Non-Small-Cell Lung CarcinomaPhase 1NCT00108186
Celecoxib Treatment for Lung Cancer
A Phase 1 study testing Celecoxib in people with Non-Small-Cell Lung Carcinoma, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy
Who cannot join
- Hypersensitivity to celecoxib or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
About this study
Official title: Celecoxib-Mediated Inhibition of T Regulatory Cells in Human Lung Cancer
This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of COX-2 inhibitors in prevention and therapy for lung cancer.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- Celecoxib
- Keywords
- cyclooxygenase 2, lung cancer, lymphocytes, non small cell, therapeutics
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Eight subjects will be assigned to one of three cohorts. Subjects will receive Celecoxib in escalating doses per cohort, starting with 200mg twice a day by mouth; 400mg twice a day by mouth; and increasing to 600mg twice a day by mouth, for a total of 7 days. Subjects will have blood taken before the start of Celecoxib, and after completion of 7-days of Celecoxib.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Celecoxib is an FDA approved drug for other indications such as osteoarthritis. It is not FDA approved for non-small cell lung cancer. Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure bio-markers; safety measures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2005 (estimated)
- Study startOct 2004
- Primary completionJun 2010
- Study completionJun 2011
Why it stopped: Couldn't accrue patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven Dubinett, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West LA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00108186
- Sponsor's protocol ID
- ONCA-043-04S
- Status last verified
- Oct 2014
- First submitted
- 14 Apr 2005
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celecoxib-Mediated Inhibition of T Regulatory Cells in Human Lung Cancer
- ClinicalTrials.gov ID
- NCT00108186
- Acronym / sponsor ID
- ONCA-043-04S
- Conditions
- Non-Small-Cell Lung Carcinoma
- Keywords
- cyclooxygenase 2, lung cancer, lymphocytes, non small cell, therapeutics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Couldn't accrue patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of California, Los Angeles, City of Hope Medical Center
- Study start
- Oct 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal evaluates cyclooxygenase 2 (COX-2) inhibition as a means to decrease T regulatory cell activities and thus augment immune responses against lung cancer. The broad goal focuses on understanding how COX-2 expression regulates the malignant phenotype in non small cell lung cancer in an effort to foster an informed approach for the use of COX-2 inhibitors in prevention and therapy for lung cancer.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Drug: CelecoxibCelecoxib is an FDA approved drug for other indications such as osteoarthritis. It is not FDA approved for non-small cell lung cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pathologically confirmed and surgically resectable non small cell lung cancer and subjects must be ineligible for or refuse, neoadjuvant therapy
Key exclusion criteria (1 listed)
- Hypersensitivity to celecoxib or NSAIDs, previous history of GI bleeding or ulceration, chronic or concurrent use of steroids and renal insufficiency
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 |
|---|---|---|
| CelecoxibEight subjects will be assigned to one of three cohorts. Subjects will receive Celecoxib in escalating doses per cohort, starting with 200mg twice a day by mouth; 400mg twice a day by mouth; and increasing to 600mg twice a day by mouth, for a total of 7 days. Subjects will have blood taken before the start of Celecoxib, and after completion of 7-days of Celecoxib. | Drug | Arm 1 |
Primary outcome
Measure bio-markers; safety measures
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
Related trials for Non-Small-Cell Lung Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Steven Dubinett, MD principal investigator
VA Greater Los Angeles Healthcare System, West LA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Celecoxib in people with Non-Small-Cell Lung Carcinoma, run by US Department of Veterans Affairs 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Oct 2014. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Measure bio-markers; safety measures (time frame: 2 years). 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 29 Oct 2014.