NCT00025324

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, surgery, radiation therapy, and bone marrow or peripheral stem cell transplantation in treating patients who have primary CNS germ cell tumors.

Trial Health

60
Monitor

Trial Health Score

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

Geographic Reach
3 countries

4 active sites

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

December 1, 2000

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2004

First QC Date

October 11, 2001

Last Update Submit

December 17, 2013

Conditions

Brain and Central Nervous System Tumors

Keywords

childhood central nervous system germ cell tumoradult central nervous system germ cell tumor

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
cyclophosphamideDRUG
etoposideDRUG
thiotepaDRUG
autologous bone marrow transplantationPROCEDURE
bone marrow ablation with stem cell supportPROCEDURE
conventional surgeryPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed primary CNS germ cell tumor OR * Serum or cerebrospinal fluid (CSF) elevation of alpha-fetoprotein (AFP) or beta-human chorionic gonadotropin (beta-HCG) greater than 50 ng/mL * Low-risk disease: * Histologically proven pure germinoma * Localized, nonmetastatic disease * Normal CSF * Normal serum tumor markers * Intermediate-risk disease: * Histologically proven germinoma * Beta-HCG-positive syncytiotrophoblastic giant cell component AND/OR * CSF elevation of beta-HCG to less than 50 ng/mL * High-risk disease: * Histologically proven choriocarcinoma, endodermal sinus tumor, or embryonal carcinoma * Elevated serum and/or CSF AFP OR * Elevated serum beta-HCG OR * Elevated CSF beta-HCG greater than 50 ng/mL OR * Disseminated disease by MRI and/or CSF cytology PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2.0 mg/dL * Indirect hyperbilirubinemia due to Gilbert's syndrome is allowed * AST and ALT less than 5 times upper limit of normal Renal: * Creatinine clearance greater than 60 mL/min Cardiovascular: * Cardiac function normal by echocardiogram * No myocardial infarction or ischemia in patients over 30 years * Fractional shortening greater than 30% Other: * No unacceptable morbidity of organ systems outside the CNS * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * No concurrent corticosteroids administered solely for antiemesis during study chemotherapy Radiotherapy: * No prior cranial radiotherapy 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 (4)

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Children's Hospital of the King's Daughters

Norfolk, Virginia, 23507, United States

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

FilgrastimCarboplatinCyclophosphamideEtoposideThiotepaPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Jonathan L. Finlay, MB, ChB

    Children's Hospital Los Angeles

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 11, 2001

First Posted

January 27, 2003

Study Start

December 1, 2000

Last Updated

December 18, 2013

Record last verified: 2004-12

Locations

CA(1)AU(1)US(2)