NCT00006258

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients who have surgically resected, newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1997

Longer than P75 for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1997

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

July 18, 2013

Status Verified

December 1, 2004

First QC Date

September 11, 2000

Last Update Submit

July 17, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood infratentorial ependymomachildhood supratentorial ependymomaadult medulloblastomaadult myxopapillary ependymomaadult anaplastic ependymomaadult ependymoblastomauntreated childhood supratentorial primitive neuroectodermal tumoruntreated childhood medulloblastomanewly diagnosed childhood ependymomaadult supratentorial primitive neuroectodermal tumor (PNET)

Interventions

filgrastimBIOLOGICAL
cisplatinDRUG
cyclophosphamideDRUG
etoposideDRUG
methotrexateDRUG
vincristine sulfateDRUG
adjuvant therapyPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histological confirmation of one of the following: * High stage medulloblastoma with neuraxis dissemination (Chang stage M1 or greater) * Primitive neuroectodermal tumor * Ependymoma * Incompletely resected on postoperative MRI or neurosurgical report * Definitive prior surgery within 42 days of study PATIENT CHARACTERISTICS: Age: * 10 to 65 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 1.5 mg/dL * SGPT less than 2.5 times upper limit of normal Renal: * Creatinine clearance greater than 60 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Prior corticosteroids allowed * No concurrent corticosteroids as antiemetics Radiotherapy: * No prior radiotherapy Surgery: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-1320, United States

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Related Publications (1)

  • Dhodapkar K, Dunkel IJ, Gardner S, Sapp M, Thoron L, Finlay J. Preliminary results of dose intensive pre-irradiation chemotherapy in patients older than 10 years of age with high risk medulloblastoma and supratentorial primitive neuroectodermal tumors. Med Pediatr Oncol. 2002 Jan;38(1):47-8. doi: 10.1002/mpo.1262. No abstract available.

    PMID: 11835236RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsMedulloblastomaEpendymomaNeuroectodermal Tumors, Primitive

Interventions

FilgrastimCisplatinCyclophosphamideEtoposideMethotrexateVincristineChemotherapy, AdjuvantRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesIndolizidinesIndolizinesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Jonathan L. Finlay, MB, ChB

    Children's Hospital Los Angeles

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

November 1, 1997

Study Completion

January 1, 2005

Last Updated

July 18, 2013

Record last verified: 2004-12

Locations

US(2)CA(1)