A Phase II Trial of Isolated Limb Infusion With Melphalan and Dactinomycin for Regional Melanoma and Soft Tissue Sarcoma of the Extremity
dactinomycin
+ isolated limb perfusion
+ melphalan
Neoplasias+6
+ Neoplasias por tipo histológico
+ Neoplasias por Sitio
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de agosto de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the efficacy of isolated limb infusion (ILI) with melphalan and dactinomycin in patients with primary or recurrent, unresectable regional melanoma or soft tissue sarcoma of the extremity. Determine the morbidity of patients treated with this regimen. Determine the expression of melanoma-associated antigens as well as cellular and humoral immune responses to these antigens in patients with regional disease. OUTLINE: Patients undergo fluoroscopic placement of angiographic arterial and venous catheters into the appropriate extremity. After the limb is warmed, melphalan and dactinomycin are rapidly infused into the isolated limb via the arterial catheter. Melphalan and dactinomycin are then recirculated for 20 minutes. Patients with little or no response at 8 weeks may receive up to 2 additional treatments at the discretion of the treating physician. Patients are followed at 1-2 weeks, 3-4 weeks, 6-8 weeks, and then every 3-6 months thereafter as deemed necessary by the treating physician. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 3 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 35 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 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
Criterios
DISEASE CHARACTERISTICS: Histologically proven primary or recurrent, regional melanoma or soft tissue sarcoma that is not amenable to surgical resection Majority (greater than 95%) of disease must be distal to the apex of the femoral triangle in the lower limb and the deltoid insertion in the upper limb Bidimensionally measurable disease in the extremity Patients with disease beyond the limb are eligible if their extremity disease requires palliative treatment in the judgment of their physician PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: WBC at least 3,000/mm^3 Hepatic: Not specified Renal: Creatinine less than 2.0 mg/dL Cardiovascular: Must have palpable femoral/axillary, dorsalis pedis/popliteal, or radial pulses in the extremity to be treated No signs or symptoms of vascular insufficiency (no history of claudication or other ischemic peripheral vascular disease) Other: Not pregnant or nursing Negative pregnancy test No other concurrent serious illness No severe diabetes No prior extremity complications due to diabetes PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other At least 4 weeks since prior antitumor therapy and recovered At least 2 weeks since prior antibiotics
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Memorial Sloan-Kettering Cancer Center
New York, United StatesAbrir Memorial Sloan-Kettering Cancer Center en Google Maps