Observation, Combination Chemotherapy, Radiation Therapy, and/or Autologous Stem Cell Transplant in Treating Young Patients With Neuroblastoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00410631
First received: December 11, 2006
Last updated: August 6, 2013
Last verified: January 2008
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. This may allow more chemotherapy to be given so that more tumor cells are killed. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether observation is more effective than combination chemotherapy, radiation therapy, and/or autologous stem cell transplant in treating neuroblastoma.

PURPOSE: This randomized phase III and phase IV trial is studying observation, combination chemotherapy, radiation therapy, and/or autologous stem cell transplant to compare how well they work in treating young patients with neuroblastoma.


Condition Intervention Phase
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
Procedure: conventional surgery
Procedure: peripheral blood stem cell transplantation
Radiation: iobenguane I 131
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: NB2004 Trial Protocol for Risk Adapted Treatment of Children With Neuroblastoma

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 ]
  • Locoregional EFS [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from diagnosis to transition to stage 4 disease, to death from disease, or to the last follow-up (if no transition to stage 4 disease is observed) [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Time to the beginning of primary tumor regression (in patients in the low-risk group [LRG]) [ Designated as safety issue: No ]
  • Time to the normalization of tumor markers HVA and VMA in urine [ Designated as safety issue: No ]
  • Time to no evidence of disease (in patients in the LRG with stage 4S disease) [ Designated as safety issue: No ]
  • Status of the primary tumor 12 months after diagnosis (LRG) [ Designated as safety issue: No ]
  • Best status of the primary tumor within the first 12 months (LRG) [ Designated as safety issue: No ]
  • Status of chromosome 1p (unblinded) and status of chromosome 11q (blinded) [ Designated as safety issue: No ]
  • Comparison of the extent of initial surgery (incomplete resection vs macroscopic complete resection) (LRG) [ Designated as safety issue: No ]
  • Comparison of the extent of best surgery during protocol treatment (incomplete resection vs macroscopic complete resection) [ Designated as safety issue: No ]
  • Surgery-related complications (i.e., bleeding, infection, intestinal obstruction, or other) [ Designated as safety issue: No ]
  • Disease progression and symptoms controlled after the first, second, third, and fourth N4 course (LRG) [ Designated as safety issue: No ]
  • Disease progression and symptoms not controlled after four N4 courses (LRG) [ Designated as safety issue: No ]
  • Transition to stage 4 disease at any time (LRG) [ Designated as safety issue: No ]
  • Acute and late side effects of external-beam radiotherapy (medium-risk group [MRG] and high-risk group [HRG]) [ Designated as safety issue: Yes ]
  • Early response after 2 courses of induction therapy (N5 and N6 or two courses of N8) (HRG) [ Designated as safety issue: No ]
  • Response to induction therapy prior to conditioning therapy or after 280 days (HRG) [ Designated as safety issue: No ]
  • Grade of toxicity observed during induction therapy course 1 (N5 or N8) (HRG) [ Designated as safety issue: Yes ]
  • Grade of toxicity observed during induction therapy course 2 (N6 or N8) (HRG) [ Designated as safety issue: Yes ]
  • Frequency of grade 3 or 4 toxicity observed during the last 6 courses of induction therapy (3 courses of N5 and N6) (HRG) [ Designated as safety issue: Yes ]
  • Activity and whole body dose of radiotherapy [ Designated as safety issue: No ]

Estimated Enrollment: 642
Study Start Date: October 2004
Estimated Primary Completion Date: December 2010 (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 by histology using tumor tissue or as evidenced by the presence of distinct neuroblastoma cells in the bone marrow AND elevated catecholamine metabolites (i.e., homovanillic acid [HVA] and vanillylmandelic acid [VMA]) in blood or urine

    • Newly diagnosed disease (for patients in the low-risk group)
    • Diagnosis from tumor tissue (for patients in the medium-risk group)
  • Meets criteria for 1 of the following risk groups:

    • Low-risk group

      • No MYCN amplification AND meets 1 of the following criteria:

        • Stage 1 disease
        • Stage 2 disease with no chromosome 1p deletion or imbalance
        • Stage 3 disease with no chromosome 1p deletion or imbalance (for patients < 2 years of age)
        • Stage 4S disease (for patients < 1 year of age)
    • Medium-risk group

      • No MYCN amplification AND meets 1 of the following criteria:

        • Stage 2 disease with chromosome 1p deletion or imbalance
        • Stage 3 disease with chromosome 1p deletion or imbalance

          • Any chromosome 1p status (for patients ≥ 2 years of age)
        • Stage 4 disease (for patients < 1 year of age)
    • High-risk group, meeting 1 of the following criteria:

      • Any stage disease with MYCN amplification

        • Any MYCN status (for patients ≥ 1 year of age)

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • No prior nephrectomy or other mutilating surgery as initial surgery (for patients in the low-risk group)
  • 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: NCT00410631

  Hide Study Locations
Locations
Germany
Kinderklinik - Universitaetsklinikum Aachen Recruiting
Aachen, Germany, D-52074
Contact: R. Mertens, MD, PhD    49-241-809-222    rmertens@ukaachen.de   
Klinikum Augsburg Recruiting
Augsburg, Germany, DOH-86156
Contact: Astrid Gnekow    49-821-400-3603      
Klinikum am Bamberg Recruiting
Bamberg, Germany, 96049
Contact: Gloeckel, MD    49-951-506-0      
Klinikum Bayreuth Recruiting
Bayreuth, Germany, D-95445
Contact: T. Rupprecht    49-921-400-6202      
Charite University Hospital - Campus Virchow Klinikum Recruiting
Berlin, Germany, D-13353
Contact: Gunter Henze    49-30-450-566-004      
Helios Klinikum Berlin Recruiting
Berlin, Germany, D-13125
Contact: L. Wickmann, MD    49-30-9401-2353    lwickmann@berlin.helios-kliniken.de   
Evangelisches Krankenhauus Bielfeld Recruiting
Biefeld, Germany, 33617
Contact: N. Jorch, MD    49-521-7727-8050      
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: Contact Person    49-531-595-1222      
Klinikum Bremen-Mitte Recruiting
Bremen, Germany, D-28205
Contact: Arnulf Pekrun, MD, PhD    49-421-497-3656    arnulf.pekrun@klinikum-bremen-mitte.de   
Allgemeinen Krankenhaus Celle Kinderklinik Recruiting
Celle, Germany, 29223
Contact: Martin Kirschstein, MD    49-241-809-222    martin.kirschstein@akh-celle.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    49-8561-225-547      
Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl Recruiting
Cologne, Germany, D-50735
Contact: Contact Person    49-221-8907-5243      
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    49-355-462-336      
Vestische Kinderklinik Recruiting
Datteln, Germany, 45704
Contact: W. Andler, MD    49-2363-9750    w.andler@kinderklinik-datteln.de   
Klinikum Lippe - Detmold Recruiting
Detmold, Germany, D-32756
Contact: Klaus Wesseler, MD    49-5231-724-510      
Klinikum Dortmund Recruiting
Dortmund, Germany, D-44137
Contact: Heidi Olscheswski, MD    49-231-9532-1721      
Universitatsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, D-01307
Contact: M. Suttorp, MD    49-351-458-5035    meinolf.suttorp@uniklinikum-dresden.de   
Universitaets - Frauenklinik, Duesseldorf Recruiting
Duesseldorf, Germany, D-40225
Contact: Dilloo, MD    49-211-811-7680      
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    49-361-781-3702    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    49-69-6301-5243    thomas.klingebiel@kgu.de   
Universitaetskinderklinik - Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany, D-79106
Contact: Charlotte Niemeyer, MD    49-761-270-4552    charlotte.niemeyer@uniklinik-freiburg.de   
Kinderklinik Recruiting
Giessen, Germany, D-35385
Contact: Alfred Reiter, MD    49-641-994-3400      
Universitaetsklinikum Goettingen Recruiting
Goettingen, Germany, D-37075
Contact: Lothar Schweigerer, MD    49-551-396-210      
Universitats - Kinderklinik Recruiting
Greiswald, Germany, 17487
Contact: James F. Beck, MD    49-3834-866-325    beck@uni-greifswald.de   
Krankenhaus St. Elisabeth und St. Barbara Recruiting
Halle, Germany, D-06110
Contact: G. Guenther, MD    49-345-213-4514      
Universitaetsklinikum Halle Recruiting
Halle, Germany, D-06097
Contact: Dieter Koerholz, MD    49-345-557-2911      
University Medical Center Hamburg - Eppendorf Recruiting
Hamburg, Germany, D-20246
Contact: Rudolf Erttmann, MD    49-40-428-034-270    erttmann@uke.uni-hamburg.de   
Kinderkrankenhaus auf der Bult Recruiting
Hannover, Germany, 30173
Contact: U. Hofmann, MD    49-511-811-5424      
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, D-30625
Contact: Karl Welte, MD    49-511-532-9123    welte.karl.h@mh-hannover.de   
Universitaets-Kinderklinik Heidelberg Recruiting
Heidelberg, Germany, D-69120
Contact: Andreas E. Kulozik, MD, PhD    49-6221-562-311    andreas.kulozik@med.uni-heidelberg.de   
SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen Recruiting
Heilbronn, Germany, D-74064
Contact: Full, MD    49-7131-493-702      
Gemeinschaftskrankenhaus Recruiting
Herdecke, Germany, 58313
Contact: Christoph Tautz, MD    49-233-0620    ctautz@yahoo.de   
Universitaetsklinikum des Saarlandes Recruiting
Homburg, Germany, 66421
Contact: Norbert Graf    49-6841-162-4000      
Universitaets - Kinderklinik Recruiting
Jena, Germany, D-07440
Contact: Contact Peron    49-3641-938-270      
Universitaets - Kinderklinik Recruiting
Jena, Germany, D-07745
Contact: Felix Zintl, MD    49-3641-9300      
Staedtisches Klinikum Karlsruhe gGmbH Recruiting
Karlsruhe, Germany, 76133
Contact: A. Leipold    49-721-974-3230      
Kinderkrankenhaus Park Schoenfeld Recruiting
Kassel, Germany, D-34121
Contact: M. L. Wright, MD    49-561-928-5108      
Klinikum Kassel Recruiting
Kassel, Germany, D-34125
Contact: Martina Rodehueser, MD    49-561-9800      
University Hospital Schleswig-Holstein - Kiel Campus Recruiting
Kiel, Germany, D-24105
Contact: A. Claviez, MD    49-431-597-1620    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    49-2151-322-375      
St. Annastift Krankenhaus Recruiting
Ludwigshafen, Germany, 67065
Contact: Barbara Selle, MD    49-621-57021      
Universitaets - Kinderklinik - Luebeck Recruiting
Luebeck, Germany, D-23538
Contact: Peter P. Bucsky, MD    49-451-500-2956    bucsky@paedia.ukl.mu-luebeck.de   
Universitatsklinikum der MA Recruiting
Magdeburg, Germany, 39120
Contact: Uwe Mittler, MD    49-391-671-7210      
Johannes Gutenberg University Recruiting
Mainz, Germany, D-55101
Contact: P. Gutjahr, MD    49-6131-172-112      
Staedtisches Klinik - Kinderklinik Recruiting
Mannheim, Germany, D-68167
Contact: M. Duerken    49-621-383-2244      
Universitaets - Kinderklinik Recruiting
Marburg, Germany, 35033
Contact: H. Christiansen, MD    49-6421-286-2650      
Klinikum Minden Recruiting
Minden, Germany, D-32423
Contact: W Tilmann, MD    49-571-801-4601      
University of Muenster Recruiting
Muenster, Germany, D-48129
Contact: Contact Person    44-251-834-7742      
Dr. von Haunersches Kinderspital der Universitaet Muenchen Recruiting
Munich, Germany, D-80337
Contact: Arndt Borkhardt    49-89-5160-2842      
Krankenhaus Muenchen Schwabing Recruiting
Munich, Germany, 80804
Contact: Stefan Burdach, MD, PhD    49-89-3068-2276      
Staedtisches Krankenhaus Muenchen - Harlaching Recruiting
Munich, Germany, D-81545
Contact: Contact Person    49-89-6210-2443      
Klinikum der Universitaet Muenchen - Grosshadern Campus Recruiting
Munich, Germany, D-81377
Contact: Schulz, MD    49-89-7095-2404      
Klinikum Neubrandenburg Recruiting
Neubrandenburg, Germany, 17036
Contact: H. J. Feickert, MD, PhD    49-395-775-2901    feickerthj@dbk-nb.de   
Kinderklinik Kohlhof Recruiting
Neunkirchen, Germany, D-66539
Contact: Contact Person    49-681-3630      
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    49-941-3690      
Kinderklinik - Universitaetsklinikum Rostock Recruiting
Rostock, Germany, D-18057
Contact: Carl Friedrich Classen, MD, PD    49-381-4940    carl-friedrich.classen@med.uni-rostock.de   
Kinderklink Siegen Deutsches Rotes Kreuz Recruiting
Siegen, Germany, D-57072
Contact: Rainer Burghard, MD    49-271-23450    rainer.burghard@drk-kinderklinik.de   
Johanniter-Kinderklinik Recruiting
St. Augustin, Germany, 53757
Contact: Roswitha Dickerhoff, MD    49-2241-2490    roswitha.dickerhoft@uni-bonn.de   
Olgahospital Recruiting
Stuttgart, Germany, D-70176
Contact: Stefan Bielack, MD    49-711-992-460    st.bielack@olgahospital.de   
Krankenanstalt Mutterhaus der Borromaerinnen Recruiting
Trier, Germany, D-54290
Contact: Wolfgang Rauh, MD    49-651-947-2620      
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Germany, D-72076
Contact: Rupert Handgretinger, MD    49-7071-298-3781      
Universitaets-Kinderklinik Recruiting
Tuebingen, Germany, D-72070
Contact: Contact Person    49-707-1298-3781      
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   
Reinhard-Nieter-Krankenhaus Recruiting
Wilhelmshaven, Germany, D-26389
Contact: Liebner, MD    49-4421-891-840      
Universitaets - Kinderklinik Wuerzburg Recruiting
Wuerzburg, Germany, D-97080
Contact: P. G. Schlegel, MD    49-931-2010    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    49-41-628-384-941      
Universitaets-Kinderspital beider Basel Recruiting
Basel, Switzerland, CH-4005
Contact: Thomas Kuhne, MD    49-41-616-856-565    thomas.kuehne@ukbb.ch   
Kinderspital Luzern Recruiting
Lucerne 16, Switzerland, CH-6000
Contact: U. Caflisch, MD    49-41-412-051-111      
Ostschweizer Kinderspital Recruiting
St. Gallen, Switzerland, CH-9006
Contact: Jeanette Greiner, MD    49-41-712-437-111    jeanette.greiner@kispisg.ch   
University Children's Hospital Recruiting
Zurich, Switzerland, CH-8032
Contact: Felix Niggli, MD    49-41-1266-7111      
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: NCT00410631     History of Changes
Other Study ID Numbers: GPOH-NB2004, CDR0000517312, EU-20661
Study First Received: December 11, 2006
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
recurrent 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
Cyclophosphamide
Liposomal doxorubicin
Etoposide phosphate
Doxorubicin
Vincristine
Topotecan
Etoposide
3-Iodobenzylguanidine
Isotretinoin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on October 16, 2014