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High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180791
First Posted: September 16, 2005
Last Update Posted: September 18, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
  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
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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Chantal Kalifa, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information

ClinicalTrials.gov Identifier: NCT00180791     History of Changes
Other Study ID Numbers: PNET HR
First Submitted: September 9, 2005
First Posted: September 16, 2005
Last Update Posted: September 18, 2007
Last Verified: September 2006

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Brain PNET

Additional relevant MeSH terms:
Neoplasms
Brain Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Medulloblastoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Glioma
Carboplatin
Etoposide
Melphalan
Thiotepa
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists