcitriolDrug
Also called 1,25-dihydroxyvitamin D3
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
Also called 1,25-dihydroxyvitamin D3
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)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Celecoxib | Experimental | Celecoxib treatment prior to surgery Receives: Drug: Celecoxib |
| Arm 2: Calcitriol | Experimental | Treatment with Calcitriol prior to surgery Receives: Drug: Calcitriol |
| Arm 3: Celecoxib plus Calcitriol | Experimental | Treatment with Celecoxib plus Calcitriol prior to surgery. Receives: Drug: Celecoxib plus Calcitriol |
| Arm 4: No Treatment | No intervention | no treatment prior to surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IL-2 Levels
Change in IL-2 stimulatory cytokine levels within tumor tissue.
Measured: baseline and 3 weeks
Change in IFN-gamma Levels
Change in IFN-gamma stimulatory cytokine levels within tumor tissue.
Measured: baseline and 3 weeks
Change in GM-CSF
Change in GM-CSF stimulatory cytokine levels within tumor tissue.
Measured: baseline and 3 weeks
Change in IL-6 Levels.
Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mouth NeoplasmsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- M. Rita I Young, PhD, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953849
- Sponsor's protocol ID
- CLIN-003-09S
- Status last verified
- Jan 2017
- First submitted
- 4 Aug 2009
- Last updated
- 7 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Publication of deidentified results.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
- ClinicalTrials.gov ID
- NCT00953849
- Acronym / sponsor ID
- CLIN-003-09S
- Conditions
- Mouth Neoplasms
- Keywords
- Calcitriol, Celecoxib, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Nov 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 21 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The hypothesis of this study is beneficial T cell reactivity in oral squamous cell carcinoma (OSCC) tumors can be synergistically stimulated by blocking suppressor endothelial cells and their induction of other inhibitory cell populations while also maturing immune inhibitory CD34+ cells into antigen-presenting dendritic cells.
To test this hypothesis, newly diagnosed OSCC patients will be administered the cyclooxigenase 2 inhibitor celecoxib and/or Calcitriol for the 3 week duration between cancer diagnosis and surgical treatment. The following aims will test the immunological and clinical effectiveness of the combination treatment:
- 1. To block the suppressive activity of endothelial cells and increase the levels of dendritic that are stimulatory to T cell reactivity, thereby synergistically increasing intratumoral T cell reactivity. These functional immune analyses will use OSCC tissues removed from untreated patients or patients treated with celecoxib and/or Calcitriol.
- 2. To reduce development of OSCC recurrences by synergistically stimulating intratumoral T cell reactivity with celecoxib to block suppressor endothelial cell activity and Calcitriol to mature CD34+ suppressor cells into T cell stimulatory dendritic cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Celecoxib | Experimental | Drug: CelecoxibCelecoxib treatment prior to surgery |
| Arm 2: Calcitriol | Experimental | Drug: CalcitriolTreatment with Calcitriol prior to surgery |
| Arm 3: Celecoxib plus Calcitriol | Experimental | Drug: Celecoxib plus CalcitriolTreatment with Celecoxib plus Calcitriol prior to surgery. |
| Arm 4: No Treatment | No intervention | –no treatment prior to surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- prior immunotherapy
- chemotherapy or radiation therapy within three weeks
- concurrent NSAID treatments while undergoing treatment
- women pregnant or lactating
- HIV positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelecoxibAlso: CelebrexCelecoxib (400 mg twice daily) | Drug | Arm 1: Celecoxib |
| CalcitriolAlso: 1,25-dihydroxyvitamin D33 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) | Drug | Arm 2: Calcitriol |
| Celecoxib plus CalcitriolAlso: 1,25-dihydroxyvitamin D33 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) | Drug | Arm 3: Celecoxib plus Calcitriol |
Primary outcome
Change in IL-2 Levels
Time frame: baseline and 3 weeks
Change in IL-2 stimulatory cytokine levels within tumor tissue.
Change in IFN-gamma Levels
Time frame: baseline and 3 weeks
Change in IFN-gamma stimulatory cytokine levels within tumor tissue.
Change in GM-CSF
Time frame: baseline and 3 weeks
Change in GM-CSF stimulatory cytokine levels within tumor tissue.
Change in IL-6 Levels.
Time frame: baseline and 3 weeks
Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Publication of deidentified results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Rita I Young, PhD principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Celecoxib, Calcitriol and Celecoxib plus Calcitriol in people with Mouth Neoplasms, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IL-2 Levels (time frame: baseline and 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2017.