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Treatment Of Patients With Metastatic Melanoma Using Nonmyeloablative But Lymphocyte Depleting Regimen Followed By The Administration Of In Vitro Sensitized Lymphocytes Reactive With ESO-1 Antigen

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Qué se está evaluando

Colección de datos

Quiénes están siendo reclutados

Melanoma+5

+ Neoplasias

+ Neoplasias de Células Germinales y Embrionarias

A partir de 16 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 2
Intervencional
Inicio del estudio: enero de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de enero de 2004

Fecha en la que se inscribió al primer participante.

OBJECTIVES: Primary * Determine the clinical tumor regression in patients with metastatic melanoma treated with a lymphocyte-depleting nonmyeloablative preparative chemotherapy regimen followed by autologous lymphocyte infusion, ESO-1 peptide vaccination comprising ESO-1:157-165 (165V) and Montanide ISA-51, and interleukin-2. Secondary * Determine the survival of the infused lymphocytes in patients treated with this regimen. * Determine the long-term immune status of patients treated with this regimen. OUTLINE: Patients are stratified according to type of lymphocyte infusion (ESO-1-reactive tumor-infiltrating lymphocytes \[TIL\] vs ESO-1 reactive peripheral blood lymphocytes \[PBL\]). * Autologous lymphocyte collection and expansion: Autologous PBL or TIL are collected from patients during leukapheresis or biopsy. The cells are sensitized in vitro with ESO-1:157-165 (165V) melanoma antigen and expanded. * Lymphocyte-depleting nonmyeloablative preparative chemotherapy: Patients receive lymphocyte-depleting nonmyeloablative preparative chemotherapy comprising cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 15-30 minutes on days -5 to -1. * Autologous lymphocyte infusion: Autologous PBL or TIL are reinfused on day 0\*. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 1 and continuing until blood counts recover. * ESO-1 peptide vaccination: Patients receive ESO-1 peptide vaccination comprising ESO-1:157-165 (165V) peptide emulsified in Montanide ISA-51 SC on days 0\*-4, 11, 18, and 25. * Interleukin therapy: Patients receive interleukin-2 IV over 15 minutes 3 times daily on days 0\*-4. NOTE: \*Day 0 is 1-4 days after the last dose of fludarabine. Patients achieving stable disease or partial response may receive up to 1 retreatment course. Patients with progressive disease after infusion of PBL may receive retreatment with TIL, if available. Patients are followed at 4-5 weeks, every 3-4 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 24-74 patients (12-37 per stratum) will be accrued for this study within 2-3 years.

Título OficialTreatment Of Patients With Metastatic Melanoma Using Nonmyeloablative But Lymphocyte Depleting Regimen Followed By The Administration Of In Vitro Sensitized Lymphocytes Reactive With ESO-1 Antigen
NCT00076661NCT00079144
Patrocinador PrincipalNational Cancer Institute (NCI)
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 16 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

MelanomaNeoplasiasNeoplasias de Células Germinales y EmbrionariasNeoplasias por SitioNeoplasias por tipo histológicoNeoplasias del Tejido NerviosoEnfermedades de la PielNeoplasias de la piel

Criterios

DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma that is refractory to standard therapy (including high-dose interleukin-2) * Measurable disease * HLA-A\*0201 positive * Epstein-Barr virus positive * ESO-1-expressing disease by reverse transcription polymerase chain reaction amplified tissue OR presence of ESO-1 serum antibody PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-1 Life expectancy * More than 3 months Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 8.0 g/dL Hepatic * Hepatitis B surface antigen negative * Hepatitis C antibody negative * AST and ALT \< 3 times upper limit of normal * Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL for patients with Gilbert's syndrome) * No coagulation disorders Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No prior myocardial infarction * No major cardiovascular illness by stress thallium or comparable test * No cardiac arrhythmias * LVEF ≥ 45% * Normal cardiac stress test required for the following conditions: * Prior EKG abnormalities * Symptoms of cardiac ischemia * Arrhythmias * Age 50 and over Pulmonary * FEV\_1 \> 60% of predicted (for patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction) * No obstructive or restrictive pulmonary disease * No other major respiratory illness Immunologic * HIV negative * No active systemic infection * No opportunistic infection * No major immune system illness * No form of primary or secondary immunodeficiency * No known hypersensitivity to study agents Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 4 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * Prior ESO-1-based vaccination allowed Chemotherapy * At least 6 weeks since prior nitrosoureas and recovered Endocrine therapy * No concurrent systemic steroid therapy Radiotherapy * Recovered from prior radiotherapy Surgery * Not specified Other * At least 4 weeks since prior systemic therapy

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Objetivos del Estudio

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

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Este estudio tiene 2 ubicaciones

Suspendido

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, United StatesAbrir Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support en Google Maps
Suspendido

NCI - Center for Cancer Research

Bethesda, United States
Completado2 Centros de Estudio