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HeadStart4: Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors

Overview

Información sobre este estudio

The purpose of this study is to determine whether dose-intensive tandem Consolidation, in a randomized comparison with single cycle Consolidation, provides an event-free survival (EFS) and overall survival (OS). The study population will be high-risk patients (non-Wnt and non-Shh sub-groups) with medulloblastoma, and for all patients with central nervous system (CNS) embryonal tumors completing "Head Start 4" Induction. This study will further determine whether the additional labor intensity (duration of hospitalizations and short-term and long-term morbidities) associated with the tandem treatment is justified by the improvement in outcome. It is expected that the tandem (3 cycles) Consolidation regimen will produce a superior outcome compared to the single cycle Consolidation, given the substantially higher dose intensity of the tandem regimen, without significant addition of either short-term or long-term morbidities.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Children ≥ 10 years old at the time of definitive confirmatory eligibile histologic or cytological diagnosis of eligible CNS tumor within the brain or spinal cord.
  • Children who have not previously received either irridation or chemotherapy (except corticosteriods).  

CNS Embryonal Tumors:

  • All children less than 120 months (10 years) of age, irrespective of clinical stage, with a diagnosis of any of the following CNS embryonal tumors are eligible, whether located primarily in the brain or spinal cord: pineoblastoma, pineal anlage tumor, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS embryonal tumor, not otherwise specified.

Exclusion Criteria:

  • Children < 10 years of age.
  • The exclusive focus is on medulloblastoma and other CNS embryonal tumors of the brain or spinal cord as follows:

Medulloblastoma:

  • Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis.
  • Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis.
  • Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection.

Eligibility last updated 1/6/22. Questions regarding updates should be directed to the study team contact.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Jonathan Schwartz, D.O., M.P.H.

Cerrado; inscripción por invitación

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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

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Otros temas en investigación

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CLS-20533479

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