High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood

Brain Tumors Clinical Trial

Official title:

Treatment Protocol for High-Risk PNET Brain Tumors in Children With Surgery, Sequential Chemotherapy, Conventional and High-Dose With Peripheral Blood Stem Cell Transplantation and Radiation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00180791
• Other study ID #: PNET HR
• Status: Recruiting
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: September 17, 2007
• Start date: July 2002

Study information

• Verified date: September 2006
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Chantal Kalifa, MD
• Phone: 33 1 42 11 4166
• Email: kalifa[@]igr.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors
• Medulloblastoma
• Neoplasms
• Neuroectodermal Tumors
• Neuroectodermal Tumors, Primitive

Intervention

Drug:
• Etoposide, carboplatin, melphalan, cisplatin, thiotepa

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response of medulloblastoma metastases to the chemotherapy regimen in children less than 5 years of age
Primary	Progression-free survival of children less than 10 years of age with brain PNET
Secondary	Progression-free survival of children less than 5 years of age with metastatic medulloblastoma
Secondary	Toxicity
Secondary	Long term sequelae