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High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Institut Gustave Roussy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT00180791
First received: September 9, 2005
Last updated: September 17, 2007
Last verified: September 2006
History of Changes
  Purpose

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 Intervention Phase
Medulloblastoma
Brain Tumors
Neuroectodermal Tumors, Primitive
 Drug: Etoposide, carboplatin, melphalan, cisplatin, thiotepa
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

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

Estimated Enrollment: 71
Study Start Date: July 2002
  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180791

Contacts
Contact: Chantal Kalifa, MD 33 1 42 11 4166 kalifa@igr.fr
Contact: Agnès Laplanche, MD 33 1 42 11 4127 laplanche@igr.fr

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Chantal Kalifa, MD     33 1 42 11 4166     kalifa@igr.fr    
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Chantal Kalifa, MD Institut Gustave Roussy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00180791     History of Changes
Other Study ID Numbers: PNET HR
Study First Received: September 9, 2005
Last Updated: September 17, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Gustave Roussy:
Brain PNET

Additional relevant MeSH terms:
Brain Neoplasms
Medulloblastoma
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cisplatin
Etoposide
Melphalan
Thiotepa
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Myeloablative Agonists
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 16, 2013