SJiMB21: Phase 2 Study of Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma

Summary

This is a multi-center, multinational phase 2 trial that aims to explore the use of molecular and clinical risk-directed therapy in treatment of children 0-4.99 years of age with newly diagnosed medulloblastoma.

Description

Eligibility

Age range

Up to 4 years

Sex

All

Healthy volunteers

No

Interventions

• Procedure
  Surgical resection

  All participants enrolled will undergo surgical resection prior to treatment. The maximal resection that can be achieved without undue risk to the patient will be attempted, with decisions about feasibility and extent of resection left to the discretion of the neurosurgeon. In instances where an STR is the best extent of resection achieved prior to start of therapy, a "second-look" surgery may be performed between cycles of chemotherapy after discussion with the principal investigator.

• Procedure
  Ommaya/VPS

  All participants enrolled on S-1 will undergo

• Drug
  Methotrexate

  Route of administration: Intravenously (IV)

• Drug
  Cisplatin

  Route of administration: Intravenously (IV)

• Drug
  Vincristine

  Route of administration: Intravenously (IV)

• Drug
  Cyclophosphamide

Locations (10)