NCT00180791

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 18, 2007

Status Verified

September 1, 2006

First QC Date

September 9, 2005

Last Update Submit

September 17, 2007

Conditions

MedulloblastomaBrain TumorsNeuroectodermal Tumors, Primitive

Keywords

Brain PNET

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • Progression-free survival of children less than 5 years of age with metastatic medulloblastoma

  • Toxicity

  • Long term sequelae

Interventions

Etoposide, carboplatin, melphalan, cisplatin, thiotepaDRUG

Eligibility Criteria

AgeUp to 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Parents' refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

MedulloblastomaBrain NeoplasmsNeuroectodermal Tumors, Primitive

Interventions

EtoposideCarboplatinMelphalanCisplatinThiotepa

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCoordination ComplexesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramidesOrganophosphorus CompoundsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Chantal Kalifa, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Kalifa, MD

CONTACT

33 1 42 11 4166kalifa@igr.fr

Agnès Laplanche, MD

CONTACT

33 1 42 11 4127laplanche@igr.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

July 1, 2002

Last Updated

September 18, 2007

Record last verified: 2006-09

Locations

FR(1)