- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00841204
Sulindac in Preventing Melanoma in Healthy Participants Who Are at Increased Risk of Melanoma
Phase II Trial of Sulindac in Individuals at Increased Risk for Melanoma
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVE:
I. To determine sulindac and metabolite levels in healthy participants with atypical nevi and benign nevus at increased risk for melanoma treated with sulindac versus placebo.
SECONDARY OBJECTIVES:
I. To assess the effects of sulindac on apoptosis in atypical nevi of these participants.
II. To assess the effects of sulindac on VEGF expression in atypical nevi of these participants.
III. To assess sulindac and metabolite levels in plasma and its association with drug levels in the target tissue.
OUTLINE: This is a multicenter study. Participants are randomized to 1 of 2 treatment arms.
ARM I: Participants receive oral sulindac twice daily.
ARM II: Participants receive oral placebo twice daily.
In both arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.
Blood and tissue samples are collected at baseline and/or after completion of study therapy and analyzed for sulindac and metabolite levels via high performance liquid chromatography tandem mass spectrometry; the detection of apoptotic cells via TUNEL assay; and VEGF expression via immunohistochemistry assays.
After completion of study therapy, participants are followed for 2 weeks.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Arizona
-
Tucson, Arizona, Forenede Stater, 85724
- University of Arizona Health Sciences Center
-
-
California
-
Stanford, California, Forenede Stater, 94305
- Stanford University Hospitals and Clinics
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Criteria:
- Healthy participants at risk for developing melanoma and meeting the following criteria: must have >= 4 large (>= 5 mm and < 15 mm) atypical nevi and have 1 benign nevus amenable to biopsies
- No histologically confirmed melanoma on the baseline biopsy
- No more than 1 prior cutaneous melanoma
- One prior stage I, IIA, or IIB melanoma allowed provided patients have been off treatment > 3 months
- Modified dermoscopy score < 4.8
- Karnofsky performance status 80-100%
- ANC >= 1,500/mm^3
- No family history of melanoma involving >= 2 first degree relatives
- Platelets count >= 100,000/mm^3
- Total bilirubin =< 2.0 mg/dL
- AST/ALT =< 2.0 times upper limit of normal
- Creatinine =< 1.5 mg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception
- More than 6 months since prior and no concurrent tanning bed use or other methods to promote sun-tanning
- Willing to minimize sunlight exposure by applying sunscreen/sunblock or wearing clothing to shield skin during outdoor activity during study participation
- Willing or able to limit alcohol consumption to less than 3 servings a week during the study period
- No frequent, chronic or moderate/severe gastrointestinal (GI) complaints
- Upper GI problems requiring prescription or nonprescription medical remedies for symptoms of heartburn, dyspepsia, nausea, or abdominal pain > once a week on average
- History of peptic ulcer, occult or gross intestinal bleeding
- No prior allergic reaction to aspirin (unless subsequent dosing with other NSAIDs has been well tolerated)
- No history of allergic reaction to lidocaine or xylocaine
- No history of allergic reaction (e.g., urticaria, asthma, or rhinitis) or gastric intolerance attributed to compounds of similar chemical or biological composition to sulindac
- No invasive cancer or cancer treatment within the past 5 years, except nonmelanoma skin cancer
- No immunosuppression by medication or disease, including any of the following: AIDS, oral prednisone, immunosuppressant/immunomodulator (i.e., cyclosporine, chemotherapeutic agent, or biologic therapy)
- No uncontrolled intercurrent illness
- No ongoing or active infection
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No psychiatric illness/social situations that would limit compliance with study requirements
- At least 30 days since prior participation and no concurrent enrollment or planning to enroll in another clinical trial
- No NSAIDs for more than 5 days per month within the past 3 months and no concurrent non-study NSAIDs, except low dose aspirin (81 mg/day)
- Willing or able to refrain from herbal medicines, above-standard vitamins, or minerals during study
- Standard daily multivitamin/mineral supplement (i.e., therapeutic doses of calcium and vitamin D for osteoporosis) allowed
- No concurrent lithium, phenytoin, or sulfonamides
- WBC >= 3,000/mm^3
- No history of bleeding or clotting disorder
- At least 3 months since prior and no concurrent coumadin or other systemic anticoagulant other than aspirin
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Arm I
Participants receive oral sulindac twice daily for 8 weeks
|
Korrelative undersøgelser
Gives oralt
Andre navne:
|
Placebo komparator: Arm II
Participants receive oral placebo twice daily for 8 weeks
|
Korrelative undersøgelser
Inactive agent
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Sulindac Concentration in the Nevi (Moles)
Tidsramme: 8 weeks
|
8 weeks
|
Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi
Tidsramme: 8 weeks
|
8 weeks
|
Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi
Tidsramme: 8 weeks
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Sulindac Effects on Apoptosis in Atypical Nevi
Tidsramme: Baseline and 8 weeks
|
Change in the expression of a marker of apoptosis, cleaved caspase 3, in melanocytic junctional component
|
Baseline and 8 weeks
|
Sulindac Effects on Vascular Endothelial Growth Factor (VEGF) Expression in Atypical Nevi
Tidsramme: Baseline and 8 weeks
|
Change in VEGF expression in melanocytic junctional component
|
Baseline and 8 weeks
|
Association Between Plasma and Target Tissue Sulindac Levels
Tidsramme: 8 weeks
|
8 weeks
|
|
Association Between Plasma and Target Tissue Sulindac Sulfone Levels
Tidsramme: 8 weeks
|
8 weeks
|
|
Association Between Plasma and Target Tissue Sulindac Sulfide Levels
Tidsramme: 8 weeks
|
8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neuroektodermale tumorer
- Neoplasmer, kimceller og embryonale
- Neoplasmer, nervevæv
- Neuroendokrine tumorer
- Nevi og melanomer
- Melanom
- Forstadier til kræft
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Agenter fra det perifere nervesystem
- Enzymhæmmere
- Analgetika
- Sensoriske systemagenter
- Anti-inflammatoriske midler, ikke-steroide
- Analgetika, ikke-narkotisk
- Anti-inflammatoriske midler
- Antirheumatiske midler
- Cyclooxygenase-hæmmere
- Antineoplastiske midler
- Sulindac
Andre undersøgelses-id-numre
- NCI-2009-01115 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA023074 (U.S. NIH-bevilling/kontrakt)
- N01CN35158 (U.S. NIH-bevilling/kontrakt)
- UARIZ-08-0841-04
- CDR0000633938
- 08-0841-04 (Anden identifikator: University of Arizona Health Sciences Center)
- UAZ05-2-10 (Anden identifikator: DCP)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med laboratoriebiomarkøranalyse
-
Liao Jian AnRekrutteringHoved- og halskræftTaiwan
-
Fondation LenvalTrukket tilbage
-
Progenity, Inc.AfsluttetDowns syndrom | Aneuploidi | DiGeorges syndrom | Turners syndrom | Klinefelters syndrom | Kromosom sletning | Edwards syndrom | Patau syndromForenede Stater
-
IRCCS Eugenio MedeaRekrutteringAutismespektrumforstyrrelse | Tidlig indsatsItalien
-
Oregon Health and Science University4DMedicalTilmelding efter invitationLungesygdomme | KOL | Luftvejssygdom | DyspnøForenede Stater
-
IRCCS Eugenio MedeaRekrutteringCerebral Parese | Erhvervet hjerneskadeItalien
-
Modarres HospitalAfsluttetKomplikationer | Billedstyret biopsi | Nyre GlomerulusIran, Islamisk Republik
-
Healthy.io Ltd.Afsluttet
-
Medwave Estudios LimitadaAsociación Chilena de SeguridadUkendtErhvervsmæssig eksponering | Muskuloskeletal sygdomChile
-
Alcon ResearchAfsluttet