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. The completion date has passed and the status has not been verified in more than two years.
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)
  • Locoregional EFS

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

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   (Child, Adult)
Sexes Eligible for Study:   All
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
Aachen, Germany, D-52074
Klinikum Augsburg
Augsburg, Germany, DOH-86156
Klinikum am Bamberg
Bamberg, Germany, 96049
Klinikum Bayreuth
Bayreuth, Germany, D-95445
Helios Klinikum Berlin
Berlin, Germany, D-13125
Charite University Hospital - Campus Virchow Klinikum
Berlin, Germany, D-13353
Evangelisches Krankenhauus Bielfeld
Biefeld, Germany, 33617
Kinderklinik der Universitaet Bonn
Bonn, Germany, D-53113
Staedtisches Klinikum - Howedestrase
Braunschweig, Germany, 38118
Klinikum Bremen-Mitte
Bremen, Germany, D-28205
Allgemeinen Krankenhaus Celle Kinderklinik
Celle, Germany, 29223
Klinikum Chemnitz gGmbH
Chemnitz, Germany, D-09116
Klinikum Coburg
Coburg, Germany, 96450
Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl
Cologne, Germany, D-50735
Children's Hospital
Cologne, Germany, D-50924
Carl - Thiem - Klinkum Cottbus
Cottbus, Germany, D-03048
Vestische Kinderklinik
Datteln, Germany, 45704
Klinikum Lippe - Detmold
Detmold, Germany, D-32756
Klinikum Dortmund
Dortmund, Germany, D-44137
Universitatsklinikum Carl Gustav Carus
Dresden, Germany, D-01307
Universitaets - Frauenklinik, Duesseldorf
Duesseldorf, Germany, D-40225
Klinikum Duisburg
Duisburg, Germany, D-47055
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Universitaets - Kinderklinik
Erlangen, Germany, 91054
Universitaetsklinikum Essen
Essen, Germany, D-45147
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg, Germany, D-79106
Kinderklinik
Giessen, Germany, D-35385
Universitaetsklinikum Goettingen
Goettingen, Germany, D-37075
Universitats - Kinderklinik
Greiswald, Germany, 17487
Universitaetsklinikum Halle
Halle, Germany, D-06097
Krankenhaus St. Elisabeth und St. Barbara
Halle, Germany, D-06110
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
Kinderkrankenhaus auf der Bult
Hannover, Germany, 30173
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Universitaets-Kinderklinik Heidelberg
Heidelberg, Germany, D-69120
SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
Heilbronn, Germany, D-74064
Gemeinschaftskrankenhaus
Herdecke, Germany, 58313
Universitaetsklinikum des Saarlandes
Homburg, Germany, 66421
Universitaets - Kinderklinik
Jena, Germany, D-07440
Universitaets - Kinderklinik
Jena, Germany, D-07745
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany, 76133
Kinderkrankenhaus Park Schoenfeld
Kassel, Germany, D-34121
Klinikum Kassel
Kassel, Germany, D-34125
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24105
Klinikum Kemperhof Koblenz
Koblenz, Germany, D-56065
Klinikum Krefeld GmbH
Krefeld, Germany, D-47805
St. Annastift Krankenhaus
Ludwigshafen, Germany, 67065
Universitaets - Kinderklinik - Luebeck
Luebeck, Germany, D-23538
Universitatsklinikum der MA
Magdeburg, Germany, 39120
Johannes Gutenberg University
Mainz, Germany, D-55101
Staedtisches Klinik - Kinderklinik
Mannheim, Germany, D-68167
Universitaets - Kinderklinik
Marburg, Germany, 35033
Klinikum Minden
Minden, Germany, D-32423
University of Muenster
Muenster, Germany, D-48129
Krankenhaus Muenchen Schwabing
Munich, Germany, 80804
Dr. von Haunersches Kinderspital der Universitaet Muenchen
Munich, Germany, D-80337
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, Germany, D-81377
Staedtisches Krankenhaus Muenchen - Harlaching
Munich, Germany, D-81545
Klinikum Neubrandenburg
Neubrandenburg, Germany, 17036
Kinderklinik Kohlhof
Neunkirchen, Germany, D-66539
Cnopf'sche Kinderklinik
Nuremberg, Germany, 90419
Klinikum Oldenburg
Oldenburg, Germany, 26133
Klinik St. Hedwig-Kinderklinik
Regensburg, Germany, 93049
Kinderklinik - Universitaetsklinikum Rostock
Rostock, Germany, D-18057
Kinderklink Siegen Deutsches Rotes Kreuz
Siegen, Germany, D-57072
Johanniter-Kinderklinik
St. Augustin, Germany, 53757
Olgahospital
Stuttgart, Germany, D-70176
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, Germany, D-54290
Universitaets-Kinderklinik
Tuebingen, Germany, D-72070
Universitaetsklinikum Tuebingen
Tuebingen, Germany, D-72076
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, Germany, D-89075
Reinhard-Nieter-Krankenhaus
Wilhelmshaven, Germany, D-26389
Universitaets - Kinderklinik Wuerzburg
Wuerzburg, Germany, D-97080
Helios Kliniken Wuppertal University Hospital
Wuppertal, Germany, D-42283
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Universitaets-Kinderspital beider Basel
Basel, Switzerland, CH-4005
Kinderspital Luzern
Lucerne 16, Switzerland, CH-6000
Ostschweizer Kinderspital
St. Gallen, Switzerland, CH-9006
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

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

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
Melphalan
Ifosfamide
Liposomal doxorubicin
Etoposide phosphate
Carboplatin
Doxorubicin
Vincristine
Etoposide
Topotecan
3-Iodobenzylguanidine
Vindesine
Isotretinoin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on January 19, 2017