- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00180791
High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood
September 17, 2007 updated by: Gustave Roussy, Cancer Campus, Grand Paris
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
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
71
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chantal Kalifa, MD
- Phone Number: 33 1 42 11 4166
- Email: kalifa@igr.fr
Study Contact Backup
- Name: Agnès Laplanche, MD
- Phone Number: 33 1 42 11 4127
- Email: laplanche@igr.fr
Study Locations
-
-
-
Villejuif, France, 94800
- Recruiting
- Institut Gustave Roussy
-
Contact:
- Chantal Kalifa, MD
- Phone Number: 33 1 42 11 4166
- Email: kalifa@igr.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Toxicity
|
Progression-free survival of children less than 5 years of age with metastatic medulloblastoma
|
Long term sequelae
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chantal Kalifa, MD, Gustave Roussy, Cancer Campus, Grand Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
September 18, 2007
Last Update Submitted That Met QC Criteria
September 17, 2007
Last Verified
September 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms
- Brain Neoplasms
- Medulloblastoma
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Carboplatin
- Etoposide
- Melphalan
- Thiotepa
Other Study ID Numbers
- PNET HR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuroectodermal Tumors, Primitive
-
Gustave Roussy, Cancer Campus, Grand ParisCompletedMetastatic, Cerebral Primitive Neuroectodermal TumorsFrance
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Childhood Medulloblastoma | Untreated Childhood Supratentorial Primitive Neuroectodermal TumorUnited States
-
Mayo ClinicCompletedEwing Sarcoma of Bone | Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) | Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor and other conditionsUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)Active, not recruitingMedulloblastoma | Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor | Anaplastic Medulloblastoma | Supratentorial Embryonal Tumor, Not Otherwise SpecifiedUnited States, Canada, Australia, Puerto Rico
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedEwing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET)United States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedLocalized Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)WithdrawnEwing Sarcoma of Bone | Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor | Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) and other conditionsUnited States
-
Burzynski Research InstituteTerminatedPrimitive Neuroectodermal TumorUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor | Askin TumorUnited States, Canada, Puerto Rico, Australia, New Zealand, Switzerland
-
Burzynski Research InstituteCompletedChildhood CNS Primitive Neuroectodermal TumorUnited States
Clinical Trials on Etoposide, carboplatin, melphalan, cisplatin, thiotepa
-
University Hospital, BonnCompletedEpendymomas | Recurrent Brain Tumors | Supratentorial PNETs | MedulloblastomasGermany
-
BeiGeneActive, not recruiting
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedNeuroblastomaUnited States, Australia
-
Roswell Park Cancer InstituteCompletedLymphoma | Unspecified Childhood Solid Tumor, Protocol Specific | Myelodysplastic Syndromes | Leukemia | Chronic Myeloproliferative Disorders | Unspecified Adult Solid Tumor, Protocol Specific | Myelodysplastic/Myeloproliferative Diseases | Nonmalignant NeoplasmUnited States
-
Roswell Park Cancer InstituteCompletedLymphoma | Unspecified Childhood Solid Tumor, Protocol Specific | Leukemia | Testicular Germ Cell Tumor | Breast Cancer | Unspecified Adult Solid Tumor, Protocol Specific | Multiple Myeloma and Plasma Cell NeoplasmUnited States
-
Parth PatelChildren's of AlabamaActive, not recruitingMedulloblastoma | Central Nervous System Embryonal TumorsUnited States, New Zealand, Canada
-
Gustave Roussy, Cancer Campus, Grand ParisCompletedMetastatic, Cerebral Primitive Neuroectodermal TumorsFrance
-
Children's Cancer and Leukaemia GroupCompleted
-
PfizerTerminatedSmall Cell Lung CarcinomaUnited States, Spain, Canada, Hungary
-
University Hospital MuensterHannover Medical School; Deutsche Kinderkrebsstiftung; Gesellschaft fur Padiatrische...UnknownIntracranial Germ Cell TumorsGermany