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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
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris Identifier:
First received: September 9, 2005
Last updated: September 17, 2007
Last verified: September 2006
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
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: 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

Ages Eligible for Study:   up to 10 Years   (Child)
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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00180791

Contact: Chantal Kalifa, MD 33 1 42 11 4166
Contact: Agnès Laplanche, MD 33 1 42 11 4127

Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Chantal Kalifa, MD    33 1 42 11 4166   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Chantal Kalifa, MD Gustave Roussy, Cancer Campus, Grand Paris
  More Information Identifier: NCT00180791     History of Changes
Other Study ID Numbers: PNET HR
Study First Received: September 9, 2005
Last Updated: September 17, 2007

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

Additional relevant MeSH terms:
Brain Neoplasms
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists processed this record on May 25, 2017