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Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2002 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on June 6, 2001.   Last Updated on February 6, 2009   History of Changes
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: Primary Purpose: Treatment
Official Title: Neuroblastoma Study Phase II Study of Various Therapies in Patients With Neuroblastoma

Resource links provided by NLM:

Genetics Home Reference related topics: neuroblastoma
MedlinePlus related topics: Bone Marrow Transplantation Cancer Neuroblastoma
Drug Information available for: Cyclophosphamide Vincristine Cisplatin Doxorubicin Doxorubicin hydrochloride Etoposide Carboplatin Vindesine Etoposide phosphate Filgrastim Lenograstim Granulocyte colony-stimulating factor Melphalan Tretinoin Sarcolysin Vincristine sulfate Melphalan hydrochloride Ifosfamide Dacarbazine
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 1997
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Simon T, Hero B, Bongartz R, Schmidt M, Muller 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, Gruttner 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 01.
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.
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.

ClinicalTrials.gov Identifier: NCT00017225     History of Changes
Other Study ID Numbers: CDR0000068664, GPOH-GERMANY-NB97, EU-20102, GER-GPOH-NB97
Study First Received: June 6, 2001
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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
Isophosphamide mustard
Cisplatin
Cyclophosphamide
Dacarbazine
Doxorubicin
 Etoposide
Ifosfamide
Melphalan
Tretinoin
Vincristine
Vindesine
Carboplatin
Lenograstim
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2012



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