High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris (Other)
Overall Status
Unknown status
CT.gov ID
NCT00180791
Collaborator
(none)
71
1
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
71 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Jul 1, 2002
Outcome Measures
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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Institut Gustave Roussy | Villejuif | France | 94800 |
Sponsors and Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
Investigators
- Principal Investigator: Chantal Kalifa, MD, Gustave Roussy, Cancer Campus, Grand Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00180791
Other Study ID Numbers:
- PNET HR
First Posted:
Sep 16, 2005
Last Update Posted:
Sep 18, 2007
Last Verified:
Sep 1, 2006
Keywords provided by ,
,
Additional relevant MeSH terms: