Trial Outcomes & Findings for Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity (NCT NCT00953849)
NCT ID: NCT00953849
Last Updated: 2017-03-07
Results Overview
Change in IL-2 stimulatory cytokine levels within tumor tissue.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
baseline and 3 weeks
Results posted on
2017-03-07
Participant Flow
Participant milestones
| Measure |
Arm 1: Celecoxib
Treatment with Celecoxib
|
Arm 2: Calcitriol
Treatment with Calcitriol
|
Arm 3: Celecoxib Plus Calcitriol
Treatment with Celecoxib + Calcitriol
|
Arm 4: No Treatment
no treatment prior to surgery
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
4
|
5
|
|
Overall Study
COMPLETED
|
6
|
6
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
Baseline characteristics by cohort
| Measure |
Arm 1: Celecoxib
n=6 Participants
Celecoxib:
Celecoxib (400 mg twice daily) oral cancer patients receiving new immunotherapy prior to surgery
|
Arm 2: Calcitriol
n=6 Participants
Calcitriol Calcitriol (1,25-dihydroxyvitamin D3): 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment)
|
Arm 3: Celecoxib Plus Calcitriol
n=4 Participants
Celecoxib + Calcitriol 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg 1,25-dihydroxyvitamin D3) for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)
|
Arm 4: No Treatment
n=5 Participants
oral cancer patients receiving no immunotherapy prior to surgery
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
15 Participants
n=146 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
4 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
17 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: baseline and 3 weeksPopulation: Patients with head and neck squamous cell carcinoma.
Change in IL-2 stimulatory cytokine levels within tumor tissue.
Outcome measures
| Measure |
Arm 1: Celecoxib
n=6 Participants
Celecoxib treatment prior to surgery
Celecoxib: Celecoxib (400 mg twice daily)
|
Arm 2: Calcitriol
n=6 Participants
Treatment with Calcitriol prior to surgery
Calcitriol: 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)
|
Arm 3: Celecoxib Plus Calcitriol
n=4 Participants
Treatment with Celecoxib plus Calcitriol prior to surgery.
Celecoxib plus Calcitriol: 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)
|
Arm 4: No Treatment
n=5 Participants
no treatment prior to surgery
|
|---|---|---|---|---|
|
Change in IL-2 Levels
|
1.8 pg/100 gm protein
Standard Error 0.3
|
4.0 pg/100 gm protein
Standard Error 0.4
|
7.9 pg/100 gm protein
Standard Error 1.2
|
2.1 pg/100 gm protein
Standard Error 0.2
|
PRIMARY outcome
Timeframe: baseline and 3 weeksPopulation: Patients with head and neck squamous cell carcinoma.
Change in IFN-gamma stimulatory cytokine levels within tumor tissue.
Outcome measures
| Measure |
Arm 1: Celecoxib
n=6 Participants
Celecoxib treatment prior to surgery
Celecoxib: Celecoxib (400 mg twice daily)
|
Arm 2: Calcitriol
n=6 Participants
Treatment with Calcitriol prior to surgery
Calcitriol: 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)
|
Arm 3: Celecoxib Plus Calcitriol
n=4 Participants
Treatment with Celecoxib plus Calcitriol prior to surgery.
Celecoxib plus Calcitriol: 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)
|
Arm 4: No Treatment
n=5 Participants
no treatment prior to surgery
|
|---|---|---|---|---|
|
Change in IFN-gamma Levels
|
1.9 pg/100 gm protein
Standard Error 0.6
|
2.8 pg/100 gm protein
Standard Error 1.1
|
6.3 pg/100 gm protein
Standard Error 2.2
|
2.0 pg/100 gm protein
Standard Error 0.3
|
PRIMARY outcome
Timeframe: baseline and 3 weeksPopulation: Patients with head and neck squamous cell carcinoma.
Change in GM-CSF stimulatory cytokine levels within tumor tissue.
Outcome measures
| Measure |
Arm 1: Celecoxib
n=6 Participants
Celecoxib treatment prior to surgery
Celecoxib: Celecoxib (400 mg twice daily)
|
Arm 2: Calcitriol
n=6 Participants
Treatment with Calcitriol prior to surgery
Calcitriol: 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)
|
Arm 3: Celecoxib Plus Calcitriol
n=4 Participants
Treatment with Celecoxib plus Calcitriol prior to surgery.
Celecoxib plus Calcitriol: 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)
|
Arm 4: No Treatment
n=5 Participants
no treatment prior to surgery
|
|---|---|---|---|---|
|
Change in GM-CSF
|
3.8 pg/100 gm protein
Standard Error 1.4
|
8.1 pg/100 gm protein
Standard Error 1.9
|
14.3 pg/100 gm protein
Standard Error 3.4
|
3.2 pg/100 gm protein
Standard Error 0.9
|
PRIMARY outcome
Timeframe: baseline and 3 weeksPopulation: Patients with head and neck squamous cell carcinoma.
Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.
Outcome measures
| Measure |
Arm 1: Celecoxib
n=6 Participants
Celecoxib treatment prior to surgery
Celecoxib: Celecoxib (400 mg twice daily)
|
Arm 2: Calcitriol
n=6 Participants
Treatment with Calcitriol prior to surgery
Calcitriol: 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)
|
Arm 3: Celecoxib Plus Calcitriol
n=4 Participants
Treatment with Celecoxib plus Calcitriol prior to surgery.
Celecoxib plus Calcitriol: 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)
|
Arm 4: No Treatment
n=5 Participants
no treatment prior to surgery
|
|---|---|---|---|---|
|
Change in IL-6 Levels.
|
39 pg/100 gm protein
Standard Error 18
|
46 pg/100 gm protein
Standard Error 21
|
29 pg/100 gm protein
Standard Error 8
|
132 pg/100 gm protein
Standard Error 46
|
Adverse Events
Arm 1: Celecoxib
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: Calcitriol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Celecoxib Plus Calcitriol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 4: No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
M. Rita I. Young, Ph.D.
Ralph H. Johnson VA Medical Center, Charleston, SC
Phone: 843-792-9953
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place