Quimioterapia con Cisplatino y Etopósido para Malignidades de Células Germinales del Sistema Nervioso Central
Este estudio de fase 2 tiene como objetivo evaluar la tasa de respuesta, la supervivencia y la función endocrina y cognitiva en individuos que están recibiendo tratamiento de quimioterapia con Cisplatino y Etopósido para malignidades de células germinales del Sistema Nervioso Central.
cisplatin
+ etoposide
+ conventional surgery
Neoplasias+4
+ Neoplasias por tipo histológico
+ Neoplasias por Sitio
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1991
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the response rate of patients with newly diagnosed CNS germ cell tumors treated with cisplatin and etoposide. Determine the survival of patients with CNS germ cell tumors treated with cisplatin and etoposide followed by cranial radiotherapy. Determine endocrine and cognitive function in these patients before and after receiving this regimen. OUTLINE: Patients are stratified by histology (germinoma vs nongerminoma). Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of 4 courses, patients with nongerminoma who achieve complete response (CR) and all patients with germinoma proceed to radiotherapy. After completion of 4 courses, patients with nongerminoma who achieve less than CR undergo resection of any residual cranial masses, if feasible, and then proceed to radiotherapy. Patients who experience disease progression or unacceptable toxicity during chemotherapy are restaged and proceed directly to radiotherapy. Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after recovering from any toxic effects of chemotherapy, eligible patients undergo a regimen of craniospinal axis irradiation and/or localized cranial or spinal field irradiation based on histology, extent of disease, and response to chemotherapy. Patients with gross spinal meningeal disease after completion of chemotherapy undergo radiotherapy boost. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A total of 12-25 patients with germinoma will be accrued for this study within 3-6 years. A total of 12-25 patients with nongerminoma will be accrued for this study within 6-12 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 proven CNS germ cell tumor of 1 of the following subtypes: CNS germinoma Immature teratoma Embryonal cell carcinoma Yolk sac tumor Endodermal sinus tumor Choriocarcinoma OR Pineal or suprasellar mass associated with elevated CSF alpha fetoprotein or beta-human chorionic gonadotropin allowed Patients 18 years and over with localized pure germinomas ineligible Evaluable CT or MRI of brain and/or spinal cord required PATIENT CHARACTERISTICS: Age: 3 and over Hematopoietic: Age 18 and over: WBC at least 4,000/mm^3 Platelet count at least 100,000/mm^3 Under age 18: Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Creatinine no greater than 0.3 mg/dL above upper limit of normal for age Other: No uncontrolled infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for CNS germ cell tumor Endocrine therapy: Concurrent corticosteroids allowed except as antiemetics Radiotherapy: No prior cranial or spinal radiotherapy Surgery: Not specified
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 3 ubicaciones
Mayo Clinic - Jacksonville
Jacksonville, United StatesMayo Clinic Cancer Center
Rochester, United States