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

  1. Response of medulloblastoma metastases to the chemotherapy regimen in children less than 5 years of age []

  2. Progression-free survival of children less than 10 years of age with brain PNET []

Secondary Outcome Measures

  1. Progression-free survival of children less than 5 years of age with metastatic medulloblastoma []

  2. Toxicity []

  3. 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

Study Results

No Results Posted as of Sep 18, 2007