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Trial record 82 of 11840 for:    Oral Cancer

Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity

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ClinicalTrials.gov Identifier: NCT00953849
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : December 21, 2016
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Mouth Neoplasms
Interventions Drug: Celecoxib
Drug: Calcitriol
Drug: Celecoxib plus Calcitriol
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment
Hide Arm/Group Description Treatment with Celecoxib Treatment with Calcitriol Treatment with Celecoxib + Calcitriol no treatment prior to surgery
Period Title: Overall Study
Started 6 6 4 5
Completed 6 6 4 5
Not Completed 0 0 0 0
Arm/Group Title Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment Total
Hide Arm/Group Description

Celecoxib:

Celecoxib (400 mg twice daily) oral cancer patients receiving new immunotherapy prior to surgery

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) 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) oral cancer patients receiving no immunotherapy prior to surgery Total of all reporting groups
Overall Number of Baseline Participants 6 6 4 5 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 4 participants 5 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
  66.7%
4
  66.7%
3
  75.0%
4
  80.0%
15
  71.4%
>=65 years
2
  33.3%
2
  33.3%
1
  25.0%
1
  20.0%
6
  28.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 4 participants 5 participants 21 participants
Female
0
   0.0%
3
  50.0%
1
  25.0%
0
   0.0%
4
  19.0%
Male
6
 100.0%
3
  50.0%
3
  75.0%
5
 100.0%
17
  81.0%
1.Primary Outcome
Title Change in IL-2 Levels
Time Frame baseline and 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with head and neck squamous cell carcinoma.
Arm/Group Title Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment
Hide Arm/Group Description:

Celecoxib treatment prior to surgery

Celecoxib: Celecoxib (400 mg twice daily)

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)

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)

no treatment prior to surgery
Overall Number of Participants Analyzed 6 6 4 5
Mean (Standard Error)
Unit of Measure: pg/100 gm protein
1.8  (0.3) 4.0  (0.4) 7.9  (1.2) 2.1  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Celecoxib, Arm 2: Calcitriol, Arm 3: Celecoxib Plus Calcitriol, Arm 4: No Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments A Student's t test was performed to determine significance of differences between each of two groups.
2.Primary Outcome
Title Change in IFN-gamma Levels
Time Frame baseline and 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with head and neck squamous cell carcinoma.
Arm/Group Title Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment
Hide Arm/Group Description:

oral cancer patients receiving new immunotherapy prior to surgery

1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)

oral cancer patients receiving new immunotherapy prior to surgery

celecoxib: celecoxib (400 mg twice daily)

oral cancer patients receiving new immunotherapy prior to surgery

1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)

oral cancer patients receiving no immunotherapy prior to surgery
Overall Number of Participants Analyzed 6 6 4 5
Mean (Standard Error)
Unit of Measure: pg/100 gm protein
1.9  (0.6) 2.8  (1.1) 6.3  (2.2) 2.0  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Celecoxib, Arm 2: Calcitriol, Arm 3: Celecoxib Plus Calcitriol, Arm 4: No Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments A Student’s t test was performed to determine significance of differences between each of two groups.
3.Primary Outcome
Title Change in GM-CSF
Time Frame baseline and 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with head and neck squamous cell carcinoma.
Arm/Group Title Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment
Hide Arm/Group Description:

oral cancer patients receiving new immunotherapy prior to surgery

1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)

oral cancer patients receiving new immunotherapy prior to surgery

celecoxib: celecoxib (400 mg twice daily)

oral cancer patients receiving new immunotherapy prior to surgery

1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)

oral cancer patients receiving no immunotherapy prior to surgery
Overall Number of Participants Analyzed 6 6 4 5
Mean (Standard Error)
Unit of Measure: pg/100 gm protein
3.8  (1.4) 8.1  (1.9) 14.3  (3.4) 3.2  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Celecoxib, Arm 2: Calcitriol, Arm 3: Celecoxib Plus Calcitriol, Arm 4: No Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments A Student’s t test was performed to determine significance of differences between each of two groups.
4.Primary Outcome
Title Change in IL-6 Levels.
Hide Description Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.
Time Frame baseline and 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with head and neck squamous cell carcinoma.
Arm/Group Title Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment
Hide Arm/Group Description:

oral cancer patients receiving new immunotherapy prior to surgery

1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)

oral cancer patients receiving new immunotherapy prior to surgery

celecoxib: celecoxib (400 mg twice daily)

oral cancer patients receiving new immunotherapy prior to surgery

1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)

oral cancer patients receiving no immunotherapy prior to surgery
Overall Number of Participants Analyzed 6 6 4 5
Mean (Standard Error)
Unit of Measure: pg/100 gm protein
39  (18) 46  (21) 29  (8) 132  (46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Celecoxib, Arm 2: Calcitriol, Arm 3: Celecoxib Plus Calcitriol, Arm 4: No Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments A Student’s t test was performed to determine significance of differences between each of two groups.
Time Frame 3 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment
Hide Arm/Group Description oral cancer patients receiving Celecoxib prior to surgery oral cancer patients receiving Calcitriol prior to surgery oral cancer patients receiving Celecoxib + Calcitriol prior to surgery oral cancer patients receiving no treatment prior to surgery
All-Cause Mortality
Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/4 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Celecoxib Arm 2: Calcitriol Arm 3: Celecoxib Plus Calcitriol Arm 4: No Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/4 (0.00%)   0/5 (0.00%) 
Difficulty in recruiting subjects that are eligible for the combination Celecoxib + Calcitriol treatment.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: M. Rita I. Young, Ph.D.
Organization: Ralph H. Johnson VA Medical Center, Charleston, SC
Phone: 843-792-9953
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00953849     History of Changes
Other Study ID Numbers: CLIN-003-09S
First Submitted: August 4, 2009
First Posted: August 6, 2009
Results First Submitted: September 6, 2016
Results First Posted: December 21, 2016
Last Update Posted: March 7, 2017