High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood

Phase 2

• Conditions: Medulloblastoma; Brain Tumors; Neuroectodermal Tumors, Primitive

• Registration Number: NCT00180791
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

The purpose of this study is to evaluate the efficacy of the combination of surgery, conventional chemotherapy, sequential high-dose chemotherapy with peripheral blood stem cell transplantation and reduced dose radiation therapy in high-risk PNET brain tumors.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-16
• Status Verified: 2006-09
• Last Update Submitted: 2007-09-17
• Last Update Posted: 2007-09-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• Medulloblastoma in patients less than 5 years of age
• Brain PNET in patients less than 10 years of age
• Histologically documented diagnosis
• Body weight of > 8 kg

Exclusion Criteria

• Parents' refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response of medulloblastoma metastases to the chemotherapy regimen in children less than 5 years of age
Progression-free survival of children less than 10 years of age with brain PNET

Secondary Outcome Measures

Name	Time	Method
Progression-free survival of children less than 5 years of age with metastatic medulloblastoma
Toxicity
Long term sequelae

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France