- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Arizona
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Tucson, Arizona, Estados Unidos, 85724
- University of Arizona Health Sciences Center
-
-
California
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Stanford, California, Estados Unidos, 94305
- Stanford University Hospitals and Clinics
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Arm I
Participants receive oral sulindac twice daily for 8 weeks
|
Estudios correlativos
Administrado oralmente
Otros nombres:
|
Comparador de placebos: Arm II
Participants receive oral placebo twice daily for 8 weeks
|
Estudios correlativos
Inactive agent
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Sulindac Concentration in the Nevi (Moles)
Periodo de tiempo: 8 weeks
|
8 weeks
|
Sulindac Sulfone, an Active Metabolite of Sulindac, Concentration in the Nevi
Periodo de tiempo: 8 weeks
|
8 weeks
|
Sulindac Sulfide, an Active Metabolite of Sulindac, Concentration in the Nevi
Periodo de tiempo: 8 weeks
|
8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sulindac Effects on Apoptosis in Atypical Nevi
Periodo de tiempo: 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
Periodo de tiempo: Baseline and 8 weeks
|
Change in VEGF expression in melanocytic junctional component
|
Baseline and 8 weeks
|
Association Between Plasma and Target Tissue Sulindac Levels
Periodo de tiempo: 8 weeks
|
8 weeks
|
|
Association Between Plasma and Target Tissue Sulindac Sulfone Levels
Periodo de tiempo: 8 weeks
|
8 weeks
|
|
Association Between Plasma and Target Tissue Sulindac Sulfide Levels
Periodo de tiempo: 8 weeks
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Tumores neuroendocrinos
- Nevos y Melanomas
- Melanoma
- Condiciones precancerosas
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes del sistema nervioso periférico
- Inhibidores de enzimas
- Analgésicos
- Agentes del sistema sensorial
- Agentes antiinflamatorios no esteroideos
- Analgésicos no narcóticos
- Agentes antiinflamatorios
- Agentes antirreumáticos
- Inhibidores de la ciclooxigenasa
- Agentes antineoplásicos
- Sulindac
Otros números de identificación del estudio
- NCI-2009-01115 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- P30CA023074 (Subvención/contrato del NIH de EE. UU.)
- N01CN35158 (Subvención/contrato del NIH de EE. UU.)
- UARIZ-08-0841-04
- CDR0000633938
- 08-0841-04 (Otro identificador: University of Arizona Health Sciences Center)
- UAZ05-2-10 (Otro identificador: DCP)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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