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PNOC027Genomic Testing for Personalized Treatment in Relapsed Medulloblastoma and Ependymoma

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Objetivo del estudio

This study aims to determine how genomic testing can guide personalized treatment plans for children and young adults with relapsed medulloblastoma and ependymoma, focusing on improving progression-free survival and ensuring timely treatment recommendations.

Qué se está evaluando

Specialized Tumor Board Treatment Plan

+ Combinations

Otro
Quiénes están siendo reclutados

Ependimoma+5

+ Glioma

+ Meduloblastoma

De 12 meses a 39 años
+20 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Otro tipo de estudio

Intervencional
Inicio del estudio: febrero de 2022
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of California, San Francisco
Contacto del EstudioPNOC Operation Office
Última actualización: 17 de marzo de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 22 de febrero de 2022

Fecha en la que se inscribió al primer participante.

This study is focused on creating personalized treatment plans for children and young adults who have experienced a relapse of two types of brain tumors: medulloblastoma and ependymoma. By using advanced techniques like drug screening and genetic testing, researchers aim to tailor a treatment plan that uses up to four existing FDA-approved drugs for each participant. The main goal is to see if these personalized plans can improve survival rates and safety compared to traditional treatments. This approach is important as it could lead to more effective and less harmful treatments for these patients, offering hope for better management of their conditions. Participants in the study will have tissue samples taken from their tumors, which are then analyzed using drug screening and genetic sequencing. Based on this analysis, a specialized team recommends a treatment plan tailored to the individual. Participants may continue this treatment for up to two years, or longer if it is beneficial. The study measures how long participants live without their disease progressing, as well as their overall survival. Safety and potential side effects are also closely monitored to ensure treatments are well-tolerated. The results could lead to more precise and effective therapies for relapsed brain tumors in young patients.

Título OficialA Pilot Feasibility and Efficacy (Phase 2) Trial of Real Time Drug Screening and Genomic Testing to Determine an Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma and Ependymoma
NCT05057702
Patrocinador PrincipalUniversity of California, San Francisco
Contacto del EstudioPNOC Operation Office
Última actualización: 17 de marzo 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 74 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Otro Tipo de Estudio

Algunos estudios exploran temas que no encajan en una categoría específica. Pueden incluir investigaciones innovadoras, nuevas tecnologías o áreas emergentes en el ámbito de la salud.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 12 meses a 39 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

EpendimomaGliomaMeduloblastomaNeoplasiasNeoplasias de Células Germinales y EmbrionariasNeoplasias por tipo histológicoNeoplasias glandulares y epitelialesNeoplasias del Tejido Nervioso

Criterios

13 criterios de inclusión requeridos para participar
Participants must have recurrent medulloblastoma or recurrent ependymoma previously histologically confirmed. Participants must be experiencing their first or second relapse to be eligible.

Participants must have surgically accessible disease.

Prior Therapy: 1. The participant must have received at least one prior therapy at the time of initial diagnosis. 2. Relapsed medulloblastoma or relapsed ependymoma are eligible. 3. Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and would be eligible for surgical resection per institutional guidelines * Participants must have received last chemotherapy or biologic agent at least 7 days prior to registration. * Monoclonal antibody treatment: \> 21 days prior to registration. * Bevacizumab participants must have received last dose \> 21 days prior to study registration

Participant must be a candidate for surgical resection or biopsy with anticipated ability to obtain the minimum tissue requirements for study.

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7 criterios de exclusión impiden participar
Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Participants who are receiving any other investigational agents.

Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur. Such participants should also be discussed with study chairs.

Participants who are currently taking any anti-cancer direct therapy. Steroids are not considered anti-cancer therapy.

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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
Participants will receive an individualized treatment recommendation including a combination of up to four FDA-approved drugs within 21 business days of tissue acquisition using the results of real-time high-throughput drug screening, whole exome sequencing (WES), and RNA sequencing.

Grupo II

Experimental
Participants will receive an individualized treatment recommendation including a combination of up to four FDA-approved drugs within 21 business days of tissue acquisition using the results of real-time high-throughput drug screening, whole exome sequencing (WES), and RNA sequencing.

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

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 8 ubicaciones

Reclutando

St. Louis Children's Hospital / Washington University in St. Louis

St Louis, United StatesAbrir St. Louis Children's Hospital / Washington University in St. Louis en Google Maps
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New York University

New York, United States
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Columbia University Medical Center

New York, United States
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Children's Hospital of Philadelphia

Philadelphia, United States
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8 Centros de Estudio