Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

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ClinicalTrials.gov Identifier: NCT00017225

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : August 2, 2013

Sponsor:

Information provided by:

National Cancer Institute (NCI)

Study Description

Brief Summary:

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 or disease	Intervention/treatment	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 2

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Study Design


Study Type :	Interventional (Clinical Trial)
Primary Purpose:	Treatment
Official Title:	Neuroblastoma Study Phase II Study of Various Therapies in Patients With Neuroblastoma
Study Start Date :	May 1997
Actual Study Completion Date :	February 2002

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Neuroblastoma

MedlinePlus related topics: Neuroblastoma

Genetic and Rare Diseases Information Center resources: Neuroblastoma Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 20 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017225

Show 94 Study Locations

Sponsors and Collaborators

Gesellschaft fur Padiatrische Onkologie und Hamatologie - Germany

Investigators


Study Chair:	Frank Berthold, MD	Children's Hospital Medical Center, Cincinnati

More Information

Publications of Results:

Simon T, Hero B, Bongartz R, Schmidt M, Müller RP, Berthold F. Intensified external-beam radiation therapy improves the outcome of stage 4 neuroblastoma in children > 1 year with residual local disease. Strahlenther Onkol. 2006 Jul;182(7):389-94.

Kremens B, Hero B, Esser J, Weinel P, Filger-Brillinger J, Fleischhack G, Graf N, Grüttner HP, Niemeyer C, Schulz A, Wickmann L, Berthold F. Ocular symptoms in children treated with human-mouse chimeric anti-GD2 mAb ch14.18 for neuroblastoma. Cancer Immunol Immunother. 2002 Apr;51(2):107-10. Epub 2002 Feb 1.

Other Publications:

Krams M, Hero B, Berthold F, Parwaresch R, Harms D, Rudolph P. Proliferation marker KI-S5 discriminates between favorable and adverse prognosis in advanced stages of neuroblastoma with and without MYCN amplification. Cancer. 2002 Feb 1;94(3):854-61.

Simon T, Hero B, Dupuis W, Selle B, Berthold F. The incidence of hearing impairment after successful treatment of neuroblastoma. Klin Padiatr. 2002 Jul-Aug;214(4):149-52.

Spitz R, Hero B, Westermann F, Ernestus K, Schwab M, Berthold F. Fluorescence in situ hybridization analyses of chromosome band 1p36 in neuroblastoma detect two classes of alterations. Genes Chromosomes Cancer. 2002 Jul;34(3):299-305.

Hero B, Simon T, Spitz R, Ernestus K, Gnekow AK, Scheel-Walter HG, Schwabe D, Schilling FH, Benz-Bohm G, Berthold F. Localized infant neuroblastomas often show spontaneous regression: results of the prospective trials NB95-S and NB97. J Clin Oncol. 2008 Mar 20;26(9):1504-10. doi: 10.1200/JCO.2007.12.3349.

Simon T, Hero B, Benz-Bohm G, von Schweinitz D, Berthold F. Review of image defined risk factors in localized neuroblastoma patients: Results of the GPOH NB97 trial. Pediatr Blood Cancer. 2008 May;50(5):965-9.

Berthold F, Hero B, Kremens B, Handgretinger R, Henze G, Schilling FH, Schrappe M, Simon T, Spix C. Long-term results and risk profiles of patients in five consecutive trials (1979-1997) with stage 4 neuroblastoma over 1 year of age. Cancer Lett. 2003 Jul 18;197(1-2):11-7.

Spitz R, Hero B, Ernestus K, Berthold F. Deletions in chromosome arms 3p and 11q are new prognostic markers in localized and 4s neuroblastoma. Clin Cancer Res. 2003 Jan;9(1):52-8.

Spitz R, Hero B, Ernestus K, Berthold F. FISH analyses for alterations in chromosomes 1, 2, 3, and 11 define high-risk groups in neuroblastoma. Med Pediatr Oncol. 2003 Jul;41(1):30-5.

Spitz R, Hero B, Ernestus K, Berthold F. Gain of distal chromosome arm 17q is not associated with poor prognosis in neuroblastoma. Clin Cancer Res. 2003 Oct 15;9(13):4835-40.

von Schweinitz D, Hero B, Berthold F. The impact of surgical radicality on outcome in childhood neuroblastoma. Eur J Pediatr Surg. 2002 Dec;12(6):402-9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


ClinicalTrials.gov Identifier:	NCT00017225 History of Changes
Other Study ID Numbers:	GPOH-GERMANY-NB97 CDR0000068664 ( Registry Identifier: PDQ (Physician Data Query) ) EU-20102 GER-GPOH-NB97
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	August 2, 2013
Last Verified:	August 2002

Keywords provided by National Cancer Institute (NCI):


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

Additional relevant MeSH terms:


Neuroblastoma 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 Cyclophosphamide Melphalan Ifosfamide Liposomal doxorubicin Carboplatin	Doxorubicin Etoposide Vincristine Tretinoin Vindesine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic

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