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

Sponsor:	Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00526318

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:	Treatment, Randomized, Active Control
Official Title:	Trial Protocol for the Treatment of Children With High Risk Neuroblastoma (NB2004-HR)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Neuroblastoma

Drug Information available for: Cyclophosphamide Vincristine Cisplatin Doxorubicin Doxorubicin hydrochloride Etoposide Carboplatin Vindesine 3-Iodobenzylguanidine Iobenguane Myocet Etoposide phosphate Topotecan hydrochloride Filgrastim Topotecan Melphalan Sarcolysin Vincristine sulfate Melphalan hydrochloride Ifosfamide Dacarbazine Isotretinoin

U.S. FDA Resources

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)

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Contacts and Locations

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

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Locations

Germany
Carl - Thiem - Klinkum Cottbus	Recruiting
Cottbus, Germany, D-03048
Contact: D Mobius, MD 49-355-462336
Charite University Hospital - Campus Virchow Klinikum	Recruiting
Berlin, Germany, D-13353
Contact: Gunter Henze 49-30-450-660-31
Children's Hospital	Recruiting
Cologne, Germany, D-50924
Contact: Frank Berthold, MD 49-221-478-4380 frank.berthold@uk-koeln.de
Cnopf'sche Kinderklinik	Recruiting
Nuremberg, Germany, 90419
Contact: W. Scheurlen 49-911-334-002
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
Dr. von Haunersches Kinderspital der Universitaet Muenchen	Recruiting
Munich, Germany, D-80337
Contact: Irene Schmid, MD 49-89-5160-7978
Evangelisches Krankenhauus Bielfeld	Recruiting
Biefeld, Germany, 33617
Contact: N. Jorch, MD 49-52-177-278-050
Gemeinschaftskrankenhaus	Recruiting
Herdecke, Germany, 58313
Contact: Christoph Tautz, MD 49-2330-62-3914 ctautz@yahoo.de
Helios Kliniken Wuppertal University Hospital	Recruiting
Wuppertal, Germany, D-42283
Contact: K. Sinha, MD 49-202-896-2441
Helios Klinikum Berlin	Recruiting
Berlin, Germany, 13125
Contact: Lothar Schweigerer, MD 49-30-9401-2345
Helios Klinikum Erfurt	Recruiting
Erfurt, Germany, 99089
Contact: Axel Sauerbrey, MD 49-361-781-3729 asauerbrey@erfurt.helios-kliniken.de
Johannes Gutenberg University	Recruiting
Mainz, Germany, D-55101
Contact: P. Gutjahr, MD 49-6131-17-2112
Johanniter-Kinderklinik	Recruiting
St. Augustin, Germany, 53757
Contact: Roswitha Dickerhoff, MD 49-22-41-2491 roswitha.dickerhoft@uni-bonn.de
Kinderklinik - Universitaetsklinikum Aachen	Recruiting
Aachen, Germany, D-52074
Contact: R. Mertens, MD, PhD 49-241-808-9902 rmertens@ukaachen.de
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
Kinderklinik der Universitaet Bonn	Recruiting
Bonn, Germany, D-53113
Contact: Udo Bode, MD 49-228-2873-3215 udo.bode@ukb.uni-bonn.de
Kinderklinik	Recruiting
Giessen, Germany, D-35385
Contact: Alfred Reiter, MD 49-641-994-3420
Klinikum Neubrandenburg	Recruiting
Neubrandenburg, Germany, 17036
Contact: H. J. Feickert, MD, PhD 49-395-775-2901 feickerthj@dbk-nb.de
Klinik St. Hedwig-Kinderklinik	Recruiting
Regensburg, Germany, 93049
Contact: Ove Peters 49-941-369-5404
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
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
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
Klinikum der J.W. Goethe Universitaet	Recruiting
Frankfurt, Germany, D-60590
Contact: Thomas Klingebiel, MD 49-69-6301-5094 thomas.klingebiel@kgu.de
Klinikum Dortmund	Recruiting
Dortmund, Germany, D-44137
Contact: Dominik T. Schneider, MD 49-231-953-2-1670 dominik.schneider@klinikumdo.de
Klinikum Duisburg	Recruiting
Duisburg, Germany, D-47055
Contact: Ruef, MD 49-203-733-2421
Klinikum Kassel	Recruiting
Kassel, Germany, D-34125
Contact: Martina Rodehueser, MD 49-561-980-3066
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
Klinikum Lippe - Detmold	Recruiting
Detmold, Germany, D-32756
Contact: Klaus Wesseler, MD 49-523-172-4511
Klinikum Minden	Recruiting
Minden, Germany, D-32423
Contact: Bernhard Erdlenbruch, MD 49-57-1801-4601 bernhard.erdlenbruch@klinikum-minden.de
Kinderklink Siegen Deutsches Rotes Kreuz	Recruiting
Siegen, Germany, D-57072
Contact: Rainer Burghard, MD 49-271-2345-0 rainer.burghard@drk-kinderklinik.de
Klinikum Oldenburg	Recruiting
Oldenburg, Germany, 26133
Contact: Hermann Mueller, MD 49-441-403-2013 mueller.hermann@klinikum-oldenburg.de
Krankenanstalt Mutterhaus der Borromaerinnen	Recruiting
Trier, Germany, D-54290
Contact: Wolfgang Rauh, MD 49-651-947-2654
Krankenhaus Muenchen Schwabing	Recruiting
Munich, Germany, 80804
Contact: Stefan Burdach, MD, PhD 49-89-3068-2352
Krankenhaus St. Elisabeth und St. Barbara	Recruiting
Halle, Germany, D-06110
Contact: G. Guenther, MD 49-345-482-50
Medizinische Hochschule Hannover	Recruiting
Hannover, Germany, D-30625
Contact: Karl Welte, MD 49-511-532-6710 welte.karl.h@mh-hannover.de
Olgahospital	Recruiting
Stuttgart, Germany, D-70176
Contact: Stefan Bielack, MD 49-711-99-24-61 st.bielack@olgahospital.de
St. Annastift Krankenhaus	Recruiting
Ludwigshafen, Germany, 67065
Contact: Barbara Selle, MD 49-621-5702-4449
Staedtisches Klinik - Kinderklinik	Recruiting
Mannheim, Germany, D-68167
Contact: M. Duerken 49-621-383-2243
Staedtisches Klinikum - Howedestrase	Recruiting
Braunschweig, Germany, 38118
Contact: Wolfgang Eberl, MD 49-531-595-1222 w.eberl@kliniklum-braunschweig.de
Universitaetsklinikum des Saarlandes	Recruiting
Homburg, Germany, 66421
Contact: Norbert Graf 49-6841-162-4000
Universitaets - Kinderklinik - Luebeck	Recruiting
Luebeck, Germany, D-23538
Contact: Peter P. Bucsky, MD 49-451-500-2956 bucsky@paedia.ukl.mu-luebeck.de
Universitaets - Kinderklinik Wuerzburg	Recruiting
Wuerzburg, Germany, D-97080
Contact: P. G. Schlegel, MD 49-931-201-27-831 schlegel@mail.uni-wuerzburg.de
Universitaets - Kinderklinik	Recruiting
Jena, Germany, D-07745
Contact: Felix Zintl, MD 49-3641-938-270
Universitaets - Kinderklinik	Recruiting
Erlangen, Germany, 91054
Contact: W. Holter, MD 49-9131-853-3118
Universitaets - Kinderklinik	Recruiting
Leipzig, Germany, D-04317
Contact: U. Bierbach, MD Not Available
Universitaetskinderklinik - Universitaetsklinikum Freiburg	Recruiting
Freiburg, Germany, D-79106
Contact: Charlotte Niemeyer, MD 49-761-270-4506 charlotte.niemeyer@uniklinik-freiburg.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
Staedtisches Klinikum Karlsruhe gGmbH	Recruiting
Karlsruhe, Germany, 76133
Contact: A. Leipold 49-721-974-3311
Universitaetsklinikum Duesseldorf	Recruiting
Duesseldorf, Germany, D-40225
Contact: Arndt Borkhardt 49-211-311-7990
Universitaetsklinikum Essen	Recruiting
Essen, Germany, D-45147
Contact: Bernhard Kremens, MD 49-201-723-2453
Universitaetsklinikum Giessen und Marburg GmbH - Marburg	Recruiting
Marburg, Germany, D-35043
Contact: H. Christiansen, MD 49-6421-286-2671
Universitaetsklinikum Goettingen	Recruiting
Goettingen, Germany, D-37075
Contact: M. Lakomek, MD 49-551-398-600
Universitaetsklinikum Halle	Recruiting
Halle, Germany, D-06097
Contact: Dieter Koerholz, MD 49-345-557-2387
Universitatsklinikum Carl Gustav Carus	Recruiting
Dresden, Germany, D-01307
Contact: M. Suttorp, MD 49-351-458-0 meinolf.suttorp@uniklinikum-dresden.de
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg	Recruiting
Magdeburg, Germany, D-39120
Contact: P. Vorwerk, MD 49-394-672-791
Universitats - Kinderklinik	Recruiting
Greiswald, Germany, 17487
Contact: James F. Beck, MD 49-383-486-6325 beck@uni-greifswald.de
Universitaetsklinikum Tuebingen	Recruiting
Tuebingen, Germany, D-72076
Contact: Rupert Handgretinger, MD 49-7071-298-2087
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
University Medical Center Hamburg - Eppendorf	Recruiting
Hamburg, Germany, D-20246
Contact: Rudolf Erttmann, MD 49-40-4717-4270 erttmann@uke.uni-hamburg.de
Vestische Kinderklinik	Recruiting
Datteln, Germany, 45704
Contact: W. Andler, MD 49-023-63-9750 w.andler@kinderklinik-datteln.de
Switzerland
Kantonspital Aarau	Recruiting
Aarau, Switzerland, CH-5001
Contact: R. Angst 41-62-838-4906
University Children's Hospital	Recruiting
Zurich, Switzerland, CH-8032
Contact: Felix Niggli, MD 41-44-266-7823
Ostschweizer Kinderspital	Recruiting
St. Gallen, Switzerland, CH-9006
Contact: Jeanette Greiner, MD 41-71-243-13-60 jeanette.greiner@kispisg.ch
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

Sponsors and Collaborators

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

Investigators

Study Chair:

Frank Berthold, MD

Children's Hospital

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

Study ID Numbers:	CDR0000564820, GPOH-NB2004-HR, UNI-KOELN-161
Study First Received:	September 5, 2007
Last Updated:	May 7, 2009
ClinicalTrials.gov Identifier:	NCT00526318 History of Changes
Health Authority:	Unspecified