A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma
filgrastim
+ cisplatin
+ cyclophosphamide
Glioma+8
+ Neoplasias
+ Neoplasias por tipo histológico
Estudio de Tratamiento
Resumen
Fecha de inicio: 4 de mayo de 1999
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy. Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation. Determine the toxic effects associated with this treatment in these patients. OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years. PROJECTED ACCRUAL: A total of 33 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 33 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.De 18 a 120 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 central nervous system cancer including: Medulloblastoma with either local residual disease of greater than 1 cm^2 on MRI following resection or evidence of metastases (M1-4) Other primitive neuroectodermal tumors Ependymoma with evidence of subarachnoid metastases Must have less than 1 cm of midline shift or no acute elevated intercranial pressure PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm^3 Platelet count greater than 125,000/mm^3 Hemoglobin greater than 10 g/dL No preexisting hematologic condition that would increase toxicity or limit ability to comply with evaluations and follow-up Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT less than 2 times ULN Alkaline phosphatase less than 2 times ULN No preexisting hepatic condition that would increase toxicity or limit ability to comply with evaluations and follow-up Renal: Creatinine greater than 70 mL/min No preexisting renal condition that would increase toxicity or limit ability to comply with evaluations and follow-up Pulmonary: No history of significant pulmonary disease or, if there is preexisting pulmonary disease, then DLCO greater than 60% of predicted No preexisting pulmonary condition that would increase toxicity or limit ability to comply with evaluations and follow-up Other: No preexisting psychiatric condition that would increase toxicity or limit ability to comply with evaluations and follow-up No prior or concurrent malignancies within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No increasing doses of steroids for intracranial disease within 3 days of registration Radiotherapy: No prior radiotherapy Surgery: 10-28 days since prior surgical resection OR At least 5 days since prior biopsy
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 14 ubicaciones
H. Lee Moffitt Cancer Center and Research Institute
Tampa, United StatesAbrir H. Lee Moffitt Cancer Center and Research Institute en Google MapsVeterans Affairs Medical Center - Lakeside Chicago
Chicago, United StatesRobert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesCCOP - Carle Cancer Center
Urbana, United States