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Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

  Purpose

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.

Condition	Intervention	Phase
Neuroblastoma	Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: melphalan Drug: tretinoin Drug: vincristine sulfate Drug: vindesine Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Neuroblastoma Study Phase II Study of Various Therapies in Patients With Neuroblastoma

Resource links provided by NLM:

Genetics Home Reference related topics: neuroblastoma

MedlinePlus related topics: Bone Marrow Transplantation Cancer Neuroblastoma

Drug Information available for: Cyclophosphamide Melphalan Tretinoin Vincristine sulfate Melphalan hydrochloride Ifosfamide Dacarbazine Cisplatin Doxorubicin Doxorubicin hydrochloride Etoposide Carboplatin Etoposide phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 1997

  Show Detailed Description

  Eligibility

Ages Eligible for Study:	up to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017225

  Hide Study Locations

Locations

Germany

Urologische Klinik - Universitaetsklinikum Aachen

Aachen, Germany, D-52074

Zentralklinikum Augsburg

Augsburg, Germany, DOH-86156

Kinderkrankenhaus Josefinum

Augsburg, Germany, 86154

Caritaskrankenhaus

Bad Mergentheim, Germany, 97980

Klinikum Bayreuth

Bayreuth, Germany, 95445

Charite - Campus Virchow Klinikum

Berlin, Germany, D-13353

Helios Klinikum Berlin

Berlin, Germany, 13122

Krankenanstalten Gilead

Biefeld, Germany, 33617

Kinderklinik der Universitaet-Bonn

Bonn, Germany, DOH-53113

Stadt Klinikum - Howedestrase

Braunschweig, Germany, 38118

Zentralkrankenhaus

Bremen, Germany, D-28205

Klinikum Chemnitz GMBH

Chemnitz, Germany, D-09116

Klinikum Coburg

Coburg, Germany, 96450

Medizinische Universitaetsklinik I

Cologne, Germany, D-50924

Carl - Thiem - Klinkum Cottbus

Cottbus, Germany, D-03048

Vestische Kinderklinik

Datteln, Germany, 45704

Klinikum Lippe - Detmold

Detmold, Germany, 32756

Stadt. Kliniken

Dortmund, Germany, 44123

Universitatsklinikum Carl Gustav Carl Carus

Dresden, Germany, D-01307

Stadt. KH Dresden - Neustadt

Dresden, Germany, 01229

Universitaetsklinik Duesseldorf

Duesseldorf, Germany, D-40225

Helios Klinikum Erfurt GmbH

Erfurt, Germany, 99012

Universitaets - Kinderklinik

Erlangen, Germany, D-91054

Universitaetsklinikum Essen

Essen, Germany, D-45122

Klinikum der J.W. Goethe Universitaet

Frankfurt, Germany, D-60590

Universitaetskinderklinik - Universitaetsklinikum Freiburg

Freiburg, Germany, 79106

Stadt. Kinderklinik

Gelsenkirchen, Germany, 45892

Kinderklinik

Giessen, Germany, D-35385

Universitaetsklinikum Goettingen

Goettingen, Germany, D-37075

Universitats - Kinderklinik

Greiswald, Germany, 17487

Kreiskrankenhaus Gummersbach GMBH

Gummersbach, Germany, D-51643

St. Barbara Krankenhaus

Halle, Germany, 06003

Martin Luther Universitaet

Halle, Germany, 06097

Universitaets-Krankenhaus Eppendorf

Hamburg, Germany, D-20246

Altonaer Kinderkrankenhaus

Hamburg, Germany, 22763

Evangelische Krankenhaus Hamm

Hamm, Germany, DOH-59063

Kinderkrankenhaus auf der Bult

Hannover, Germany, 30173

Medizinische Hochschule Hannover

Hannover, Germany, D-30625

Universitaets-Kinderklinik Heidelberg

Heidelberg, Germany, D-69120

Gemeinschaftskrankenhaus

Herdecke, Germany, 58313

Marien Hospital

Homburg, Germany, D-66421

Universitatsklinik Homburg

Homburg, Germany, 66421

Praxis am Evangelischen Krankenhaus Bethanien

Iserlohn, Germany, D-58644

Universitaets - Kinderklinik

Jena, Germany, D-07745

Westpfalz-Klinikum GmbH

Kaiserslautern, Germany, D-67653

Stadt. Kinderklinik

Karlsruhe, Germany, 76131

Kinderkrankenhaus

Kassel, Germany, 34121

Klinikum Kassel

Kassel, Germany, D-34125

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, Germany, D-24105

Staedtische Krankenhaus Kiel

Kiel, Germany, 23116

Stadt. Krankenhaus Kemperhof

Koblenz, Germany, 56065

Staedtisches Kinderkrankenhaus

Koln - Riehl, Germany, D-50735

Klinik Konstanz

Konstanz, Germany, 78461

Klinikum Krefeld GmbH

Krefeld, Germany, D-47805

Universitaets Klinik fuer Kinderchirurgie

Leipzig, Germany, D-04317

Universitaets - Kinderklinik

Leipzig, Germany, 04317

Universitaets - Kinderklinik - Luebeck

Lubeck, Germany, 23538

St. Annastift Krankenhaus

Ludwigshafen, Germany, 67065

Universitatsklinikum der MA

Magdeburg, Germany, 39112

Johannes Gutenberg University

Mainz, Germany, D-55131

Stadt. Klinik - Kinderklinik

Mannheim, Germany, 68167

Universitaets - Kinderklinik

Marburg, Germany, 35033

Klinikum Minden

Minden, Germany, D-32423

Klinik und Poliklinik fuer Kinderheilkunde - Universitaetsklinikum Muenster

Muenster, Germany, D-48149

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, Germany, D-81545

Kinderklinik

Munich, Germany, DOH-80337

Kinderklinik d. TU / Schwabing

Munich, Germany, 80804

Universitaets - Kinderpoliklinik

Munich, Germany, 80336

Kinderklinik Kohlhof

Neunkirchen, Germany, 66539

Cnopfche Kinderklinik

Nuernberg, Germany, 90419

Klinikum Oldenburg

Oldenburg, Germany, 26133

Kindershospital

Osnabruck, Germany, D-49082

Krankenhaus D Barmherzigen Brueder

Regensburg, Germany, 93049

Staedtische Klinikum-Kinderklinik

Rosenheim, Germany, 83022

Kinderklinik - Universitaetsklinikum Rostock

Rostock, Germany, D-18057

Saarbrucker Winterbergkliniken

Saarbrucken, Germany, 66119

Diakone - Krankenhaus

Schwabisch Hall, Germany, 74523

Klinikum Schwerin

Schwerin, Germany, D-19049

Leopoldina - Krankenhaus

Schwienfurt, Germany, 97422

Deutsches Rotes Kreuz

Siegen, Germany, 57072

Johanniter-Kinderklinik

St. Augustin, Germany, 53757

Olgahospital

Stuttgart, Germany, DOH-70176

Mutterhaus der Borromaerinnen

Trier, Germany, D-54290

Universitaetsklinikum Tuebingen

Tuebingen, Germany, D-72076

Universitaet Ulm

Ulm, Germany, D-89075

St. Marien Hospital

Vechta, Germany, D-49377

Reinhard - Nieter - Krankenhaus

Wilhelmshaven, Germany, 26389

Universitaets - Kinderklinik Wuerzburg

Wuerzburg, Germany, D-97080

Helios Klinikum Wuppertal

Wuppertal, Germany, D-42283

Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands, 6202 AZ

Switzerland

University Children's Hospital

Basel, Switzerland, CH-4005

Ospedale "la Carita", Locarno

Locarno, Switzerland, 6600

Kinderspital Luzerne

Luzerne 16, Switzerland, CH-6000

University Children's Hospital

Zurich, Switzerland, CH-8032

Sponsors and Collaborators

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

Investigators

Study Chair:

Frank Berthold, MD

Children's Hospital Medical Center, Cincinnati

  More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database 

Publications:

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.

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. Epub 2002 Feb 01.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00017225     History of Changes
Other Study ID Numbers:	CDR0000068664, GPOH-GERMANY-NB97, EU-20102, GER-GPOH-NB97
Study First Received:	June 6, 2001
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma

stage 4S neuroblastoma recurrent neuroblastoma localized unresectable neuroblastoma

Additional relevant MeSH terms:

Neuroblastoma Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Isophosphamide mustard Cisplatin Cyclophosphamide Dacarbazine Doxorubicin

Etoposide Ifosfamide Melphalan Tretinoin Vincristine Vindesine Carboplatin Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013

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