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Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma Clinical research trials and Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma. Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma clinical trial. Participants oftentimes recieve the finest healthcare available for their Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
For Condition: localized resectable neuroblastoma,disseminated neuroblastoma,regional neuroblastoma,stage 4S neuroblastoma,localized unresectable neuroblastoma,recurrent neuroblastoma
Status: Recruiting
Sponsor(s): Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany ,
Synopsis: 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.
Details: OBJECTIVES: - Determine the frequency of spontaneous remission in pediatric patients with localized neuroblastoma. - Determine the course of regression in patients with spontaneous remission. - Determine the event-free survival rate of patients with high-risk neuroblastoma treated with maintenance chemotherapy OR consolidation chemotherapy followed by autologous stem cell rescue. - Determine if a correlation exists between long-term overall survival and catecholamine response in these high-risk patients. - Determine if a correlation exists between cytotoxic and conditioning chemotherapies, in terms of bone marrow toxicity, in these high-risk patients. OUTLINE: This is a multicenter study. Patients are stratified according to risk (low vs standard vs high). - Observation stratum (low risk): Patients undergo surgical biopsy followed by observation for 6-12 months. Patients may also undergo second-look surgery. Patients with tumor regression receive no further therapy. Patients with disease progression or no tumor regression receive standard-risk chemotherapy as in the standard-risk stratum. - Patients undergo surgical biopsy. Patients at least 6 months of age receive 1 course of chemotherapy comprising cisplatin IV and etoposide IV continuously on days 1-4 and vindesine IV over 1 hour on day 1. Patients then receive 1 course of chemotherapy comprising vincristine IV over 1 hour on days 1 and 8, dacarbazine IV over 1 hour on days 1-5, ifosfamide IV continuously on days 1-5, and doxorubicin IV over 4 hours on days 6 and 7. Patients under 6 months of age receive doxorubicin IV over 30 minutes and vincristine IV on days 1, 3, and 5 and cyclophosphamide IV over 5 minutes on days 1-7. Treatment repeats every 3 weeks for 2 courses in the absence of unacceptable toxicity. After chemotherapy, patients may undergo second-look surgery followed by 2 additional courses of chemotherapy as above. Patients with complete response or very good partial response receive no further therapy. Patients with partial response, minimal response, no response, or progressive disease undergo local radiotherapy daily 5 days a week for approximately 6 weeks. Patients with no response after radiotherapy may then receive therapy as in the high-risk stratum. - Patients undergo surgical biopsy. Patients at least 6 months of age receive induction chemotherapy comprising cisplatin, etoposide, and vindesine as in the standard-risk stratum combined with filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 8 and continuing until blood counts recover. Patients also receive alternating courses of vincristine, dacarbazine, ifosfamide, and doxorubicin as in the standard-risk stratum combined with G-CSF SC daily beginning on day 9 and continuing until blood counts recover. Treatment repeats every 3 weeks for up to 6 courses in the absence of unacceptable toxicity. Patients under 6 months of age receive 2 courses of induction chemotherapy as in the standard-risk stratum followed by 4 courses of alternating chemotherapy as above. Patients may also undergo second-look surgery. Patients then receive consolidation chemotherapy comprising melphalan IV over 30 minutes on days -8 to -5, etoposide IV over 4 hours on day -4, and carboplatin IV over 1 hour on days -4 to -2. Patients undergo autologous stem cell transplantation (ASCT) on day 0. Patients also receive G-CSF SC or IV over 2 hours daily beginning on day 0. Patients may then undergo radiotherapy daily 5 days a week for 6 weeks. Patients who were diagnosed less than 1 year ago and who do not demonstrate MYCN amplication receive maintenance chemotherapy comprising oral cyclophosphamide on days 1-8 (instead of consolidation chemotherapy and ASCT as above). Treatment repeats every 3 weeks for 4 courses. Beginning 4-6 weeks after transplantation or 4 weeks after initiation of the last course of maintenance chemotherapy, all patients receive consolidation therapy with oral tretinoin 3 times daily on days 1-14. Treatment repeats every 28 days for 6 courses followed by a 3-month rest. Patients then receive 3 additional courses. Patients are followed at 6 weeks, every 3 months for 5 years, and then every 6 months thereafter. PROJECTED ACCRUAL: Approximately 130 patients (50 in high-risk stratum, 15 in standard-risk stratum, and 65 in observation stratum) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /20 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed neuroblastoma - Observation stratum: - MYCN gene not amplified - Infants with stage I-IVS disease OR - Over 1 year of age and stage I or II resectable disease - Standard-risk stratum: - MYCN gene not amplified - Infants with serious symptoms and stage II-IVS disease OR - Over 1 year of age with stage II or III unresectable disease - High-risk stratum: - Stage IV disease OR - Stage I-IVS MYCN gene-amplified disease PATIENT CHARACTERISTICS: Age: - 20 and under Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - No kidney insufficiency Cardiovascular: - No cardiac insufficiency Other: - Not pregnant - Fertile patients must use effective contraception - No other serious illness PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy within 6 months after diagnosis Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrankBerthold, Study Chair, Children's Hospital
Vestische Kinderklinik *Recruiting*
Datteln, , 45704
Germany
Recruiting W. Andler 49-02363-975-0
Universitats - Kinderklinik *Recruiting*
Rostock, , 18057
Germany
Recruiting G Eggers 49-381-4940
Helios Klinikum Erfurt GmbH *Recruiting*
Erfurt, , 99012
Germany
Recruiting Sauerbrey 49-361-7814603
Caritaskrankenhaus *Recruiting*
Bad Mergentheim, , 97980
Germany
Recruiting K. Rager 49-7931-580
Mutterhaus der Borromaerinnen *Recruiting*
Trier, , D-54219
Germany
Recruiting Wolfgang Rauh 49-651-947-2654
Universitats - Kinderklinik *Recruiting*
Greiswald, , 17487
Germany
Recruiting J.F. Beck 49-383-486-6325
Medizinische Hochschule Hannover *Recruiting*
Hannover, , D-30625
Germany
Recruiting Karl Welte 49-511-532-9123
St. Marien Hospital *Recruiting*
Hamm, , 59065
Germany
Recruiting L Reinken 49-2381-181905
University Children's Hospital *Recruiting*
Basel, , CH-4005
Switzerland
Recruiting Thomas Kuhne 41-61-691-2626
Kinderkrankenhaus *Recruiting*
Kassel, , 34121
Germany
Recruiting M. Wright 49-561-9285-108
Universitas - Kinderklinik *Recruiting*
Freiburg, , 79106
Germany
Recruiting Charlotte Niemeyer 49-761-270-4552
Deutsches Rotes Kreuz *Recruiting*
Siegen, , 57072
Germany
Recruiting F Gobel 049-271-2345-225
Humboldt Universitaet Berlin-Campus Virchow Klinikum *Recruiting*
Berlin, , D-13353
Germany
Recruiting Gunter Henze 49-30-450-566354
Universitaetsklinikum Tuebingen *Recruiting*
Tuebingen, , D-72076
Germany
Recruiting D. Niethammer 49-7071-29-83781
Kinderspital Luzern *Recruiting*
Luzern 16, , CH-6000
Switzerland
Recruiting U Caflisch 41-41-205-1111
Klinikum Nuernberg - Klinikum Sued *Recruiting*
Nuernberg, , D-90471
Germany
Recruiting Schwarzer 49-911-398-2290
Gemeinschaftskrankenhaus *Recruiting*
Herdecke, , 58313
Germany
Recruiting Ch. Tautz 00492330-624242
Martin Luther Universitaet *Recruiting*
Halle, , 06097
Germany
Recruiting Stefan Burdach 49-345-557-2492
Krankenanstalten Gilead *Recruiting*
Biefeld, , 33617
Germany
Recruiting N Jorch 49-521-144-2730
Urologische Klinik Universitats Klinikum Aachen *Recruiting*
Aachen, , D-52074
Germany
Recruiting R. Mertens 49-241-80-89222
Staedtisches Krankenhaus Muenchen - Harlaching *Recruiting*
Munich, , D-81545
Germany
Recruiting P.K. Klose 49-89-62102710
Universitaets - Kinderklinik *Recruiting*
Lubeck, , 23538
Germany
Recruiting Peter Bucsky 49-451-500-2956
Kinderklinik d. TU / Schwabing *Recruiting*
Munich, , 80804
Germany
Recruiting Stephan Muller-Weihrich 49-89-3068-2352
Krankenhaus D Barmherzigen Brueder *Recruiting*
Regensburg, , 93049
Germany
Recruiting J Wolff 49-941-369-5404
Saarbrucker Winterbergkliniken *Recruiting*
Saarbrucken, , 66119
Germany
Recruiting R Geib-Konig 49-681-963-2575
Kindershospital *Recruiting*
Osnabruck, , 49082
Germany
Recruiting K. Von Muhlendahl 49-541-5602-0
Klinikum Kassel *Recruiting*
Kassel, , D-34125
Germany
Recruiting Martina Rodehuiser 49-561-980-3066
Klinikum Coburg *Recruiting*
Coburg, , 96450
Germany
Recruiting Roland Frank 49-9561-22-5547
Universitaet Ulm *Recruiting*
Ulm, , D-89075
Germany
Recruiting K. Debatin 49-731-5002-7790
Johannes Gutenberg University *Recruiting*
Mainz, , D-55131
Germany
Recruiting P. Gutjahr 49-6131-17-2112
Universitatsklinikum Carl Gustav Carl Carus *Recruiting*
Dresden, , D-01307
Germany
Recruiting M Suttorp 49-351-458-2479
Witten University - Klinikum Wuppertal *Recruiting*
Wuppertal, , D-42283
Germany
Recruiting B. Dohrn 49-202-896-2441
Klinikum Minden *Recruiting*
Minden, , D-32423
Germany
Recruiting W Tilmann 49-571-801-4601
Stadt. Klinik - Kinderklinik *Recruiting*
Mannheim, , 68167
Germany
Recruiting M. Ebinger 49-621-383-2244
St. Marien Hospital *Recruiting*
Vechta, , D-49377
Germany
Recruiting H. Koch 49-4441-99-1262
Universitaetsklinik Duesseldorf *Recruiting*
Duesseldorf, , D-40225
Germany
Recruiting Ulrich Goebel 49-211-811-7680
Universitaets - Kinderklinik *Recruiting*
Leipzig, , 04317
Germany
Recruiting Korholz 49-341-97-26246
Universitatsklinik Homburg *Recruiting*
Homburg, , 66421
Germany
Recruiting N. Graf 49-6841-162-4000
Kreiskrankenhaus Gummersbach GMBH *Recruiting*
Gummersbach, , D-51643
Germany
Recruiting E Pretel 49-2261-17-1601
Helios Klinikum Berlin *Recruiting*
Berlin, , 13122
Germany
Recruiting W. Dorffel 49-30-9401-2352
Altonaer Kinderkrankenhaus *Recruiting*
Hamburg, , 22763
Germany
Recruiting P. Reifferscheid 49-40-8833-0
Reinhard - Nieter - Krankenhaus *Recruiting*
Wilhelmshaven, , 26389
Germany
Recruiting H Krohn 49-4421-891840
Universitaetsklinik Goettingen *Recruiting*
Goettingen, , D-37075
Germany
Recruiting Lothar Schweigerer 49-551-39-6200
Diakone - Krankenhaus *Recruiting*
Schwabisch Hall, , 74523
Germany
Recruiting Fahr 49-791-7530
Universitaets - Kinderklinik Wuerzburg *Recruiting*
Wuerzburg, , D-97080
Germany
Recruiting Joachim Kuehl 49-931-201-27796
Kinderkrankenhaus auf der Bult *Recruiting*
Hannover, , 30173
Germany
Recruiting U. Hofmann 49-511-81150
Staedtische Klinikum-Kinderklinik *Recruiting*
Rosenheim, , 83022
Germany
Recruiting P. Peller 49-8031-3951
Stadt. Kinderklinik *Recruiting*
Gelsenkirchen, , 45892
Germany
Recruiting E. Stemmann 49-209-369-1
Universitaets - Kinderklinik *Recruiting*
Erlangen, , D-91054
Germany
Recruiting J.D. Beck 49-9131-853-3118
Stadt Kinderkrankenhaus *Recruiting*
Koln - Riehl, , 50735
Germany
Recruiting W Sternschulte 49-221-8907-5243
Olgahospital *Recruiting*
Stuttgart, , DOH-70176
Germany
Recruiting Jorn Treuner 49-711-992-2400
Stadt. Kinderklinik *Recruiting*
Karlsruhe, , 76131
Germany
Recruiting W Dupuis 49-721-974-3265
Klinikum Lippe - Detmold *Recruiting*
Detmold, , 32756
Germany
Recruiting K Wesseler 49-523-172-4511
Universitaets-Kinderklinik Heidelberg *Recruiting*
Heidelberg, , D-69120
Germany
Recruiting A. Kulozik 49-6221-564-555
Universitaets-Krankenhaus Eppendorf *Recruiting*
Hamburg, , D-20246
Germany
Recruiting Rudolf Erttman 49-40-4717-4270
Kinderklinik *Recruiting*
Giessen, , D-35385
Germany
Recruiting Alfred Reiter 49-641-994-3420
Universitaetsklinikum Essen *Recruiting*
ESSEN, , D-45122
Germany
Recruiting Werner Havers 0201-723-2453
Kinderklinik *Recruiting*
Munich, , DOH-80337
Germany
Recruiting I. Schmid 49-89-5160-2842
University Hospital Schleswig-Holstein - Kiel Campus *Recruiting*
Kiel, , D-24105
Germany
Recruiting A. Claviez 49-431-597-1622
Johanniter-Kinderklinik *Recruiting*
St. Augustin, , 53757
Germany
Recruiting R Dickerhoff 22-41-2491
Stadt. KH Dresden - Neustadt *Recruiting*
Dresden, , 01229
Germany
Recruiting W Kotte 49-351-8562502
Universitaets - Kinderklinik *Recruiting*
Jena, , D-07745
Germany
Recruiting F. Zintl 49-3641-9300
Zentralklinikum Augsburg *Recruiting*
Augsburg, , DOH-86156
Germany
Recruiting Astrid Gnekow 49-821-400-3603
Medizinische Universitaetsklinik I *Recruiting*
Cologne, , D-50924
Germany
Recruiting Frank Berthold 49-221-478-4380
Cnopfche Kinderklinik *Recruiting*
Nuernberg, , 90419
Germany
Recruiting W Scheurlen 49-911-3340-02
Klinikum Chemnitz GMBH *Recruiting*
Chemnitz, , D-09116
Germany
Recruiting K. Hofmann 49-371-333-241-24
Zentralkrankenhaus *Recruiting*
Bremen, , D-28205
Germany
Recruiting H.J. Spaar 49-421-497-3656
Kinderkrankenhaus Josefinum *Recruiting*
Augsburg, , 86154
Germany
Recruiting E Pontgratz 49-821-2412-200
Praxis am Evangelishes Krankenhaus Bethanien *Recruiting*
Iserlohn, , D-58644
Germany
Recruiting F. Knust 49-2371-212-300
Ospedale "la Carita", Locarno *Recruiting*
Locarno, , 6600
Switzerland
Recruiting Luisa Buetti 41-91-756-7552
Stadtische Kliniken *Recruiting*
Oldenburg, , 26133
Germany
Recruiting Hermann Muller 49-441-403-2013
St. Barbara Krankenhaus *Recruiting*
Halle, , 06003
Germany
Recruiting G. Guenther 49-345-48250
Carl - Thiem - Klinkum Cottbus *Recruiting*
Cottbus, , D-03048
Germany
Recruiting D Mobius 49-355-462336
Westpfalz-Klinikum GmbH *Recruiting*
Kaiserslautern, , D-67653
Germany
Recruiting G. Rupprath 49-631-203-1872
Klinikum Bayreuth *Recruiting*
Bayreuth, , 95445
Germany
Recruiting G Wundisch 49-921-4006202
St. Annastift Krankenhaus *Recruiting*
Ludwigshafen, , D-67065
Germany
Recruiting H. Dominich 49-621-57021
Universitaets Klinik fuer Kinderchirurgie *Recruiting*
Leipzig, , D-04317
Germany
Recruiting Trobs 49-341-9726747
Klinikum Krefeld GmbH *Recruiting*
Krefeld, , D-47805
Germany
Recruiting S. Volpel 49-2151-32-2375
Kinderklinik der Universitaet-Bonn *Recruiting*
Bonn, , DOH-53113
Germany
Recruiting Udo Bode 49-228-287-3215
Universitaets - Kinderpoliklinik *Recruiting*
Munich, , 80336
Germany
Recruiting Ch. Bender-Gotze 49-89-5160-3677
Klinikum Schwerin *Recruiting*
Schwerin, , D-19049
Germany
Recruiting D. Neubert 49-385-892660-1
Stadt Klinikum - Howedestrase *Recruiting*
Braunschweig, , 38118
Germany
Recruiting G Mau 49-531-595-1222
Klinik und Poliklinik fuer Kinderheilkunde *Recruiting*
Muenster, , D-48149
Germany
Recruiting Herbert Juergens 49-251-834-7742
Universitatsklinikum der MA *Recruiting*
Magdeburg, , 39112
Germany
Recruiting U Mittler 49-391-67-17210
Universitaets - Kinderklinik *Recruiting*
Marburg, , 35033
Germany
Recruiting H. Christiansen 49-6421-286-2650
Staedtische Krankenhaus Kiel *Recruiting*
Kiel, , 23116
Germany
Recruiting Christian Klinggraeff 49-431-1697-1800
Leopoldina - Krankenhaus *Recruiting*
Schwienfurt, , 97422
Germany
Recruiting H Giesen 49-9721-7203312
Academisch Ziekenhuis Maastricht *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting B. Granzen 31-43-387-5239
Kinderklinik Kohlhof *Recruiting*
Neunkirchen, , 66539
Germany
Recruiting O. Schofer 49-6821-363-220/221
Klinik Konstanz *Recruiting*
Konstanz, , 78461
Germany
Recruiting H. Schwenk 49-7531-801-1651
Klinikum der J.W. Goethe Universitaet *Recruiting*
Frankfurt, , D-60590
Germany
Recruiting T. Klingebiel 49-69-6301-5243
Stadt. Kliniken *Recruiting*
Dortmund, , 44123
Germany
Recruiting H. Breu 49-231-5021721
Marien Hospital *Recruiting*
Homburg, , D-66421
Germany
Recruiting B Rodeck 49-6841-162-3002
Stadt. Krankenhaus Kemperhof *Recruiting*
Koblenz, , 56065
Germany
Recruiting M. Rister 49-261-499-2602
University Children's Hospital *Recruiting*
Zurich, , CH-8032
Switzerland
Recruiting Felix Niggli 41-1-266-7111
Additional Information:
Study ID Numbers: CDR0000068664; GPOH-GERMANY-NB97,GER-GPOH-NB97,EU-20102
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017225
Other Disseminated Neuroblastoma Studies:
1. Surgery in Treating Children With Neuroblastoma
2. Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma
3. Isotretinoin With or Without Monoclonal Antibody, Interleukin 2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma
4. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
5. Chemotherapy and Surgery Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Neuroblastoma
Related Studies:
Other disseminated neuroblastoma Clinical Trials
Other Clinical Trials
Other Stuttgart Clinical Trials
Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
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