Combination Chemotherapy Followed by Stem Cell Transplant and Isotretinoin in Treating Young Patients With High-Risk Neuroblastoma
NCT ID: NCT00526318
Last Updated: 2015-07-16
Study Results
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Basic Information
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UNKNOWN
NA
360 participants
INTERVENTIONAL
2007-01-31
Brief Summary
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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.
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Detailed Description
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Primary
* Compare the event-free survival of pediatric patients with high-risk neuroblastoma treated with standard induction chemotherapy vs topotecan hydrochloride-containing induction chemotherapy followed by myeloablative autologous stem cell transplantation and consolidation therapy with isotretinoin.
Secondary
* Compare the overall survival of patients treated with these regimens.
* Compare early response (complete response, very good partial response, partial response, mixed response, stable disease, and progression/relapse) after 2 courses of standard vs experimental induction chemotherapy (or after 60 days if the second course is not yet finished).
* Compare response to standard vs experimental induction chemotherapy before autologous stem cell transplantation (or after 280 days if induction chemotherapy is not yet finished).
* Compare the toxicity of standard vs experimental induction chemotherapy during courses 1 and 2 and the frequency of ≥ grade 3 toxicity during the last 6 courses of induction chemotherapy.
* Compare the extent of initial surgery and best surgery (biopsy vs incomplete resection vs macroscopic complete resection) and the frequency of complications related to surgery (e.g., nephrectomy, bleeding, infection, or intestinal obstruction).
* Compare the acute and long-term side effects of external-beam radiotherapy.
* Correlate the activity of MIBG and whole-body radiation dose.
* Collect and store tumor material in the tumor bank for future evaluation of other molecular markers (MYCN and status of chromosome 1p and 11q) and prognostic significant gene signatures.
OUTLINE: This is a multicenter study. Patients are stratified according to disease stage, lactate dehydrogenase (LDH) status, MYCN status, and age at diagnosis (stage 4 disease; LDH not elevated; any MYCN status; age at diagnosis 1-21 years vs stage 4 disease; LDH elevated; any MYCN status; age at diagnosis ≥ 1 but \< 2 years vs stage 4 disease; LDH elevated; any MYCN status; age at diagnosis 2-21 years vs localized disease; MYCN amplification; age at diagnosis ≥ 6 months)
* Induction chemotherapy: Patients are randomized to 1 of 2 induction chemotherapy arms.
* Arm I (standard): Patients receive N5 chemotherapy comprising cisplatin IV continuously over 96 hours and etoposide phosphate IV continuously over 96 hours on days 1-4 and vindesine IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 9 and continuing until blood counts recover. Patients then receive N6 chemotherapy comprising vincristine IV over 1 hour on days 1 and 8, dacarbazine IV over 1 hour on days 1-5, ifosfamide IV continuously over 120 hours on days 1-5, and doxorubicin hydrochloride IV over 4 hours on days 6 and 7. Patients also receive G-CSF SC once daily beginning on day 10 and continuing until blood counts recover. Treatment with N5 and N6 chemotherapy alternates every 21 days for 6 courses (N5 chemotherapy is given in courses 1, 3, and 5 and N6 chemotherapy is given in courses 2, 4, and 6).
* Arm II (experimental): Patients receive N8 chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-7, topotecan hydrochloride IV continuously over 168 hours on days 1-7, and etoposide phosphate IV over 1 hour on days 8-10. Patients also receive G-CSF SC once daily beginning on day 12 and continuing until blood counts recover. Treatment with N8 chemotherapy repeats every 21 days for 2 courses. Patients then receive N5 chemotherapy alternating with N6 chemotherapy as in arm I.
* Surgery: Patients may undergo secondary surgery after completion of 4 or 6 courses of induction chemotherapy but prior to radiotherapy.
* Radiotherapy (131I-MIBG therapy and external-beam radiotherapy \[EBRT\]): Patients with active residual primary tumor after the completion of induction chemotherapy undergo \^131I-MIBG therapy\* prior to autologous stem cell transplantation (ASCT) and EBRT after ASCT.
NOTE: \*Patients with MIBG negative neuroblastoma at initial diagnosis will only receive EBRT.
* Myeloablative ASCT: Patients receive melphalan IV over 30 minutes on days -8 to -5, etoposide phosphate IV over 4 hours on day -4, and carboplatin IV over 1 hour on days -4 to -2. Patients undergo reinfusion of CD34+ stem cells on day 0. Patients also receive G-CSF SC or IV over 4 hours once daily beginning on day 2 and continuing until blood counts recover.
* Consolidation therapy (isotretinoin)\*: Beginning 30 days after ASCT, patients receive oral isotretinoin once daily on days 1-14. Treatment repeats every 28 days for up to 6 courses. Beginning 3 months later, patients receive an additional 3 courses of isotretinoin.
NOTE: \*Isotretinoin must not be given concurrently with radiotherapy
After completion of study treatment, patients are followed every 6 weeks for 1 year, every 3 months for 4 years, and then every 6 months thereafter.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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filgrastim
carboplatin
cisplatin
cyclophosphamide
dacarbazine
doxorubicin hydrochloride
etoposide phosphate
ifosfamide
isotretinoin
melphalan
topotecan hydrochloride
vincristine sulfate
vindesine
autologous hematopoietic stem cell transplantation
iobenguane I 131
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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German Society for Pediatric Oncology and Hematology GPOH gGmbH
OTHER
Principal Investigators
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Frank Berthold, MD
Role: STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Locations
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Kinderklinik - Universitaetsklinikum Aachen
Aachen, , Germany
Klinikum Augsburg
Augsburg, , Germany
Klinikum Bayreuth
Bayreuth, , Germany
Helios Klinikum Berlin
Berlin, , Germany
Charite University Hospital - Campus Virchow Klinikum
Berlin, , Germany
Evangelisches Krankenhauus Bielfeld
Biefeld, , Germany
Kinderklinik der Universitaet Bonn
Bonn, , Germany
Staedtisches Klinikum - Howedestrase
Braunschweig, , Germany
Klinikum Bremen-Mitte
Bremen, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Klinikum Coburg
Coburg, , Germany
Children's Hospital
Cologne, , Germany
Carl - Thiem - Klinkum Cottbus
Cottbus, , Germany
Vestische Kinderklinik
Datteln, , Germany
Klinikum Lippe - Detmold
Detmold, , Germany
Klinikum Dortmund
Dortmund, , Germany
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Klinikum Duisburg
Duisburg, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Helios Klinikum Erfurt
Erfurt, , Germany
Universitaets - Kinderklinik
Erlangen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , Germany
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Kinderklinik
Giessen, , Germany
Universitaetsklinikum Goettingen
Göttingen, , Germany
Universitats - Kinderklinik
Greiswald, , Germany
Universitaetsklinikum Halle
Halle, , Germany
Krankenhaus St. Elisabeth und St. Barbara
Halle, , Germany
University Medical Center Hamburg - Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaets-Kinderklinik Heidelberg
Heidelberg, , Germany
Gemeinschaftskrankenhaus
Herdecke, , Germany
Universitaetsklinikum des Saarlandes
Homburg, , Germany
Universitaets - Kinderklinik
Jena, , Germany
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, , Germany
Klinikum Kassel
Kassel, , Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, , Germany
Klinikum Kemperhof Koblenz
Koblenz, , Germany
Klinikum Krefeld GmbH
Krefeld, , Germany
St. Annastift Krankenhaus
Ludwigshafen, , Germany
Universitaets - Kinderklinik - Luebeck
Lübeck, , Germany
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
Magdeburg, , Germany
Johannes Gutenberg University
Mainz, , Germany
Staedtisches Klinik - Kinderklinik
Mannheim, , Germany
Universitaetsklinikum Giessen und Marburg GmbH - Marburg
Marburg, , Germany
Klinikum Minden
Minden, , Germany
Krankenhaus Muenchen Schwabing
Munich, , Germany
Dr. von Haunersches Kinderspital der Universitaet Muenchen
Munich, , Germany
Klinik und Poliklinik fuer Kinder und Jugendmedizin - Universitaetsklinikum Muenster
Münster, , Germany
Klinikum Neubrandenburg
Neubrandenburg, , Germany
Cnopf'sche Kinderklinik
Nuremberg, , Germany
Klinikum Oldenburg
Oldenburg, , Germany
Klinik St. Hedwig-Kinderklinik
Regensburg, , Germany
Kinderklinik - Universitaetsklinikum Rostock
Rostock, , Germany
Johanniter-Kinderklinik
Sankt Augustin, , Germany
Kinderklink Siegen Deutsches Rotes Kreuz
Siegen, , Germany
Olgahospital
Stuttgart, , Germany
Krankenanstalt Mutterhaus der Borromaerinnen
Trier, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, , Germany
Helios Kliniken Wuppertal University Hospital
Wuppertal, , Germany
Universitaets - Kinderklinik Wuerzburg
Würzburg, , Germany
Kantonsspital Aarau
Aarau, , Switzerland
Universitaets-Kinderspital beider Basel
Basel, , Switzerland
Kinderspital Luzern
Lucerne, , Switzerland
Ostschweizer Kinderspital
Sankt Gallen, , Switzerland
University Children's Hospital
Zurich, , Switzerland
Countries
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Facility Contacts
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Astrid Gnekow
Role: primary
T. Rupprecht
Role: primary
Lothar Schweigerer, MD
Role: primary
Gunter Henze
Role: primary
N. Jorch, MD
Role: primary
Krause, MD
Role: primary
Roland Frank, MD
Role: primary
D Mobius, MD
Role: primary
Klaus Wesseler, MD
Role: primary
Ruef, MD
Role: primary
Arndt Borkhardt
Role: primary
W. Holter, MD
Role: primary
Bernhard Kremens, MD
Role: primary
Alfred Reiter, MD
Role: primary
M. Lakomek, MD
Role: primary
Dieter Koerholz, MD
Role: primary
G. Guenther, MD
Role: primary
Norbert Graf
Role: primary
Felix Zintl, MD
Role: primary
A. Leipold
Role: primary
Martina Rodehueser, MD
Role: primary
M. Rister, MD
Role: primary
S. Volpel, MD
Role: primary
Barbara Selle, MD
Role: primary
P. Vorwerk, MD
Role: primary
P. Gutjahr, MD
Role: primary
M. Duerken
Role: primary
H. Christiansen, MD
Role: primary
Stefan Burdach, MD, PhD
Role: primary
Irene Schmid, MD
Role: primary
W. Scheurlen
Role: primary
Ove Peters
Role: primary
Wolfgang Rauh, MD
Role: primary
Rupert Handgretinger, MD
Role: primary
K. Sinha, MD
Role: primary
R. Angst
Role: primary
U. Caflisch, MD
Role: primary
Felix Niggli, MD
Role: primary
Other Identifiers
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CDR0000564820
Identifier Type: REGISTRY
Identifier Source: secondary_id
UNI-KOELN-161
Identifier Type: -
Identifier Source: secondary_id
EU-20661
Identifier Type: -
Identifier Source: secondary_id
GPOH-NB2004-HR
Identifier Type: -
Identifier Source: org_study_id
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