Back to resultsHigh Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood
Primary Purpose
Medulloblastoma, Brain Tumors, Neuroectodermal Tumors, Primitive
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Etoposide, carboplatin, melphalan, cisplatin, thiotepa
Sponsored by
About this trial
This is an interventional treatment trial for Medulloblastoma focused on measuring Brain PNET
Eligibility Criteria
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
Sites / Locations
- Institut Gustave RoussyRecruiting
Outcomes
Primary Outcome Measures
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
Progression-free survival of children less than 5 years of age with metastatic medulloblastoma
Toxicity
Long term sequelae
Full Information
NCT ID
NCT00180791
First Posted
September 9, 2005
Last Updated
September 17, 2007
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
1. Study Identification
Unique Protocol Identification Number
NCT00180791
Brief Title
High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medulloblastoma, Brain Tumors, Neuroectodermal Tumors, Primitive
Keywords
Brain PNET
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Etoposide, carboplatin, melphalan, cisplatin, thiotepa
Primary Outcome Measure Information:
Title
Response of medulloblastoma metastases to the chemotherapy regimen in children less than 5 years of age
Title
Progression-free survival of children less than 10 years of age with brain PNET
Secondary Outcome Measure Information:
Title
Progression-free survival of children less than 5 years of age with metastatic medulloblastoma
Title
Toxicity
Title
Long term sequelae
10. Eligibility
Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chantal Kalifa, MD
Phone
33 1 42 11 4166
Email
kalifa@igr.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Agnès Laplanche, MD
Phone
33 1 42 11 4127
Email
laplanche@igr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Kalifa, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantal Kalifa, MD
Phone
33 1 42 11 4166
Email
kalifa@igr.fr
12. IPD Sharing Statement
Learn more about this trial
High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood
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