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.

Conditions

• Medulloblastoma

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

Route of administration: Intravenously (IV)

DRUG

Carboplatin

Route of administration: Intravenously (IV)

DRUG

Topotecan

Route of administration: Intravenously (IV)

DRUG

Etoposide

Route of administration: Intravenously (IV)

DRUG

Pegfilgrastim

Route of administration: subcutaneous (SQ)

DRUG

Filgrastim

Route of administration: subcutaneous (SQ) or Intravenously (IV)

RADIATION

Irradiation

All participants in stratum N will undergo craniospinal irradiation (CSI) with boost to the primary tumor site once they reach 36 months of age. The dose given is based on the molecular risk group and disease response to chemotherapy as noted in the arm descriptions. The type of radiation used includes conformal radiation therapy (photons) or intensity modulated radiation therapy (IMRT) or proton beam therapy.

OTHER

Educational and Media Intervention

Participants watch a 75-minute caregiver education video program and receive access to interactive games on a smartphone or tablet throughout the optional cognitive study.

OTHER

SOC, Educational and Media Intervention

Standard-of-care (SOC) treatment during main cognitive study. After the one-year serial cognitive evaluation, participants will be offered participation in the cognitive study group I intervention.

DRUG

Methotrexate

Route of administration: Intravenously (IV) \& Intra Ventricular (IVT)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Giles W. Robinson, MD · St. Jude Children's Research Hospital

• Aditi Bagchi, MD, PhD · St. Jude Children's Research Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-20

Primary Completion

2035-07-31

Completion

2035-07-31

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations