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| Sponsor: | Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017225 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells. Combining these therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and radiation therapy with or without peripheral stem cell transplantation in treating patients who have neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: melphalan Drug: tretinoin Drug: vincristine sulfate Drug: vindesine Procedure: autologous bone marrow transplantation Procedure: conventional surgery Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Neuroblastoma Study Phase II Study of Various Therapies in Patients With Neuroblastoma |
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Observation stratum:
Standard-risk stratum:
High-risk stratum:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| Germany | |
| Altonaer Kinderkrankenhaus | |
| Hamburg, Germany, 22763 | |
| Caritaskrankenhaus | |
| Bad Mergentheim, Germany, 97980 | |
| Carl - Thiem - Klinkum Cottbus | |
| Cottbus, Germany, D-03048 | |
| Charite - Campus Virchow Klinikum | |
| Berlin, Germany, D-13353 | |
| Cnopfche Kinderklinik | |
| Nuernberg, Germany, 90419 | |
| Deutsches Rotes Kreuz | |
| Siegen, Germany, 57072 | |
| Diakone - Krankenhaus | |
| Schwabisch Hall, Germany, 74523 | |
| Evangelische Krankenhaus Hamm | |
| Hamm, Germany, DOH-59063 | |
| Gemeinschaftskrankenhaus | |
| Herdecke, Germany, 58313 | |
| Helios Klinikum Berlin | |
| Berlin, Germany, 13122 | |
| Helios Klinikum Erfurt GmbH | |
| Erfurt, Germany, 99012 | |
| Helios Klinikum Wuppertal | |
| Wuppertal, Germany, D-42283 | |
| Johannes Gutenberg University | |
| Mainz, Germany, D-55131 | |
| Johanniter-Kinderklinik | |
| St. Augustin, Germany, 53757 | |
| Kinderklinik - Universitaetsklinikum Rostock | |
| Rostock, Germany, D-18057 | |
| Kinderklinik Kohlhof | |
| Neunkirchen, Germany, 66539 | |
| Kinderklinik d. TU / Schwabing | |
| Munich, Germany, 80804 | |
| Kinderklinik der Universitaet-Bonn | |
| Bonn, Germany, DOH-53113 | |
| Kinderklinik | |
| Munich, Germany, DOH-80337 | |
| Kinderklinik | |
| Giessen, Germany, D-35385 | |
| Kinderkrankenhaus Josefinum | |
| Augsburg, Germany, 86154 | |
| Kinderkrankenhaus auf der Bult | |
| Hannover, Germany, 30173 | |
| Kinderkrankenhaus | |
| Kassel, Germany, 34121 | |
| Praxis am Evangelischen Krankenhaus Bethanien | |
| Iserlohn, Germany, D-58644 | |
| Klinik Konstanz | |
| Konstanz, Germany, 78461 | |
| Klinik und Poliklinik fuer Kinderheilkunde - Universitaetsklinikum Muenster | |
| Muenster, Germany, D-48149 | |
| Klinikum Bayreuth | |
| Bayreuth, Germany, 95445 | |
| Klinikum Chemnitz GMBH | |
| Chemnitz, Germany, D-09116 | |
| Klinikum Coburg | |
| Coburg, Germany, 96450 | |
| Klinikum Kassel | |
| Kassel, Germany, D-34125 | |
| Klinikum Krefeld GmbH | |
| Krefeld, Germany, D-47805 | |
| Klinikum Lippe - Detmold | |
| Detmold, Germany, 32756 | |
| Klinikum Minden | |
| Minden, Germany, D-32423 | |
| Klinikum Oldenburg | |
| Oldenburg, Germany, 26133 | |
| Klinikum Schwerin | |
| Schwerin, Germany, D-19049 | |
| Klinikum der J.W. Goethe Universitaet | |
| Frankfurt, Germany, D-60590 | |
| Krankenanstalten Gilead | |
| Biefeld, Germany, 33617 | |
| Krankenhaus D Barmherzigen Brueder | |
| Regensburg, Germany, 93049 | |
| Kreiskrankenhaus Gummersbach GMBH | |
| Gummersbach, Germany, D-51643 | |
| Leopoldina - Krankenhaus | |
| Schwienfurt, Germany, 97422 | |
| Marien Hospital | |
| Homburg, Germany, D-66421 | |
| Martin Luther Universitaet | |
| Halle, Germany, 06097 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, D-30625 | |
| Medizinische Universitaetsklinik I | |
| Cologne, Germany, D-50924 | |
| Mutterhaus der Borromaerinnen | |
| Trier, Germany, D-54290 | |
| Olgahospital | |
| Stuttgart, Germany, DOH-70176 | |
| Kindershospital | |
| Osnabruck, Germany, D-49082 | |
| Reinhard - Nieter - Krankenhaus | |
| Wilhelmshaven, Germany, 26389 | |
| Saarbrucker Winterbergkliniken | |
| Saarbrucken, Germany, 66119 | |
| St. Annastift Krankenhaus | |
| Ludwigshafen, Germany, 67065 | |
| St. Barbara Krankenhaus | |
| Halle, Germany, 06003 | |
| St. Marien Hospital | |
| Vechta, Germany, D-49377 | |
| Stadt Klinikum - Howedestrase | |
| Braunschweig, Germany, 38118 | |
| Stadt. KH Dresden - Neustadt | |
| Dresden, Germany, 01229 | |
| Stadt. Kinderklinik | |
| Karlsruhe, Germany, 76131 | |
| Stadt. Kinderklinik | |
| Gelsenkirchen, Germany, 45892 | |
| Stadt. Klinik - Kinderklinik | |
| Mannheim, Germany, 68167 | |
| Stadt. Kliniken | |
| Dortmund, Germany, 44123 | |
| Stadt. Krankenhaus Kemperhof | |
| Koblenz, Germany, 56065 | |
| Universitaets - Kinderpoliklinik | |
| Munich, Germany, 80336 | |
| Staedtische Krankenhaus Kiel | |
| Kiel, Germany, 23116 | |
| Staedtisches Kinderkrankenhaus | |
| Koln - Riehl, Germany, D-50735 | |
| Staedtisches Krankenhaus Muenchen - Harlaching | |
| Munich, Germany, D-81545 | |
| Universitaet Ulm | |
| Ulm, Germany, D-89075 | |
| Universitaets - Kinderklinik - Luebeck | |
| Lubeck, Germany, 23538 | |
| Universitaets - Kinderklinik Wuerzburg | |
| Wuerzburg, Germany, D-97080 | |
| Universitaets - Kinderklinik | |
| Jena, Germany, D-07745 | |
| Universitaets - Kinderklinik | |
| Erlangen, Germany, D-91054 | |
| Universitaets - Kinderklinik | |
| Leipzig, Germany, 04317 | |
| Universitaets - Kinderklinik | |
| Marburg, Germany, 35033 | |
| Staedtische Klinikum-Kinderklinik | |
| Rosenheim, Germany, 83022 | |
| Universitaets Klinik fuer Kinderchirurgie | |
| Leipzig, Germany, D-04317 | |
| Universitaets-Kinderklinik Heidelberg | |
| Heidelberg, Germany, D-69120 | |
| Universitaets-Krankenhaus Eppendorf | |
| Hamburg, Germany, D-20246 | |
| Universitaetskinderklinik - Universitaetsklinikum Freiburg | |
| Freiburg, Germany, 79106 | |
| Universitaetsklinik Duesseldorf | |
| Duesseldorf, Germany, D-40225 | |
| Universitaetsklinikum Essen | |
| Essen, Germany, D-45122 | |
| Universitatsklinikum der MA | |
| Magdeburg, Germany, 39112 | |
| Universitaetsklinikum Tuebingen | |
| Tuebingen, Germany, D-72076 | |
| Universitats - Kinderklinik | |
| Greiswald, Germany, 17487 | |
| Universitatsklinik Homburg | |
| Homburg, Germany, 66421 | |
| Universitatsklinikum Carl Gustav Carl Carus | |
| Dresden, Germany, D-01307 | |
| Universitaetsklinikum Goettingen | |
| Goettingen, Germany, D-37075 | |
| University Hospital Schleswig-Holstein - Kiel Campus | |
| Kiel, Germany, D-24105 | |
| Urologische Klinik - Universitaetsklinikum Aachen | |
| Aachen, Germany, D-52074 | |
| Vestische Kinderklinik | |
| Datteln, Germany, 45704 | |
| Westpfalz-Klinikum GmbH | |
| Kaiserslautern, Germany, D-67653 | |
| Zentralklinikum Augsburg | |
| Augsburg, Germany, DOH-86156 | |
| Zentralkrankenhaus | |
| Bremen, Germany, D-28205 | |
| Netherlands | |
| Academisch Ziekenhuis Maastricht | |
| Maastricht, Netherlands, 6202 AZ | |
| Switzerland | |
| Kinderspital Luzerne | |
| Luzerne 16, Switzerland, CH-6000 | |
| Ospedale "la Carita", Locarno | |
| Locarno, Switzerland, 6600 | |
| University Children's Hospital | |
| Zurich, Switzerland, CH-8032 | |
| University Children's Hospital | |
| Basel, Switzerland, CH-4005 | |
| Study Chair: | Frank Berthold, MD | Children's Hospital |
More Information
| Study ID Numbers: | CDR0000068664, GPOH-GERMANY-NB97, EU-20102, GER-GPOH-NB97 |
| Study First Received: | June 6, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00017225 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma |
stage 4S neuroblastoma recurrent neuroblastoma localized unresectable neuroblastoma |
|
Melphalan Dacarbazine Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Vindesine Cyclophosphamide Antibiotics, Antineoplastic Neuroblastoma Keratolytic Agents Cisplatin Neoplasms, Germ Cell and Embryonal |
Therapeutic Uses Dermatologic Agents Alkylating Agents Etoposide Neoplasms by Histologic Type Mitosis Modulators Vincristine Antimitotic Agents Carboplatin Immunosuppressive Agents Doxorubicin Pharmacologic Actions Neuroectodermal Tumors Neoplasms Ifosfamide |
