Non-melanomatous Skin CancerPhase 2NCT00025051
Celecoxib in Preventing Skin Cancer
A Phase 2 study testing celecoxib, anti-cytokine therapy and antiangiogenesis therapy in people with Non-melanomatous Skin Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not yet known whether celecoxib is more effective than a placebo in preventing skin cancer. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Non-melanomatous Skin Cancer
- What is being tested?
- celecoxib, anti-cytokine therapy and antiangiogenesis therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Fitzpatrick type I-IV skin
- No history of photosensitivity (e.g., systemic or discoid lupus erythematosus, polymorphous light eruption, or photocontact dermatitis)
- No history of abnormal tanning responses or other unusual reactions to natural or artificial light sources
- Willing to wear sun-protective clothing and SPF 15-49 sunscreen
- Willing and able to restrict the frequency of high ultraviolet-exposure activities (e.g., exposure to sunlight, tanning boxes, or other artificial light sources)
- No history of keloid formation
PATIENT CHARACTERISTICS:
Age:
- 20 to 60
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC ≥ 3,500/mm^3
- Hemoglobin ≥ 12.0 g/dL
- No bleeding disorder
Hepatic:
- Bilirubin ≤ 20% above upper limit of normal (ULN)
- AST and ALT ≤ 20% above ULN
- No chronic or acute hepatic disease
Renal:
- Creatinine ≤ 20% above ULN
- No chronic or acute renal disease
Gastrointestinal:
- No active gastrointestinal disease (e.g., inflammatory bowel disease)
- No pancreatic disease
- No esophageal, gastric, pyloric channel, or duodenal ulceration
Other:
- No invasive cancer except nonmelanoma skin cancer cured by excision or stage I cervical cancer
- No hypersensitivity or adverse reactions to NSAIDs, salicylates, cyclo-oxygenase-2 (COX-2) inhibitors, or sulfonamides
- No condition that would preclude the use of NSAIDs
- No clinically significant laboratory abnormalities
- No medical or psychosocial condition that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile participants must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent chemo-immunotherapy
Chemotherapy:
- See Biologic therapy
- At least 1 year since prior chemotherapy, including topical fluorouracil
Endocrine therapy:
- At least 2 weeks since prior topical glucocorticoids
- At least 30 days since prior systemic corticosteroids
- No concurrent systemic glucocorticoids (inhaled corticosteroids allowed)
- No concurrent topical corticosteroids
- No concurrent hormonal therapy
- Hormone replacement (e.g., estrogen or thyroid replacement) allowed
Radiotherapy:
- No concurrent radiotherapy
Surgery:
- Not specified
Other:
- At least 14 days since prior aspirin (> 100 mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) taken at least 3 times per week
- At least 2 weeks since prior topical alpha hydroxy acids (e.g., glycolic acid or lactic acid)
- At least 6 months since prior oral retinoids (3 months for topical retinoids to the face)
- At least 30 days since prior treatment for esophageal, gastric, pyloric channel, or duodenal ulceration
- At least 30 days since prior investigational medication
- No other concurrent investigational medication
- No concurrent topical vitamin A derivatives and/or alpha hydroxy acids
- No concurrent immunosuppressive drugs
- No concurrent topical medication to the skin, including prescription and over-the-counter preparations (moisturizers and emollients allowed)
- No concurrent lithium, fluconazole, or warfarin
- No concurrent chronic NSAIDs (> 3 times per week for > 2 consecutive weeks per year)
- Concurrent cardioprotective doses of aspirin (≤ 100 mg/day) allowed
- Concurrent acetaminophen allowed
- No concurrent green tea consumption of > 2 cups per day
Trial locations and contacts
1 site in 1 country.
United States1 site
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
About this study
Official title: A Phase II, Double-Blind, Placebo-Controlled Clinical Trial To Assess Celecoxib As A Chemopreventive Agent Inhibiting UV-Induced Erythema And Cutaneous Carcinogenesis As Assessed Through Surrogate Biological Markers In Biopsied Skin After Exposure Of Skin In Normal Volunteers Ages 20-60 Years Old With Fitzpatrick Type I, II, III And IV Skin To UV-Radiation From Artificial Light Sources
RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not yet known whether celecoxib is more effective than a placebo in preventing skin cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light.
Read the detailed description
OBJECTIVES:
- Determine whether celecoxib decreases ultraviolet(UV)-induced erythema and affects surrogate biomarkers of potential neoplastic change in participants with Fitzpatrick type I-IV skin exposed to UV light.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are randomized to one of two treatment arms.
- Arm I: Participants receive oral celecoxib twice daily for approximately 120 days.
- Arm II: Participants receive oral placebo twice daily for approximately 120 days.
Skin biopsies of UV-exposed sites are evaluated.
Participants are followed for up to 5 weeks post-treatment.
PROJECTED ACCRUAL: A total of 36 participants (18 per arm) will be accrued for this study within 8 months.
- Conditions
- Non-melanomatous Skin Cancer
- Being tested
- celecoxib, anti-cytokine therapy, antiangiogenesis therapy, biological therapy, cancer prevention intervention
- Keywords
- basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
anti-cytokine therapyProcedure or surgery
antiangiogenesis therapyProcedure or surgery
biological therapyProcedure or surgery
cancer prevention interventionProcedure or surgery
chemoprevention of cancerProcedure or surgery
growth factor antagonist therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-melanomatous Skin CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- David R. Bickers, MD, Study chair, Herbert Irving Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00025051
- Sponsor's protocol ID
- CDR0000068840
- Other IDs
- CPMC-U19-CA81888-01-UV, CPMC-IRB-9923, NCI-P01-0191
- Status last verified
- Dec 2006
- First submitted
- 11 Oct 2001
- Last updated
- 22 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-Blind, Placebo-Controlled Clinical Trial To Assess Celecoxib As A Chemopreventive Agent Inhibiting UV-Induced Erythema And Cutaneous Carcinogenesis As Assessed Through Surrogate Biological Markers In Biopsied Skin After Exposure Of Skin In Normal Volunteers Ages 20-60 Years Old With Fitzpatrick Type I, II, III And IV Skin To UV-Radiation From Artificial Light Sources
- ClinicalTrials.gov ID
- NCT00025051
- Acronym / sponsor ID
- CDR0000068840
- Conditions
- Non-melanomatous Skin Cancer
- Keywords
- basal cell carcinoma of the skin, squamous cell carcinoma of the skin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- First posted
- 27 Jan 2003 (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.
RATIONALE: Celecoxib may be effective in preventing skin cancer by decreasing redness caused by exposure to ultraviolet light and changing potential skin cancer biomarkers. It is not yet known whether celecoxib is more effective than a placebo in preventing skin cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light.
Detailed description
OBJECTIVES:
- Determine whether celecoxib decreases ultraviolet(UV)-induced erythema and affects surrogate biomarkers of potential neoplastic change in participants with Fitzpatrick type I-IV skin exposed to UV light.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Participants are randomized to one of two treatment arms.
- Arm I: Participants receive oral celecoxib twice daily for approximately 120 days.
- Arm II: Participants receive oral placebo twice daily for approximately 120 days.
Skin biopsies of UV-exposed sites are evaluated.
Participants are followed for up to 5 weeks post-treatment.
PROJECTED ACCRUAL: A total of 36 participants (18 per arm) will be accrued for this study within 8 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| celecoxib | Drug | – |
| anti-cytokine therapy | Procedure or surgery | – |
| antiangiogenesis therapy | Procedure or surgery | – |
| biological therapy | Procedure or surgery | – |
| cancer prevention intervention | Procedure or surgery | – |
| chemoprevention of cancer | Procedure or surgery | – |
| growth factor antagonist therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 22 Mar 2013.
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.
David R. Bickers, MD study chair
Herbert Irving Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing celecoxib, anti-cytokine therapy and antiangiogenesis therapy in people with Non-melanomatous Skin Cancer, run by National Cancer Institute (NCI) 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?
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 22 Mar 2013. 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 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?
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.
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 22 Mar 2013.