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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00017225
First Posted: January 27, 2003
Last Update Posted: August 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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 2

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:


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

Study Start Date: May 1997
Study Completion Date: February 2002
  Show Detailed Description

  Eligibility

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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Submitted: June 6, 2001
First Posted: January 27, 2003
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