NCT00017225

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. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Combining these therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with or without peripheral stem cell transplantation in treating patients who have neuroblastoma.

Trial Health

90
On Track

Trial Health Score

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

Timeline
Completed

Started May 1997

Longer than P75 for phase_2

Geographic Reach
3 countries

94 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

May 1, 1997

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

August 2, 2013

Status Verified

August 1, 2002

First QC Date

June 6, 2001

Last Update Submit

August 1, 2013

Conditions

Keywords

localized resectable neuroblastomaregional neuroblastomadisseminated neuroblastomastage 4S neuroblastomarecurrent neuroblastomalocalized unresectable neuroblastoma

Interventions

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed neuroblastoma * Observation stratum: * MYCN gene not amplified * Infants with stage I-IVS disease OR * Over 1 year of age and stage I or II resectable disease * Standard-risk stratum: * MYCN gene not amplified * Infants with serious symptoms and stage II-IVS disease OR * Over 1 year of age with stage II or III unresectable disease * High-risk stratum: * Stage IV disease OR * Stage I-IVS MYCN gene-amplified disease PATIENT CHARACTERISTICS: Age: * 20 and under Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * No kidney insufficiency Cardiovascular: * No cardiac insufficiency Other: * Not pregnant * Fertile patients must use effective contraception * No other serious illness PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy within 6 months after diagnosis Endocrine therapy: * Not specified Radiotherapy: * Not specified 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 (94)

Urologische Klinik - Universitaetsklinikum Aachen

Aachen, D-52074, Germany

Location

Kinderkrankenhaus Josefinum

Augsburg, 86154, Germany

Location

Zentralklinikum Augsburg

Augsburg, DOH-86156, Germany

Location

Caritaskrankenhaus

Bad Mergentheim, 97980, Germany

Location

Klinikum Bayreuth

Bayreuth, 95445, Germany

Location

Helios Klinikum Berlin

Berlin, 13122, Germany

Location

Charite - Campus Virchow Klinikum

Berlin, D-13353, Germany

Location

Krankenanstalten Gilead

Biefeld, 33617, Germany

Location

Kinderklinik der Universitaet-Bonn

Bonn, DOH-53113, Germany

Location

Stadt Klinikum - Howedestrase

Braunschweig, 38118, Germany

Location

Zentralkrankenhaus

Bremen, D-28205, Germany

Location

Klinikum Chemnitz GMBH

Chemnitz, D-09116, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

Medizinische Universitaetsklinik I

Cologne, D-50924, Germany

Location

Carl - Thiem - Klinkum Cottbus

Cottbus, D-03048, Germany

Location

Vestische Kinderklinik

Datteln, 45704, Germany

Location

Klinikum Lippe - Detmold

Detmold, 32756, Germany

Location

Stadt. Kliniken

Dortmund, 44123, Germany

Location

Stadt. KH Dresden - Neustadt

Dresden, 01229, Germany

Location

Universitatsklinikum Carl Gustav Carl Carus

Dresden, D-01307, Germany

Location

Universitaetsklinik Duesseldorf

Düsseldorf, D-40225, Germany

Location

Helios Klinikum Erfurt GmbH

Erfurt, 99012, Germany

Location

Universitaets - Kinderklinik

Erlangen, D-91054, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

Location

Universitaetskinderklinik - Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Stadt. Kinderklinik

Gelsenkirchen, 45892, Germany

Location

Kinderklinik

Giessen, D-35385, Germany

Location

Universitaetsklinikum Goettingen

Göttingen, D-37075, Germany

Location

Universitats - Kinderklinik

Greiswald, 17487, Germany

Location

Kreiskrankenhaus Gummersbach GMBH

Gummersbach, D-51643, Germany

Location

St. Barbara Krankenhaus

Halle, 06003, Germany

Location

Martin Luther Universitaet

Halle, 06097, Germany

Location

Altonaer Kinderkrankenhaus

Hamburg, 22763, Germany

Location

Universitaets-Krankenhaus Eppendorf

Hamburg, D-20246, Germany

Location

Evangelische Krankenhaus Hamm

Hamm, DOH-59063, Germany

Location

Kinderkrankenhaus auf der Bult

Hanover, 30173, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Universitaets-Kinderklinik Heidelberg

Heidelberg, D-69120, Germany

Location

Gemeinschaftskrankenhaus

Herdecke, 58313, Germany

Location

Universitatsklinik Homburg

Homburg, 66421, Germany

Location

Marien Hospital

Homburg, D-66421, Germany

Location

Praxis am Evangelischen Krankenhaus Bethanien

Iserlohn, D-58644, Germany

Location

Universitaets - Kinderklinik

Jena, D-07745, Germany

Location

Westpfalz-Klinikum GmbH

Kaiserslautern, D-67653, Germany

Location

Stadt. Kinderklinik

Karlsruhe, 76131, Germany

Location

Kinderkrankenhaus

Kassel, 34121, Germany

Location

Klinikum Kassel

Kassel, D-34125, Germany

Location

Staedtische Krankenhaus Kiel

Kiel, 23116, Germany

Location

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Stadt. Krankenhaus Kemperhof

Koblenz, 56065, Germany

Location

Staedtisches Kinderkrankenhaus

Koln - Riehl, D-50735, Germany

Location

Klinik Konstanz

Konstanz, 78461, Germany

Location

Klinikum Krefeld GmbH

Krefeld, D-47805, Germany

Location

Universitaets - Kinderklinik

Leipzig, 04317, Germany

Location

Universitaets Klinik fuer Kinderchirurgie

Leipzig, D-04317, Germany

Location

St. Annastift Krankenhaus

Ludwigshafen, 67065, Germany

Location

Universitaets - Kinderklinik - Luebeck

Lübeck, 23538, Germany

Location

Universitatsklinikum der MA

Magdeburg, 39112, Germany

Location

Johannes Gutenberg University

Mainz, D-55131, Germany

Location

Stadt. Klinik - Kinderklinik

Mannheim, 68167, Germany

Location

Universitaets - Kinderklinik

Marburg, 35033, Germany

Location

Klinikum Minden

Minden, D-32423, Germany

Location

Universitaets - Kinderpoliklinik

Munich, 80336, Germany

Location

Kinderklinik d. TU / Schwabing

Munich, 80804, Germany

Location

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, D-81545, Germany

Location

Kinderklinik

Munich, DOH-80337, Germany

Location

Klinik und Poliklinik fuer Kinderheilkunde - Universitaetsklinikum Muenster

Münster, D-48149, Germany

Location

Kinderklinik Kohlhof

Neunkirchen, 66539, Germany

Location

Cnopfche Kinderklinik

Nuremberg, 90419, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

Kindershospital

Osnabrück, D-49082, Germany

Location

Krankenhaus D Barmherzigen Brueder

Regensburg, 93049, Germany

Location

Staedtische Klinikum-Kinderklinik

Rosenheim, 83022, Germany

Location

Kinderklinik - Universitaetsklinikum Rostock

Rostock, D-18057, Germany

Location

Saarbrucker Winterbergkliniken

Saarbrücken, 66119, Germany

Location

Johanniter-Kinderklinik

Sankt Augustin, 53757, Germany

Location

Diakone - Krankenhaus

Schwäbisch Hall, 74523, Germany

Location

Klinikum Schwerin

Schwerin, D-19049, Germany

Location

Leopoldina - Krankenhaus

Schwienfurt, 97422, Germany

Location

Deutsches Rotes Kreuz

Siegen, 57072, Germany

Location

Olgahospital

Stuttgart, DOH-70176, Germany

Location

Mutterhaus der Borromaerinnen

Trier, D-54290, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Universitaet Ulm

Ulm, D-89075, Germany

Location

St. Marien Hospital

Vechta, D-49377, Germany

Location

Reinhard - Nieter - Krankenhaus

Wilhelmshaven, 26389, Germany

Location

Helios Klinikum Wuppertal

Wuppertal, D-42283, Germany

Location

Universitaets - Kinderklinik Wuerzburg

Würzburg, D-97080, Germany

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

University Children's Hospital

Basel, CH-4005, Switzerland

Location

Ospedale "la Carita", Locarno

Locarno, 6600, Switzerland

Location

Kinderspital Luzerne

Luzerne 16, CH-6000, Switzerland

Location

University Children's Hospital

Zurich, CH-8032, Switzerland

Location

Related Publications (13)

  • Krams M, Hero B, Berthold F, Parwaresch R, Harms D, Rudolph P. Proliferation marker KI-S5 discriminates between favorable and adverse prognosis in advanced stages of neuroblastoma with and without MYCN amplification. Cancer. 2002 Feb 1;94(3):854-61.

    PMID: 11857322BACKGROUND
  • Simon T, Hero B, Dupuis W, Selle B, Berthold F. The incidence of hearing impairment after successful treatment of neuroblastoma. Klin Padiatr. 2002 Jul-Aug;214(4):149-52. doi: 10.1055/s-2002-33179.

    PMID: 12165893BACKGROUND
  • Spitz R, Hero B, Westermann F, Ernestus K, Schwab M, Berthold F. Fluorescence in situ hybridization analyses of chromosome band 1p36 in neuroblastoma detect two classes of alterations. Genes Chromosomes Cancer. 2002 Jul;34(3):299-305. doi: 10.1002/gcc.10070.

    PMID: 12007190BACKGROUND
  • Hero B, Simon T, Spitz R, Ernestus K, Gnekow AK, Scheel-Walter HG, Schwabe D, Schilling FH, Benz-Bohm G, Berthold F. Localized infant neuroblastomas often show spontaneous regression: results of the prospective trials NB95-S and NB97. J Clin Oncol. 2008 Mar 20;26(9):1504-10. doi: 10.1200/JCO.2007.12.3349.

    PMID: 18349403BACKGROUND
  • Simon T, Hero B, Benz-Bohm G, von Schweinitz D, Berthold F. Review of image defined risk factors in localized neuroblastoma patients: Results of the GPOH NB97 trial. Pediatr Blood Cancer. 2008 May;50(5):965-9. doi: 10.1002/pbc.21343.

    PMID: 17914735BACKGROUND
  • Berthold F, Hero B, Kremens B, Handgretinger R, Henze G, Schilling FH, Schrappe M, Simon T, Spix C. Long-term results and risk profiles of patients in five consecutive trials (1979-1997) with stage 4 neuroblastoma over 1 year of age. Cancer Lett. 2003 Jul 18;197(1-2):11-7. doi: 10.1016/s0304-3835(03)00076-4.

    PMID: 12880954BACKGROUND
  • Spitz R, Hero B, Ernestus K, Berthold F. Deletions in chromosome arms 3p and 11q are new prognostic markers in localized and 4s neuroblastoma. Clin Cancer Res. 2003 Jan;9(1):52-8.

    PMID: 12538451BACKGROUND
  • Spitz R, Hero B, Ernestus K, Berthold F. FISH analyses for alterations in chromosomes 1, 2, 3, and 11 define high-risk groups in neuroblastoma. Med Pediatr Oncol. 2003 Jul;41(1):30-5. doi: 10.1002/mpo.10313.

    PMID: 12764740BACKGROUND
  • Spitz R, Hero B, Ernestus K, Berthold F. Gain of distal chromosome arm 17q is not associated with poor prognosis in neuroblastoma. Clin Cancer Res. 2003 Oct 15;9(13):4835-40.

    PMID: 14581355BACKGROUND
  • von Schweinitz D, Hero B, Berthold F. The impact of surgical radicality on outcome in childhood neuroblastoma. Eur J Pediatr Surg. 2002 Dec;12(6):402-9. doi: 10.1055/s-2002-36952.

    PMID: 12548494BACKGROUND
  • Simon T, Hero B, Bongartz R, Schmidt M, Muller RP, Berthold F. Intensified external-beam radiation therapy improves the outcome of stage 4 neuroblastoma in children > 1 year with residual local disease. Strahlenther Onkol. 2006 Jul;182(7):389-94. doi: 10.1007/s00066-006-1498-8.

  • Kremens B, Hero B, Esser J, Weinel P, Filger-Brillinger J, Fleischhack G, Graf N, Gruttner HP, Niemeyer C, Schulz A, Wickmann L, Berthold F. Ocular symptoms in children treated with human-mouse chimeric anti-GD2 mAb ch14.18 for neuroblastoma. Cancer Immunol Immunother. 2002 Apr;51(2):107-10. doi: 10.1007/s00262-001-0259-x. Epub 2002 Feb 1.

  • Decarolis B, Simon T, Krug B, Leuschner I, Vokuhl C, Kaatsch P, von Schweinitz D, Klingebiel T, Mueller I, Schweigerer L, Berthold F, Hero B. Treatment and outcome of Ganglioneuroma and Ganglioneuroblastoma intermixed. BMC Cancer. 2016 Jul 27;16:542. doi: 10.1186/s12885-016-2513-9.

MeSH Terms

Conditions

Neuroblastoma

Interventions

FilgrastimCarboplatinCisplatinCyclophosphamideDacarbazineDoxorubicinEtoposideIfosfamideMelphalanTretinoinVincristineVindesinePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, 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 FactorsCoordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsTriazenesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesOxazinesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsVitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicTerpenesDiterpenesPigments, BiologicalVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Frank Berthold, MD

    Children's Hospital Medical Center, Cincinnati

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2001

First Posted

January 27, 2003

Study Start

May 1, 1997

Study Completion

February 1, 2002

Last Updated

August 2, 2013

Record last verified: 2002-08

Locations