Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity

NCT00953849 | Completed Phase 1 Results DMC

• 1 other identifier: CLIN-003-09S
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mouth Neoplasms

Keywords

Calcitriol; Celecoxib; Immunotherapy

Outcome Measures

Primary Outcomes (4)

• Change in IL-2 Levels

  Change in IL-2 stimulatory cytokine levels within tumor tissue.

  baseline and 3 weeks

• Change in IFN-gamma Levels

  Change in IFN-gamma stimulatory cytokine levels within tumor tissue.

  baseline and 3 weeks

• Change in GM-CSF

  Change in GM-CSF stimulatory cytokine levels within tumor tissue.

  baseline and 3 weeks

• Change in IL-6 Levels.

  Change in levels of immune inhibitory/inflammatory mediator IL-6 in tumor tissue.

  baseline and 3 weeks

Study Arms (4)

Arm 1: Celecoxib

EXPERIMENTAL

Celecoxib treatment prior to surgery

Drug: Celecoxib

Arm 2: Calcitriol

EXPERIMENTAL

Treatment with Calcitriol prior to surgery

Drug: Calcitriol

Arm 3: Celecoxib plus Calcitriol

EXPERIMENTAL

Treatment with Celecoxib plus Calcitriol prior to surgery.

Drug: Celecoxib plus Calcitriol

Arm 4: No Treatment

NO INTERVENTION

no treatment prior to surgery

Interventions

Celecoxib DRUG

Celecoxib (400 mg twice daily)

Also known as: Celebrex

Arm 1: Celecoxib

Calcitriol DRUG

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)

Also known as: 1,25-dihydroxyvitamin D3

Arm 2: Calcitriol

Celecoxib plus Calcitriol DRUG

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)

Also known as: 1,25-dihydroxyvitamin D3

Arm 3: Celecoxib plus Calcitriol

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

Celecoxib; Calcitriol

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

Difficulty in recruiting subjects that are eligible for the combination Celecoxib + Calcitriol treatment.

Results Point of Contact

• Title: M. Rita I. Young, Ph.D.
• Organization: Ralph H. Johnson VA Medical Center, Charleston, SC

rita.young@va.gov

843-792-9953

Study Officials

• M. Rita I Young, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 7, 2017
• Results First Posted: December 21, 2016

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)