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Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma

This study is ongoing, but not recruiting participants.

Sponsored by: European Infant Neuroblastoma Study Group - 1999
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025623
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.


Condition Intervention Phase
Neuroblastoma
Drug: carboplatin
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: vincristine sulfate
Procedure: conventional surgery
Phase II

MedlinePlus related topics:   Cancer    Neuroblastoma   

Drug Information available for:   Doxorubicin    Doxorubicin hydrochloride    Cyclophosphamide    Carboplatin    Etoposide    Vincristine sulfate    Vincristine    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   European Infant Neuroblastoma Study - Stage 4 With Bone, Lung, Pleura or CNS Involvement; MYCN Not Amplified

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

Study Start Date:   July 1999

Detailed Description:

OBJECTIVES:

  • Confirm that the management of infants with newly diagnosed stage IV neuroblastoma without MYCN amplification treated with etoposide and carboplatin and cyclophosphamide, doxorubicin, and vincristine followed by surgery does not require intensive high-dose chemotherapy consolidation.
  • Determine whether deletion of chromosome 1p or diploidy/tetraploidy are prognostic factors in these patients.
  • Determine whether there are other prognostic criteria that could be used in future therapeutic stratification of these patients.

OUTLINE: This is a multicenter study.

Patients receive VP-CARBO chemotherapy comprising etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses.

Patients without disease progression receive 2 additional courses of VP-CARBO chemotherapy. Patients with metastatic complete response (CR) undergo surgical resection of primary disease.

Patients with disease progression after 2 or 4 courses of VP-CARBO chemotherapy receive CADO chemotherapy comprising cyclophosphamide IV over 1 hour on days 1-5, doxorubicin IV over 6 hours on days 4 and 5, and vincristine IV on days 1 and 5. Treatment repeats every 21 days for 2 courses.

After 2 courses of CADO chemotherapy, patients with metastatic CR undergo surgical resection of primary disease. Patients with residual disease receive 2 additional courses of CADO chemotherapy. Patients with residual disease after 4 courses of CADO chemotherapy are removed from the study. Patients with metastatic CR after additional CADO chemotherapy undergo surgical resection of primary disease.

Patients are followed within 6 months and then annually for 5 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 4 years.

  Eligibility
Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed stage IV neuroblastoma or ganglioneuroblastoma

    • Metastases to bone, CNS, or pleura/lung by x-ray or CT scan
  • No MYCN amplification (i.e., fewer than 10 copies)

PATIENT CHARACTERISTICS:

Age:

  • Under 12 months at diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025623

Locations
Austria
St. Anna Children's Hospital    
      Vienna, Austria, A-1090
Belgium
Universitair Ziekenhuis Gent    
      Ghent, Belgium, B-9000
Denmark
Rigshospitalet    
      Copenhagen, Denmark, 2100
France
Centre Hospitalier Regional de Purpan    
      Toulouse, France, 31026
Italy
Istituto Giannina Gaslini    
      Genoa, Italy, 16148
Norway
Rikshospitalet University Hospital    
      Oslo, Norway, 0027
Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.    
      Lisboa, Portugal, 1099-023 Codex
Spain
Hospital Universitario LA FE    
      Valencia, Spain, 46009
Sweden
Ostra Sjukhuset    
      Gothenburg, Sweden, 41685
Switzerland
Centre Hospitalier Universitaire Vaudois    
      Lausanne, Switzerland, CH-1011
United Kingdom, England
Bristol Royal Hospital for Children    
      Bristol, England, United Kingdom, BS2 8BJ

Sponsors and Collaborators
European Infant Neuroblastoma Study Group - 1999

Investigators
Study Chair:     Bruno De Bernardi, MD     Istituto Giannina Gaslini    
  More Information


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

Study ID Numbers:   CDR0000068980, EURO-INF-NB-STUDY-1999-99.3, EU-20125C
First Received:   October 11, 2001
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00025623
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
disseminated neuroblastoma  

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Vincristine
Cyclophosphamide
Carboplatin
Etoposide phosphate
Neuroblastoma
Doxorubicin
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Etoposide
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on December 03, 2008




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