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Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

filgrastim

+ cisplatin
+ cyclophosphamide
Biológico
Medicamento
Procedimiento
Radiación
Quiénes están siendo reclutados

Glioma
+7

+ Meduloblastoma
+ Neoplasias
De 3 a 21 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 3
Intervencional
Inicio del estudio: agosto de 2003
Ver detalles del protocolo

Resumen

Patrocinador PrincipalSt. Jude Children's Research Hospital
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 1 de agosto de 2003Fecha en la que se inscribió al primer participante.

SECONDARY OBJECTIVES: * To compare the effects of a computer-based training system specifically targeting language, reading, and learning skills (Fast ForWord, Scientific Learning Corporation) with the current standard of care on reading decoding skills as measured by individual academic testing. * To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation. * To correlate radiation dosimetry of target and normal tissues with rate and patterns of failure and longitudinal measures of audiometric, endocrine and cognitive effects. EXPLORATORY OBJECTIVES: * To estimate the change in neuropsychological performance from the neuropsychology assessment battery (intellect, academic achievement and cognitive ability) and examine the relationship of these changes to risk group, age at diagnosis, and parent measures. * To evaluate the differences between neurotoxicity in the average-risk patient group with that in the high-risk group through qMRI, and fMRI. * To develop or refine novel models relating impact of medulloblastoma therapy on neurocognitive performance to quantitative and functional neuroimaging measures. OUTLINE: This is a multicenter study. Patients are stratified according to disease risk (high-risk disease vs average-risk disease). Patients in both strata undergo peripheral blood stem cell or bone marrow harvest. * Stratum 1 (high-risk group): * Radiotherapy: Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. * High-dose chemotherapy and autologous stem cell transplantation (SCT): Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy comprising vincristine IV followed by cisplatin IV over 6 hours on day -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo autologous SCT on day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover. Patients receive vincristine IV on day 6. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity. * Stratum 2 (average-risk group): * Radiotherapy: Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose. * High-dose chemotherapy and autologous SCT: Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1. Some patients undergo a neuropsychology assessment at baseline, before chemotherapy, and then annually for 5 years. After completion of study therapy, patients are followed every 3 months until month 30 (2.5 years) after diagnosis and then every 6 months until month 72 (6 years) after diagnosis.

Título OficialTreatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor 
NCT00085202
Patrocinador PrincipalSt. Jude Children's Research Hospital
Última actualización: 14 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 416 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.
Estudio de Tratamiento
Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.

Cómo se asignan los participantes a diferentes grupos/brazos
En este estudio clínico, los participantes se asignan a los grupos según criterios específicos, como su historial médico o la recomendación de un médico. Este enfoque busca asegurar que los tratamientos se administren a quienes podrían beneficiarse más, según factores conocidos.

Otras formas de asignar participantes
Asignación aleatoria
: Los participantes se asignan al azar, como si se lanzara una moneda, para garantizar equidad y reducir sesgos.

Ninguna (ensayo de un solo brazo)
: Si el estudio tiene un solo grupo, todos los participantes reciben el mismo tratamiento y no se necesita asignación.

Cómo se administran los tratamientos a los participantes
Los participantes se dividen en diferentes grupos, y cada uno recibe un tratamiento específico al mismo tiempo. Esto ayuda a los investigadores a comparar la eficacia de los distintos tratamientos entre sí.

Otras formas de asignar tratamientos
Asignación a un solo grupo
: Todos reciben el mismo tratamiento.

Asignación cruzada
: Los participantes cambian de tratamiento durante el estudio.

Asignación factorial
: Los participantes reciben diferentes combinaciones de tratamientos.

Asignación secuencial
: Los participantes reciben tratamientos uno tras otro en un orden específico, posiblemente según su respuesta individual.

Otra asignación
: La asignación de tratamientos no sigue un diseño estándar o predefinido.

Cómo se controla la efectividad del tratamiento
En un estudio no controlado con placebo, ningún participante recibe una sustancia inerte (placebo) para comparar los resultados. En su lugar, todos los participantes reciben el tratamiento experimental o una alternativa activa (a menudo el tratamiento estándar). Este método permite comparar los efectos del tratamiento experimental con los de otra intervención activa, en lugar de un placebo.

Otras opciones
Controlado con placebo
: Se utiliza un placebo para comparar los efectos del tratamiento experimental con los de una sustancia inerte, aislando así el efecto real del tratamiento.

Cómo se mantiene la confidencialidad de las intervenciones asignadas a los participantes
Todos los involucrados en el estudio saben qué tratamiento se está administrando. Esto se utiliza cuando no es posible o necesario ocultar los detalles del tratamiento a los participantes o investigadores.

Otras formas de enmascarar la información
Simple ciego
: Los participantes no saben qué tratamiento están recibiendo, pero los investigadores sí.

Doble ciego
: Ni los participantes ni los investigadores saben qué tratamiento se está administrando.

Triple ciego
: Participantes, investigadores y evaluadores de resultados no saben qué tratamiento se está administrando.

Cuádruple ciego
: Participantes, investigadores, evaluadores de resultados y personal de atención no saben qué tratamiento se está administrando.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
De 3 a 21 añosRango de edades de los participantes que pueden unirse al estudio.
Voluntarios sanos no permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Glioma
Meduloblastoma
Neoplasias
Neoplasias de Células Germinales y Embrionarias
Neoplasias por Sitio
Neoplasias por tipo histológico
Neoplasias glandulares y epiteliales
Neoplasias del Tejido Nervioso
Enfermedades del sistema nervioso
Neoplasmas del Sistema Nervioso
Criterios

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Medulloblastoma * Supratentorial primitive neuroectodermal tumor (PNET) * PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma) * Atypical teratoid rhabdoid tumor (ATRT) * Definitive surgery for CNS tumor within the past 31 days * Meets one of the following risk criteria: * Average-risk disease * Localized disease with no overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET or ATRT) by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI * T4 disease eligible if all of the following are true: * Gross total resection determined by intraoperative observations of the neurosurgeon AND postoperative CT scan or MRI * Residual tumor or imaging abnormality whose size is \< 1.5 cm\^2 * No evidence of CNS or extraneural metastasis by MRI of the spine (with and without contrast agent) or CT-based myelogram AND by cytologic examination of the lumbar cerebral spinal fluid (CSF) 14-28 days after surgery * Brain stem invasion allowed in the absence of residual tumor (tumor \< 1.5 cm\^2 by imaging) * High-risk disease meeting one of the following criteria: * Metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination by imaging and/or cytologic examination of CSF) * Presence of residual disease \> 1.5 cm\^2 at the primary site after surgery PATIENT CHARACTERISTICS: Age * 3 to 21 at diagnosis Performance status * Lansky 30-100% (\< 10 years old) * Karnofsky 30-100% (≥ 10 years old) (except for posterior fossa syndrome) Life expectancy * Not specified Hematopoietic * Hemoglobin \> 8 g/dL * WBC \> 2,000/mm\^3 * Absolute neutrophil count \> 500/mm\^3 * Platelet count \> 50,000/mm\^3 Hepatic * ALT \< 5 times normal * Bilirubin \< 3.0 mg/dL Renal * Creatinine \< 2.0 mg/dL OR * Creatinine clearance \> 70 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Prior corticosteroid therapy allowed Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio
2 grupos de intervención 

están designados en este estudio

0% de probabilidad 

de ser asignado al grupo placebo

Grupos de Tratamiento
Grupo I
Experimental
Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks. Six weeks after the completion of radiotherapy, patients receive high-dose chemotherapy followed by autologous stem cell transplantation (SCT) and filgrastim (G-CSF) with post-transplantation vincristine. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional courses in the absence of unacceptable toxicity. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy

Given subcutaneously

Given IV

Given IV

Given IV

Patients undergo autologous stem cell transplantation

Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.
Grupo II
Experimental
Patients undergo craniospinal radiotherapy as in stratum 1, but at a lower dose. Patients receive high-dose chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in stratum 1. Interventions: vincristine, cisplatin, cyclophosphamide, autologous hematopoietic stem cell transplantation, filgrastim, radiation therapy

Given subcutaneously

Given IV

Given IV

Given IV

Patients undergo autologous stem cell transplantation

Patients undergo craniospinal radiotherapy once daily 5 days a week for 6 weeks.
Objetivos del Estudio
Objetivos Primarios

The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.

122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.

The frequency of mutations for the main genes associated with SHH and WNT tumors identified via targeted sequencing based on formalin fixed paraffin embedded material is provided.
Objetivos Secundarios

SOC is standard-of-Care control group. Patients randomly assigned to the control group received the current standard of care. RI is Reading Intervention Group. Patients randomly assigned to Reading Intervention Group which is with The Fast ForWord program. Assessment of reading decoding was completed using the Woodcock Johnson, Third Edition (WJIII) Tests of Achievement (Woodcock, McGraw, \& Mather, 2001), with particular attention given to the reading and reading-related abilities. Two subtests were completed: (1) Letter-Word Identification, and (2) Word Attack, a test requiring the patient to read phonologically regular nonwords. The combination of these two subtests provided a standardized composite score of overall reading decoding ability with a population mean of 100 and a standard deviation of 15. Scores of 90-110 are considered to be in the average range, while those 80-89 are considered low-average (refer: Journal of Pediatric Psychology 39(4) pp. 450-458, 2014).

To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.

Assessment of associative memory at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.

Assessment of associative memory at 5 years after enrollment. Assessment of associative memory score at enrollment. Associate memory score is a representative measurement of learning and recalling pictograph representations of words. It measures associative memory (Long-Term Retrieval). Mean=100, SD=15, Average Range 85-115. Higher is better.

Assessment of Processing Speed at enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.

Assessment of Processing Speed at 5 years after enrollment. This score measure of Processing Speed based on Visual Matching and Decision Speed tests. Mean=100, SD=15, Average Range 85-115. Higher is better.

Assessment of Perceptual Speed at enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.

Assessment of Perceptual Speed at 5 years after enrollment. It measures rapidly locating and circling identical numbers from a set of numbers which reflects perceptual speed. Mean=100, SD=15, Average Range 85-115. Higher is better.

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 9 ubicaciones
Suspendido
Duke Comprehensive Cancer CenterDurham, United StatesVer ubicación
Suspendido
Children's Hospital of PhiladelphiaPhiladelphia, United States
Suspendido
St. Jude Children's Research HospitalMemphis, United States
Suspendido
Texas Children's Cancer Center and Hematology Service at Texas Children's HospitalHouston, United States
Completado9 Centros de Estudio