- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00025051
Celecoxib in Preventing Skin Cancer
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Phase
- Phase 2
Kontakte und Standorte
Studienorte
-
-
New York
-
New York, New York, Vereinigte Staaten, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Maskierung: Doppelt
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: David R. Bickers, MD, Herbert Irving Comprehensive Cancer Center
Studienaufzeichnungsdaten
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Hautkrankheiten
- Neubildungen
- Neubildungen nach Standort
- Hauttumoren
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Agenten des peripheren Nervensystems
- Enzym-Inhibitoren
- Analgetika
- Agenten des sensorischen Systems
- Entzündungshemmende Mittel, nichtsteroidal
- Analgetika, nicht narkotisch
- Entzündungshemmende Mittel
- Antirheumatika
- Cyclooxygenase-Inhibitoren
- Mitose-Modulatoren
- Cyclooxygenase-2-Inhibitoren
- Celecoxib
- Mitogene
Andere Studien-ID-Nummern
- CDR0000068840
- CPMC-U19-CA81888-01-UV
- CPMC-IRB-9923
- NCI-P01-0191
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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