Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

293

Participants

Timeline

Start Date

December 17, 2007

Primary Completion Date

September 27, 2017

Study Completion Date

April 30, 2026

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

Induction Chemotherapy

All patients will receive 4 identical cycles of induction chemotherapy including highdose (5 g/m2 or 2.5g/m2 for patients less than or equal to 31 days of age at enrollment) intravenous methotrexate and standard dose vincristine, cisplatin, and cyclophosphamide.

DRUG

Low-Risk Therapy

Induction will be followed by further conventional chemotherapy with carboplatin, cyclophosphamide, and etoposide. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).

DRUG

High-Risk Therapy

High risk patients will also receive vinblastine with each course of induction chemotherapy. Induction will be followed by either chemotherapy with targeted intravenous topotecan and cyclophosphamide or optional craniospinal irradiation (CSI). CSI will be offered only to patients who reach 3 years of age by the end of induction only. After consolidation, all patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).

DRUG

Intermediate-Risk Therapy

"Induction will be followed by consolidation focal radiotherapy (RT) to the tumor bed. Patients less than 12 months old upon completion of induction will receive low risk chemotherapy to delay RT until the age of 12 months. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).~Note: The option to receive focal proton beam irradiation was suspended 10/29/2015. Focal photon beam irradiation continues as part of the treatment plan."

Trial Locations (6)

4029

Lady Cilento Children's Hospital, Brisbane, Brisbane

38105

St. Jude Children's Research Hospital, Memphis

55102

Children's Hospitals and Clinics of Minnesota - St. Paul, Saint Paul

75390

University of Texas Southwestern Medical Center at Dallas, Dallas

92123

Rady Children's Hospital, San Diego

94304

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

All Listed Sponsors
collaborator

University of Florida

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

The Pew Charitable Trusts

OTHER

lead

St. Jude Children's Research Hospital

OTHER

NCT00602667 - Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma | Biotech Hunter | Biotech Hunter