Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
iodine I 131 monoclonal antibody 3F8
Enfermedades del Cerebro+40
+ Neoplasias bronquiales
+ Carcinoma broncogénico
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de abril de 1997
Fecha en la que se inscribió al primer participante.OBJECTIVES: Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms. Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors. Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in these patients. OUTLINE: This is a dose escalation study. Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection. Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD). Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study over 2-3 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.A partir de 3 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 confirmed malignancy expressing GD2, including, but not limited to: Medulloblastoma/primitive neuroectodermal tumor of the CNS Malignant glioma Neuroblastoma Retinoblastoma Ependymoma Sarcoma Melanoma Small cell lung carcinoma Other tumor types must have GD2 expression confirmed by immunohistochemical staining Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists Prior measurable human anti-mouse monoclonal antibody titer allowed PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Not specified Life expectancy: At least 2 months Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Platelet count greater than 50,000/mm^3 Hepatic: Bilirubin less than 3 mg/dL Renal: Creatinine less than 2 mg/dL Blood urea nitrogen less than 30 mg/dL Other: May have active malignancy outside the central nervous system No obstructive hydrocephalus No CNS grade 3 or 4 toxicity as a consequence of prior treatments No life threatening infection PRIOR CONCURRENT THERAPY: Biologic therapy: Prior monoclonal antibody treatment allowed Chemotherapy: Prior chemotherapy allowed Must have recovered from all hematopoietic and neurologic side effects of prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed At least 6 weeks since prior cranial or spinal irradiation Surgery: Not specified
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