Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

Summary

This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.

Conditions

• Anaplastic Medulloblastoma
• Medulloblastoma
• Supratentorial Embryonal Tumor, Not Otherwise Specified
• Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous PBSC resuce

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Etoposide

Given IV

BIOLOGICAL

Filgrastim

Given IV or SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leucovorin Calcium

Given IV or orally

DRUG

Methotrexate

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

DRUG

Thiotepa

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Claire M Mazewski · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-10-22

Primary Completion

2016-12-31

Completion

2025-09-30

Countries

• United States
• Australia
• Canada
• Puerto Rico

Study Locations