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

NCT00410631 | Unknown Phase 3

• 3 other identifiers: GPOH-NB2004CDR0000517312EU-20661
• Study Type: interventional
• Target: 642
• Locations: 2 countries
• Sites: 80

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.

Conditions

Neuroblastoma

Keywords

localized resectable neuroblastoma; localized unresectable neuroblastoma; regional neuroblastoma; stage 4S neuroblastoma; disseminated neuroblastoma; recurrent neuroblastoma

Outcome Measures

Primary Outcomes (2)

• Event-free survival (EFS)

• Locoregional EFS

Secondary Outcomes (21)

• 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)

Interventions

filgrastim BIOLOGICAL

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 DRUG

autologous hematopoietic stem cell transplantation PROCEDURE

conventional surgery PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

iobenguane I 131 RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• German Society for Pediatric Oncology and Hematology GPOH gGmbH: lead

Study Sites (80)

Kinderklinik - Universitaetsklinikum Aachen

Aachen, D-52074, Germany

RECRUITING

Klinikum Augsburg

Augsburg, DOH-86156, Germany

RECRUITING

Klinikum am Bamberg

Bamberg, 96049, Germany

RECRUITING

Klinikum Bayreuth

Bayreuth, D-95445, Germany

RECRUITING

Helios Klinikum Berlin

Berlin, D-13125, Germany

RECRUITING

Charite University Hospital - Campus Virchow Klinikum

Berlin, D-13353, Germany

RECRUITING

Evangelisches Krankenhauus Bielfeld

Biefeld, 33617, Germany

RECRUITING

Kinderklinik der Universitaet Bonn

Bonn, D-53113, Germany

RECRUITING

Staedtisches Klinikum - Howedestrase

Braunschweig, 38118, Germany

RECRUITING

Klinikum Bremen-Mitte

Bremen, D-28205, Germany

RECRUITING

Allgemeinen Krankenhaus Celle Kinderklinik

Celle, 29223, Germany

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, D-09116, Germany

RECRUITING

Klinikum Coburg

Coburg, 96450, Germany

RECRUITING

Kliniken der Stadt Koeln gGmbH - Kinderkrankenhaus Riehl

Cologne, D-50735, Germany

RECRUITING

Children's Hospital

Cologne, D-50924, Germany

RECRUITING

Carl - Thiem - Klinkum Cottbus

Cottbus, D-03048, Germany

RECRUITING

Vestische Kinderklinik

Datteln, 45704, Germany

RECRUITING

Klinikum Lippe - Detmold

Detmold, D-32756, Germany

RECRUITING

Klinikum Dortmund

Dortmund, D-44137, Germany

RECRUITING

Universitatsklinikum Carl Gustav Carus

Dresden, D-01307, Germany

RECRUITING

Klinikum Duisburg

Duisburg, D-47055, Germany

RECRUITING

Universitaets - Frauenklinik, Duesseldorf

Düsseldorf, D-40225, Germany

RECRUITING

Helios Klinikum Erfurt

Erfurt, 99089, Germany

RECRUITING

Universitaets - Kinderklinik

Erlangen, 91054, Germany

RECRUITING

Universitaetsklinikum Essen

Essen, D-45147, Germany

RECRUITING

Klinikum der J.W. Goethe Universitaet

Frankfurt, D-60590, Germany

RECRUITING

Universitaetskinderklinik - Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

RECRUITING

Kinderklinik

Giessen, D-35385, Germany

RECRUITING

Universitaetsklinikum Goettingen

Göttingen, D-37075, Germany

RECRUITING

Universitats - Kinderklinik

Greiswald, 17487, Germany

RECRUITING

Universitaetsklinikum Halle

Halle, D-06097, Germany

RECRUITING

Krankenhaus St. Elisabeth und St. Barbara

Halle, D-06110, Germany

RECRUITING

University Medical Center Hamburg - Eppendorf

Hamburg, D-20246, Germany

RECRUITING

Kinderkrankenhaus auf der Bult

Hanover, 30173, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

RECRUITING

Universitaets-Kinderklinik Heidelberg

Heidelberg, D-69120, Germany

RECRUITING

SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen

Heilbronn, D-74064, Germany

RECRUITING

Gemeinschaftskrankenhaus

Herdecke, 58313, Germany

RECRUITING

Universitaetsklinikum des Saarlandes

Homburg, 66421, Germany

RECRUITING

Universitaets - Kinderklinik

Jena, D-07440, Germany

RECRUITING

Universitaets - Kinderklinik

Jena, D-07745, Germany

RECRUITING

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, Germany

RECRUITING

Kinderkrankenhaus Park Schoenfeld

Kassel, D-34121, Germany

RECRUITING

Klinikum Kassel

Kassel, D-34125, Germany

RECRUITING

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

RECRUITING

Klinikum Kemperhof Koblenz

Koblenz, D-56065, Germany

RECRUITING

Klinikum Krefeld GmbH

Krefeld, D-47805, Germany

RECRUITING

St. Annastift Krankenhaus

Ludwigshafen, 67065, Germany

RECRUITING

Universitaets - Kinderklinik - Luebeck

Lübeck, D-23538, Germany

RECRUITING

Universitatsklinikum der MA

Magdeburg, 39120, Germany

RECRUITING

Johannes Gutenberg University

Mainz, D-55101, Germany

RECRUITING

Staedtisches Klinik - Kinderklinik

Mannheim, D-68167, Germany

RECRUITING

Universitaets - Kinderklinik

Marburg, 35033, Germany

RECRUITING

Klinikum Minden

Minden, D-32423, Germany

RECRUITING

Krankenhaus Muenchen Schwabing

Munich, 80804, Germany

RECRUITING

Dr. von Haunersches Kinderspital der Universitaet Muenchen

Munich, D-80337, Germany

RECRUITING

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

RECRUITING

Staedtisches Krankenhaus Muenchen - Harlaching

Munich, D-81545, Germany

RECRUITING

University of Muenster

Münster, D-48129, Germany

RECRUITING

Klinikum Neubrandenburg

Neubrandenburg, 17036, Germany

RECRUITING

Kinderklinik Kohlhof

Neunkirchen, D-66539, Germany

RECRUITING

Cnopf'sche Kinderklinik

Nuremberg, 90419, Germany

RECRUITING

Klinikum Oldenburg

Oldenburg, 26133, Germany

RECRUITING

Klinik St. Hedwig-Kinderklinik

Regensburg, 93049, Germany

RECRUITING

Kinderklinik - Universitaetsklinikum Rostock

Rostock, D-18057, Germany

RECRUITING

Johanniter-Kinderklinik

Sankt Augustin, 53757, Germany

RECRUITING

Kinderklink Siegen Deutsches Rotes Kreuz

Siegen, D-57072, Germany

RECRUITING

Olgahospital

Stuttgart, D-70176, Germany

RECRUITING

Krankenanstalt Mutterhaus der Borromaerinnen

Trier, D-54290, Germany

RECRUITING

Universitaets-Kinderklinik

Tübingen, D-72070, Germany

RECRUITING

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

RECRUITING

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89075, Germany

RECRUITING

Reinhard-Nieter-Krankenhaus

Wilhelmshaven, D-26389, Germany

RECRUITING

Helios Kliniken Wuppertal University Hospital

Wuppertal, D-42283, Germany

RECRUITING

Universitaets - Kinderklinik Wuerzburg

Würzburg, D-97080, Germany

RECRUITING

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

RECRUITING

Universitaets-Kinderspital beider Basel

Basel, CH-4005, Switzerland

RECRUITING

Kinderspital Luzern

Lucerne, CH-6000, Switzerland

RECRUITING

Ostschweizer Kinderspital

Sankt Gallen, CH-9006, Switzerland

RECRUITING

University Children's Hospital

Zurich, CH-8032, Switzerland

RECRUITING

Related Publications (1)

• Decarolis B, Simon T, Krug B, Leuschner I, Vokuhl C, Kaatsch P, von Schweinitz D, Klingebiel T, Mueller I, Schweigerer L, Berthold F, Hero B. Treatment and outcome of Ganglioneuroma and Ganglioneuroblastoma intermixed. BMC Cancer. 2016 Jul 27;16:542. doi: 10.1186/s12885-016-2513-9.

  PMID: 27465021 DERIVED

MeSH Terms

Conditions

Neuroblastoma

Interventions

Filgrastim; Carboplatin; Cisplatin; Cyclophosphamide; Dacarbazine; Doxorubicin; etoposide phosphate; Ifosfamide; Isotretinoin; Melphalan; Topotecan; Vincristine; Vindesine; Peripheral Blood Stem Cell Transplantation; 3-Iodobenzylguanidine; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Oxazines; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Terpenes; Pigments, Biological; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Camptothecin; Alkaloids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Guanidines; Amidines; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Iodinated

Study Officials

• Frank Berthold, MD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 13, 2006
• Study Start: October 1, 2004
• Primary Completion: December 1, 2010
• Last Updated: August 7, 2013

Record last verified: 2008-01

Locations

DE (75); CH (5)