Molecular and Clinical Risk-Directed Therapy for Infants and Young Children With Newly Diagnosed Medulloblastoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

December 20, 2022

Primary Completion Date

July 31, 2035

Study Completion Date

July 31, 2035

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.

Trial Locations (10)

32806

RECRUITING

Orlando Health Arnold Palmer Hospital for Children, Orlando

33607

RECRUITING

St. Joseph's Children's Hospital, Tampa

38105

RECRUITING

St. Jude Children's Research Hospital, Memphis

48109

RECRUITING

C.S. MOTT Children's Hospital, University of Michigan, Ann Arbor

55404

RECRUITING

Children's Hospital and Clinics of Minnesota, Minneapolis

75235

RECRUITING

UT Southwestern/Simmons Cancer Center, Dallas

76104

RECRUITING

Cook Children's Medical Center, Fort Worth

77477

RECRUITING

Texas Children's Hospital, Houston

84113

RECRUITING

Primary Children's Hospital, Salt Lake City

94304

RECRUITING

Lucille Packard Children's Hospital at Stanford University, Palo Alto

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

St. Jude Children's Research Hospital

OTHER