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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410631
Recruitment Status : Unknown
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : December 13, 2006
Last Update Posted : August 7, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 642 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NB2004 Trial Protocol for Risk Adapted Treatment of Children With Neuroblastoma
Study Start Date : October 2004
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Neuroblastoma

Primary Outcome Measures :
  1. Event-free survival (EFS)
  2. Locoregional EFS

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00410631

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Kinderklinik - Universitaetsklinikum Aachen Recruiting
Aachen, Germany, D-52074
Contact: R. Mertens, MD, PhD    49-241-809-222   
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      
Helios Klinikum Berlin Recruiting
Berlin, Germany, D-13125
Contact: L. Wickmann, MD    49-30-9401-2353   
Charite University Hospital - Campus Virchow Klinikum Recruiting
Berlin, Germany, D-13353
Contact: Gunter Henze    49-30-450-566-004      
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   
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   
Allgemeinen Krankenhaus Celle Kinderklinik Recruiting
Celle, Germany, 29223
Contact: Martin Kirschstein, MD    49-241-809-222   
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   
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   
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   
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   
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   
Universitaetskinderklinik - Universitaetsklinikum Freiburg Recruiting
Freiburg, Germany, D-79106
Contact: Charlotte Niemeyer, MD    49-761-270-4552   
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   
Universitaetsklinikum Halle Recruiting
Halle, Germany, D-06097
Contact: Dieter Koerholz, MD    49-345-557-2911      
Krankenhaus St. Elisabeth und St. Barbara Recruiting
Halle, Germany, D-06110
Contact: G. Guenther, MD    49-345-213-4514      
University Medical Center Hamburg - Eppendorf Recruiting
Hamburg, Germany, D-20246
Contact: Rudolf Erttmann, MD    49-40-428-034-270   
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   
Universitaets-Kinderklinik Heidelberg Recruiting
Heidelberg, Germany, D-69120
Contact: Andreas E. Kulozik, MD, PhD    49-6221-562-311   
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   
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   
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   
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      
Krankenhaus Muenchen Schwabing Recruiting
Munich, Germany, 80804
Contact: Stefan Burdach, MD, PhD    49-89-3068-2276      
Dr. von Haunersches Kinderspital der Universitaet Muenchen Recruiting
Munich, Germany, D-80337
Contact: Arndt Borkhardt    49-89-5160-2842      
Klinikum der Universitaet Muenchen - Grosshadern Campus Recruiting
Munich, Germany, D-81377
Contact: Schulz, MD    49-89-7095-2404      
Staedtisches Krankenhaus Muenchen - Harlaching Recruiting
Munich, Germany, D-81545
Contact: Contact Person    49-89-6210-2443      
Klinikum Neubrandenburg Recruiting
Neubrandenburg, Germany, 17036
Contact: H. J. Feickert, MD, PhD    49-395-775-2901   
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   
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   
Kinderklink Siegen Deutsches Rotes Kreuz Recruiting
Siegen, Germany, D-57072
Contact: Rainer Burghard, MD    49-271-23450   
Johanniter-Kinderklinik Recruiting
St. Augustin, Germany, 53757
Contact: Roswitha Dickerhoff, MD    49-2241-2490   
Olgahospital Recruiting
Stuttgart, Germany, D-70176
Contact: Stefan Bielack, MD    49-711-992-460   
Krankenanstalt Mutterhaus der Borromaerinnen Recruiting
Trier, Germany, D-54290
Contact: Wolfgang Rauh, MD    49-651-947-2620      
Universitaets-Kinderklinik Recruiting
Tuebingen, Germany, D-72070
Contact: Contact Person    49-707-1298-3781      
Universitaetsklinikum Tuebingen Recruiting
Tuebingen, Germany, D-72076
Contact: Rupert Handgretinger, MD    49-7071-298-3781      
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm Recruiting
Ulm, Germany, D-89075
Contact: Klaus M. Debatin, MD    49-731-5002-7790   
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   
Helios Kliniken Wuppertal University Hospital Recruiting
Wuppertal, Germany, D-42283
Contact: K. Sinha, MD    49-202-896-2441      
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   
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   
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
Study Chair: Frank Berthold, MD Children's Hospital Medical Center, Cincinnati

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00410631     History of Changes
Other Study ID Numbers: GPOH-NB2004
CDR0000517312 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: December 13, 2006    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: January 2008

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:
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Liposomal doxorubicin
Etoposide phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action