High Risk Primitive Neuroectodermal (PNET) Brain Tumors i... | NCT00180791

Studies
High Risk Primitive Neuroectodermal (PNET) Brain Tumors in Childhood

NCT00180791

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Unknown status

Last Update Posted

Sep 18, 2007Estimated

Enrollment

71Estimated

Phase

Phase 2

Conditions

Medulloblastoma
Brain Tumors
Neuroectodermal Tumors, Primitive

Interventions

Etoposide, carboplatin, melphalan, cisplatin, thiotepa

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2002

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2007

Last Update Posted Date

Sep 18, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Estimated

Name	Type	Description	Arm Group Labels	Other Names
Etoposide, carboplatin, melphalan, cisplatin, thiotepa	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Progression-free survival of children less than 5 years of age with metastatic medulloblastoma
Toxicity
Long term sequelae

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chantal Kalifa, MD	Contact	33 1 42 11 4166		kalifa@igr.fr
Agnès Laplanche, MD	Contact	33 1 42 11 4127		laplanche@igr.fr

Overall Officials

Name	Affiliation	Role
Chantal Kalifa, MD	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy	Recruiting	Villejuif		94800	France

Condition Browse Module

MeSH Terms

ID	Term
D008527	Medulloblastoma
D001932	Brain Neoplasms
D018242	Neuroectodermal Tumors, Primitive

Ancestor Terms

ID	Term
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005047	Etoposide
D016190	Carboplatin
D008558	Melphalan
D002945	Cisplatin
D013852	Thiotepa

Ancestor Terms

ID	Term
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided