A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

June 23, 2013

Primary Completion Date

November 30, 2025

Study Completion Date

January 31, 2028

Conditions
Medulloblastoma
Interventions
RADIATION

Craniospinal Irradiation with boost to the primary tumor site

All participants will undergo craniospinal irradiation (CSI) with boost to the primary tumor site. The dose given is based on the molecular and risk group 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.

DRUG

Cyclophosphamide

Route of Administration (ROA): Intravenously (IV)

DRUG

Cisplatin

ROA: IV

DRUG

Vincristine

ROA: IV

DRUG

Vismodegib

ROA: Orally (PO)

DRUG

Pemetrexed

ROA: IV

DRUG

Gemcitabine

ROA: IV

OTHER

Aerobic Training

OTHER

Neurocognitive Remediation

Trial Locations (23)

1142

Starship Children's Hospital, Auckland

2031

Sydney Children's Hospital, Randwick

2145

Children's Hospital at Westmead, Westmead

3052

Royal Children's Hospital, Melbourne, Melbourne

4029

Queensland Children's Hospital, Brisbane

6008

Perth Children's Hospital, Perth

19104

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

27710

Duke Children's Hospital and Health Center, Durham

29425

Medical University of South Carolina, Charleston

32611

University of Florida, Gainesville

32806

Arnold Palmer Hospital for Children, Orlando

38105

St. Jude Children's Research Hospital, Memphis

55102

Children's Hospital and Clinics of Minnesota, Minneapolis

75390

University of Texas Southwestern Medical Center, Dallas

76104

Cook Children's Medical Center, Fort Worth

92123

Rady Children's Hospital, San Diego

94304

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

06520

Yale University, New Haven

77030-2399

Texas Children's Cancer Center, Houston

T3B 6A8

Alberta Children's Hospital, Calgary

M5G 1X8

The Hospital for Sick Children, Toronto

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

St. Jude Children's Research Hospital

OTHER