NCT00053118

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with peripheral stem cell transplantation in treating children who have central nervous system cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2002

Typical duration for phase_1

Geographic Reach
1 country

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

March 1, 2002

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

March 1, 2011

Status Verified

February 1, 2011

Enrollment Period

2.3 years

First QC Date

January 27, 2003

Last Update Submit

February 25, 2011

Conditions

Brain and Central Nervous System TumorsLymphomaNeuroblastomaRetinoblastoma

Keywords

childhood central nervous system germ cell tumorchildhood choroid plexus tumorchildhood craniopharyngiomachildhood grade I meningiomachildhood grade II meningiomachildhood grade III meningiomarecurrent childhood brain stem gliomarecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomarecurrent childhood ependymomarecurrent childhood medulloblastomarecurrent childhood supratentorial primitive neuroectodermal tumorrecurrent neuroblastomarecurrent retinoblastomachildhood visual pathway and hypothalamic gliomachildhood atypical teratoid/rhabdoid tumorprimary central nervous system non-Hodgkin lymphoma

Interventions

filgrastimBIOLOGICAL

IV

carboplatinDRUG

IV

etoposideDRUG

IV

bone marrow ablation with stem cell supportPROCEDURE

IV

peripheral blood stem cell transplantationPROCEDURE

IV

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed primary central nervous system malignancy * Recurrent, persistent, or progressive disease after at least 1 prior first-line treatment regimen PATIENT CHARACTERISTICS: Age * 18 and under at initial diagnosis Performance status * ECOG 0-2 Life expectancy * At least 8 weeks Hematopoietic * Absolute neutrophil count greater than 750/mm\^3 * WBC greater than 2,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * No underlying myelodysplasia, stem cell disorder, or other inherent hematologic synthetic defect Hepatic * Liver function tests less than 2 times normal OR * Absence of active hepatitis by liver biopsy * Bilirubin less than 1.5 mg/dL Renal * Glomerular filtration rate greater than 60 mL/min by radionucleotide assay Cardiovascular * Ejection fraction at least 45% Pulmonary * Clinically normal pulmonary function (patients 5 years of age and under) * FEV\_1 and FVC at least 50% (patients over 5 years of age) OR * Arterial blood gas normal and DLCO greater than 50% Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No mucositis or mucosal infection * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 3 weeks since prior systemic cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * At least 6 months since prior radiotherapy to the pelvis or spine Surgery * Not specified

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

Sponsors & Collaborators

Study Sites (3)

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsLymphomaNeuroblastomaRetinoblastomaChoroid Plexus NeoplasmsAstrocytomaFamilial ependymomaMedulloblastomaOptic Nerve GliomaRhabdoid Tumor

Interventions

FilgrastimCarboplatinEtoposidePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsEye Diseases, HereditaryEye DiseasesRetinal DiseasesCerebral Ventricle NeoplasmsBrain NeoplasmsBrain DiseasesCentral Nervous System DiseasesGliomaOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesNeoplasms, Complex and Mixed

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Barbara Jean Bambach, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2003

First Posted

January 28, 2003

Study Start

March 1, 2002

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

March 1, 2011

Record last verified: 2011-02

Locations

US(3)