Phase II Study of Recombinant Humanized Monoclonal Antibody Against HER2 for the Treatment of Recurrent Osteosarcoma
trastuzumab
+ conventional surgery
Neoplasias+2
+ Neoplasias por tipo histológico
+ Neoplasias del tejido conjuntivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the response rate, freedom from progression, and survival of patients with recurrent osteosarcoma when treated with trastuzumab (Herceptin). Evaluate the toxicity of this drug in young patients with a history of osteosarcoma and prior therapy with doxorubicin. OUTLINE: This is a multicenter study. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes weekly. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity. After approximately 12 weeks of treatment, patients are evaluated for response and undergo surgical resection if clinically appropriate. Patients are followed for 1 year for survival. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study within 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.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.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically confirmed recurrent osteosarcoma after initial systemic therapy with doxorubicin Measurable disease Immunohistochemical evidence of 2+ overexpression of HER2 PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: ALT or AST less than 3 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine less than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min Cardiovascular: Fractional shortening at least 29% by echocardiogram OR Ejection fraction at least 50% by MUGA No prior cardiac dysfunction, even if presently controlled Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy No prior anthracycline more than 450 mg/m^2 Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent cancer therapy
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 4 ubicaciones
City of Hope Comprehensive Cancer Center
Duarte, United StatesAbrir City of Hope Comprehensive Cancer Center en Google MapsDana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, United StatesMemorial Sloan-Kettering Cancer Center
New York, United StatesSt. Jude Children's Research Hospital
Memphis, United States