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

NCT00526318 | Unknown

• 4 other identifiers: GPOH-NB2004-HRCDR0000564820UNI-KOELN-161EU-20661
• Study Type: interventional
• Target: 360
• Locations: 2 countries
• Sites: 68

Brief Summary

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.

Conditions

Neuroblastoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS)

Secondary Outcomes (9)

• Overall survival (OS)

• Impact of well established clinical and molecular risk factors on EFS and OS

• Early response, measured after 2 courses of induction chemotherapy

• Response to induction therapy, measured before autologous stem cell transplantation

• Toxicity during the first 2 courses and the last 6 courses of induction chemotherapy

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

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 according to any of the following criteria: * Histological diagnosis from tumor tissue * Presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine * High-risk disease, meeting 1 of the following criteria: * Stage 4 disease, regardless of the MYCN status (1-21 years of age) * Stage 1-3 or 4S disease with MYCN amplification (6 months -21 years of age) PATIENT CHARACTERISTICS: * Not pregnant or nursing * Fertile patients must use effective contraception (hormonal contraception or intra-uterine device \[IUD\]) PRIOR CONCURRENT THERAPY: * No concurrent participation in another clinical trial that would preclude the interventions or outcome assessment of this clinical trial * 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 (68)

Kinderklinik - Universitaetsklinikum Aachen

Aachen, D-52074, Germany

RECRUITING

Klinikum Augsburg

Augsburg, DOH-86156, Germany

RECRUITING

Klinikum Bayreuth

Bayreuth, D-95445, Germany

RECRUITING

Helios Klinikum Berlin

Berlin, 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

Klinikum Chemnitz gGmbH

Chemnitz, D-09116, Germany

RECRUITING

Klinikum Coburg

Coburg, 96450, 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

Universitaetsklinikum 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

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

RECRUITING

Universitaets-Kinderklinik Heidelberg

Heidelberg, D-69120, Germany

RECRUITING

Gemeinschaftskrankenhaus

Herdecke, 58313, Germany

RECRUITING

Universitaetsklinikum des Saarlandes

Homburg, 66421, Germany

RECRUITING

Universitaets - Kinderklinik

Jena, D-07745, Germany

RECRUITING

Staedtisches Klinikum Karlsruhe gGmbH

Karlsruhe, 76133, 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

Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

Magdeburg, D-39120, Germany

RECRUITING

Johannes Gutenberg University

Mainz, D-55101, Germany

RECRUITING

Staedtisches Klinik - Kinderklinik

Mannheim, D-68167, Germany

RECRUITING

Universitaetsklinikum Giessen und Marburg GmbH - Marburg

Marburg, D-35043, 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

Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster

Münster, D-48149, Germany

RECRUITING

Klinikum Neubrandenburg

Neubrandenburg, 17036, 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

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

RECRUITING

Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

Ulm, D-89075, 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

MeSH Terms

Conditions

Neuroblastoma

Interventions

Filgrastim; Carboplatin; Cisplatin; Cyclophosphamide; Dacarbazine; Doxorubicin; etoposide phosphate; Ifosfamide; Isotretinoin; Melphalan; Topotecan; Vincristine; Vindesine; 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; Guanidines; Amidines; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Iodinated; Therapeutics

Study Officials

• Frank Berthold, MD

  Children's Hospital Medical Center, Cincinnati

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 5, 2007
• First Posted: September 10, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2016
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

DE (63); CH (5)