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Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00526318
First received: September 5, 2007
Last updated: August 6, 2013
Last verified: August 2011
  Purpose

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or by killing them. It also prepares the patient's bone marrow for the stem cell transplant. The stem cells are given to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving isotretinoin after transplant may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given before a stem cell transplant and isotretinoin in treating neuroblastoma.

PURPOSE: This randomized clinical trial is studying two different combination chemotherapy regimens to compare how well they work when given before a stem cell transplant and isotretinoin in treating young patients with high-risk neuroblastoma.


Condition Intervention
Neuroblastoma
Biological: filgrastim
Drug: carboplatin
Drug: cisplatin
Drug: cyclophosphamide
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: etoposide phosphate
Drug: ifosfamide
Drug: isotretinoin
Drug: melphalan
Drug: topotecan hydrochloride
Drug: vincristine sulfate
Drug: vindesine
Procedure: autologous hematopoietic stem cell transplantation
Radiation: iobenguane I 131
Radiation: radiation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Event-free survival (EFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival (OS) [ Designated as safety issue: No ]
  • Impact of well established clinical and molecular risk factors on EFS and OS [ Designated as safety issue: No ]
  • Early response, measured after 2 courses of induction chemotherapy [ Designated as safety issue: No ]
  • Response to induction therapy, measured before autologous stem cell transplantation [ Designated as safety issue: No ]
  • Toxicity during the first 2 courses and the last 6 courses of induction chemotherapy [ Designated as safety issue: Yes ]
  • Impact of the extent of initial and best surgery on outcome and frequency of complications [ Designated as safety issue: No ]
  • Acute and late toxicity of radiotherapy [ Designated as safety issue: Yes ]
  • Correlation of MIBG activity with whole-body radiation dose [ Designated as safety issue: No ]
  • Molecular markers (MYCN and status of chromosome 1p and 11q) [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: January 2007
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of neuroblastoma according to any of the following criteria:

    • Histological diagnosis from tumor tissue
    • Presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine
  • High-risk disease, meeting 1 of the following criteria:

    • Stage 4 disease, regardless of the MYCN status (1-21 years of age)
    • Stage 1-3 or 4S disease with MYCN amplification (6 months -21 years of age)

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception (hormonal contraception or intra-uterine device [IUD])

PRIOR CONCURRENT THERAPY:

  • No concurrent participation in another clinical trial that would preclude the interventions or outcome assessment of this clinical trial
  • No other concurrent anticancer therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526318

  Hide Study Locations
Locations
Germany
Kinderklinik - Universitaetsklinikum Aachen Recruiting
Aachen, Germany, D-52074
Contact: R. Mertens, MD, PhD    49-241-808-9902    rmertens@ukaachen.de   
Klinikum Augsburg Recruiting
Augsburg, Germany, DOH-86156
Contact: Astrid Gnekow    49-821-400-3603      
Klinikum Bayreuth Recruiting
Bayreuth, Germany, D-95445
Contact: T. Rupprecht    49-921-400-1400      
Charite University Hospital - Campus Virchow Klinikum Recruiting
Berlin, Germany, D-13353
Contact: Gunter Henze    49-30-450-660-31      
Helios Klinikum Berlin Recruiting
Berlin, Germany, 13125
Contact: Lothar Schweigerer, MD    49-30-9401-2345      
Evangelisches Krankenhauus Bielfeld Recruiting
Biefeld, Germany, 33617
Contact: N. Jorch, MD    49-52-177-278-050      
Kinderklinik der Universitaet Bonn Recruiting
Bonn, Germany, D-53113
Contact: Udo Bode, MD    49-228-2873-3215    udo.bode@ukb.uni-bonn.de   
Staedtisches Klinikum - Howedestrase Recruiting
Braunschweig, Germany, 38118
Contact: Wolfgang Eberl, MD    49-531-595-1222    w.eberl@kliniklum-braunschweig.de   
Klinikum Bremen-Mitte Recruiting
Bremen, Germany, D-28205
Contact: Arnulf Pekrun, MD, PhD    49-421-497-3656    arnulf.pekrun@klinikum-bremen-mitte.de   
Klinikum Chemnitz gGmbH Recruiting
Chemnitz, Germany, D-09116
Contact: Krause, MD    49-371-3332-4124      
Klinikum Coburg Recruiting
Coburg, Germany, 96450
Contact: Roland Frank, MD    49-9561-22-5547      
Children's Hospital Recruiting
Cologne, Germany, D-50924
Contact: Frank Berthold, MD    49-221-478-4380    frank.berthold@uk-koeln.de   
Carl - Thiem - Klinkum Cottbus Recruiting
Cottbus, Germany, D-03048
Contact: D Mobius, MD    49-355-462336      
Vestische Kinderklinik Recruiting
Datteln, Germany, 45704
Contact: W. Andler, MD    49-023-63-9750    w.andler@kinderklinik-datteln.de   
Klinikum Lippe - Detmold Recruiting
Detmold, Germany, D-32756
Contact: Klaus Wesseler, MD    49-523-172-4511      
Klinikum Dortmund Recruiting
Dortmund, Germany, D-44137
Contact: Dominik T. Schneider, MD    49-231-953-2-1670    dominik.schneider@klinikumdo.de   
Universitatsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, D-01307
Contact: M. Suttorp, MD    49-351-458-0    meinolf.suttorp@uniklinikum-dresden.de   
Universitaetsklinikum Duesseldorf Recruiting
Duesseldorf, Germany, D-40225
Contact: Arndt Borkhardt    49-211-311-7990      
Klinikum Duisburg Recruiting
Duisburg, Germany, D-47055
Contact: Ruef, MD    49-203-733-2421      
Helios Klinikum Erfurt Recruiting
Erfurt, Germany, 99089
Contact: Axel Sauerbrey, MD    49-361-781-3729    asauerbrey@erfurt.helios-kliniken.de   
Universitaets - Kinderklinik Recruiting
Erlangen, Germany, 91054
Contact: W. Holter, MD    49-9131-853-3118      
Universitaetsklinikum Essen Recruiting
Essen, Germany, D-45147
Contact: Bernhard Kremens, MD    49-201-723-2453      
Klinikum der J.W. Goethe Universitaet Recruiting
Frankfurt, Germany, D-60590
Contact: Thomas Klingebiel, MD    49-69-6301-5094    thomas.klingebiel@kgu.de   
Universitaetskinderklinik - Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany, D-79106
Contact: Charlotte Niemeyer, MD    49-761-270-4506    charlotte.niemeyer@uniklinik-freiburg.de   
Kinderklinik Recruiting
Giessen, Germany, D-35385
Contact: Alfred Reiter, MD    49-641-994-3420      
Universitaetsklinikum Goettingen Recruiting
Goettingen, Germany, D-37075
Contact: M. Lakomek, MD    49-551-398-600      
Universitats - Kinderklinik Recruiting
Greiswald, Germany, 17487
Contact: James F. Beck, MD    49-383-486-6325    beck@uni-greifswald.de   
Krankenhaus St. Elisabeth und St. Barbara Recruiting
Halle, Germany, D-06110
Contact: G. Guenther, MD    49-345-482-50      
Universitaetsklinikum Halle Recruiting
Halle, Germany, D-06097
Contact: Dieter Koerholz, MD    49-345-557-2387      
University Medical Center Hamburg - Eppendorf Recruiting
Hamburg, Germany, D-20246
Contact: Rudolf Erttmann, MD    49-40-4717-4270    erttmann@uke.uni-hamburg.de   
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, D-30625
Contact: Karl Welte, MD    49-511-532-6710    welte.karl.h@mh-hannover.de   
Universitaets-Kinderklinik Heidelberg Recruiting
Heidelberg, Germany, D-69120
Contact: Andreas E. Kulozik, MD, PhD    49-6221-564-555    andreas.kulozik@med.uni-heidelberg.de   
Gemeinschaftskrankenhaus Recruiting
Herdecke, Germany, 58313
Contact: Christoph Tautz, MD    49-2330-62-3914    ctautz@yahoo.de   
Universitaetsklinikum des Saarlandes Recruiting
Homburg, Germany, 66421
Contact: Norbert Graf    49-6841-162-4000      
Universitaets - Kinderklinik Recruiting
Jena, Germany, D-07745
Contact: Felix Zintl, MD    49-3641-938-270      
Staedtisches Klinikum Karlsruhe gGmbH Recruiting
Karlsruhe, Germany, 76133
Contact: A. Leipold    49-721-974-3311      
Klinikum Kassel Recruiting
Kassel, Germany, D-34125
Contact: Martina Rodehueser, MD    49-561-980-3066      
University Hospital Schleswig-Holstein - Kiel Campus Recruiting
Kiel, Germany, D-24105
Contact: A. Claviez, MD    49-431-597-1622    a.claviez@pediatrics.uni-kiel.de   
Klinikum Kemperhof Koblenz Recruiting
Koblenz, Germany, D-56065
Contact: M. Rister, MD    49-261-499-2602      
Klinikum Krefeld GmbH Recruiting
Krefeld, Germany, D-47805
Contact: S. Volpel, MD    49-2151-32-2375      
Universitaets - Kinderklinik Recruiting
Leipzig, Germany, D-04317
Contact: U. Bierbach, MD         
St. Annastift Krankenhaus Recruiting
Ludwigshafen, Germany, 67065
Contact: Barbara Selle, MD    49-621-5702-4449      
Universitaets - Kinderklinik - Luebeck Recruiting
Luebeck, Germany, D-23538
Contact: Peter P. Bucsky, MD    49-451-500-2956    bucsky@paedia.ukl.mu-luebeck.de   
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg Recruiting
Magdeburg, Germany, D-39120
Contact: P. Vorwerk, MD    49-394-672-791      
Johannes Gutenberg University Recruiting
Mainz, Germany, D-55101
Contact: P. Gutjahr, MD    49-6131-17-2112      
Staedtisches Klinik - Kinderklinik Recruiting
Mannheim, Germany, D-68167
Contact: M. Duerken    49-621-383-2243      
Universitaetsklinikum Giessen und Marburg GmbH - Marburg Recruiting
Marburg, Germany, D-35043
Contact: H. Christiansen, MD    49-6421-286-2671      
Klinikum Minden Recruiting
Minden, Germany, D-32423
Contact: Bernhard Erdlenbruch, MD    49-57-1801-4601    bernhard.erdlenbruch@klinikum-minden.de   
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster Recruiting
Muenster, Germany, D-48149
Contact: Heribert F. Juergens, MD    49-251-834-7742    jurgh@uni-muenster.de   
Dr. von Haunersches Kinderspital der Universitaet Muenchen Recruiting
Munich, Germany, D-80337
Contact: Irene Schmid, MD    49-89-5160-7978      
Krankenhaus Muenchen Schwabing Recruiting
Munich, Germany, 80804
Contact: Stefan Burdach, MD, PhD    49-89-3068-2352      
Klinikum Neubrandenburg Recruiting
Neubrandenburg, Germany, 17036
Contact: H. J. Feickert, MD, PhD    49-395-775-2901    feickerthj@dbk-nb.de   
Cnopf'sche Kinderklinik Recruiting
Nuremberg, Germany, 90419
Contact: W. Scheurlen    49-911-334-002      
Klinikum Oldenburg Recruiting
Oldenburg, Germany, 26133
Contact: Hermann Mueller, MD    49-441-403-2013    mueller.hermann@klinikum-oldenburg.de   
Klinik St. Hedwig-Kinderklinik Recruiting
Regensburg, Germany, 93049
Contact: Ove Peters    49-941-369-5404      
Kinderklinik - Universitaetsklinikum Rostock Recruiting
Rostock, Germany, D-18057
Contact: Carl Friedrich Classen, MD, PD    49-381-494-0    carl-friedrich.classen@med.uni-rostock.de   
Kinderklink Siegen Deutsches Rotes Kreuz Recruiting
Siegen, Germany, D-57072
Contact: Rainer Burghard, MD    49-271-2345-0    rainer.burghard@drk-kinderklinik.de   
Johanniter-Kinderklinik Recruiting
St. Augustin, Germany, 53757
Contact: Roswitha Dickerhoff, MD    49-22-41-2491    roswitha.dickerhoft@uni-bonn.de   
Olgahospital Recruiting
Stuttgart, Germany, D-70176
Contact: Stefan Bielack, MD    49-711-99-24-61    st.bielack@olgahospital.de   
Krankenanstalt Mutterhaus der Borromaerinnen Recruiting
Trier, Germany, D-54290
Contact: Wolfgang Rauh, MD    49-651-947-2654      
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Germany, D-72076
Contact: Rupert Handgretinger, MD    49-7071-298-2087      
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm Recruiting
Ulm, Germany, D-89075
Contact: Klaus M. Debatin, MD    49-731-5002-7790    klaus-michael.debatin@medizin.uni-ulm.de   
Universitaets - Kinderklinik Wuerzburg Recruiting
Wuerzburg, Germany, D-97080
Contact: P. G. Schlegel, MD    49-931-201-27-831    schlegel@mail.uni-wuerzburg.de   
Helios Kliniken Wuppertal University Hospital Recruiting
Wuppertal, Germany, D-42283
Contact: K. Sinha, MD    49-202-896-2441      
Switzerland
Kantonsspital Aarau Recruiting
Aarau, Switzerland, CH-5001
Contact: R. Angst    41-62-838-4906      
Universitaets-Kinderspital beider Basel Recruiting
Basel, Switzerland, CH-4005
Contact: Thomas Kuhne, MD    41-61-685-6565    thomas.kuehne@ukbb.ch   
Kinderspital Luzern Recruiting
Lucerne 16, Switzerland, CH-6000
Contact: U. Caflisch, MD    41-41-205-11-11      
Ostschweizer Kinderspital Recruiting
St. Gallen, Switzerland, CH-9006
Contact: Jeanette Greiner, MD    41-71-243-13-60    jeanette.greiner@kispisg.ch   
University Children's Hospital Recruiting
Zurich, Switzerland, CH-8032
Contact: Felix Niggli, MD    41-44-266-7823      
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:
No publications provided

ClinicalTrials.gov Identifier: NCT00526318     History of Changes
Other Study ID Numbers: GPOH-NB2004-HR, CDR0000564820, UNI-KOELN-161, EU-20661
Study First Received: September 5, 2007
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
localized resectable neuroblastoma
localized unresectable neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
disseminated neuroblastoma

Additional relevant MeSH terms:
Neuroblastoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
3-Iodobenzylguanidine
Cyclophosphamide
Doxorubicin
Etoposide
Etoposide phosphate
Isotretinoin
Liposomal doxorubicin
Topotecan
Vincristine
Alkylating Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Dermatologic Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Immunologic Factors

ClinicalTrials.gov processed this record on November 25, 2014