Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma

September 16, 2013 updated by: European Infant Neuroblastoma Study Group - 1999

European Infant Neuroblastoma Study - Stage 4S and Stage 4 (No Bone, Lung, Pleura or CNS); MYCN Not Amplified

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 may kill more tumor cells.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Confirm that the outcome for infants with newly diagnosed stage IV or IVS neuroblastoma without MYCN amplification is not altered by treatment with etoposide and carboplatin followed by cyclophosphamide, doxorubicin, and vincristine.
  • 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 are stratified according to age (under 1 month vs over 1 month).

Infants less than 1 month of age are further stratified according to Philadelphia score (less than 1 vs at least 1). Infants over 1 month of age are also further stratified according to Philadelphia score (less than 2 vs at least 2).

Infants under 1 month of age with Philadelphia score of less than 1 and infants over 1 month of age with Philadelphia score of less than 2 undergo observation only. Infants under 1 month of age with Philadelphia score of at least 1 and infants over 1 month of age with Philadelphia score of at least 2 receive VP-CARBO chemotherapy.

  • VP-CARBO chemotherapy: Patients receive etoposide IV over 2 hours and carboplatin IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 courses. Patients with no response receive CADO chemotherapy.
  • CADO chemotherapy: Patients receive 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 a maximum of 4 courses.

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

PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study within 4 years.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • St. Anna Children's Hospital
  • Belgium
      • Ghent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • France
      • Toulouse, France, 31026
        • Centre Hospitalier Regional de Purpan
  • Italy
      • Genoa, Italy, 16148
        • Istituto Giannina Gaslini
  • Norway
      • Oslo, Norway, 0027
        • Rikshospitalet University Hospital
  • Portugal
      • Lisboa, Portugal, 1099-023 Codex
        • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
  • Spain
      • Valencia, Spain, 46009
        • Hospital Universitario la Fe
  • Sweden
      • Gothenburg, Sweden, 41685
        • Östra Sjukhuset
  • Switzerland
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS2 8BJ
        • Bristol Royal Hospital for Children
      • Sheffield, England, United Kingdom, S10 2TH
        • Children's Hospital - Sheffield

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed stage IV or IVS neuroblastoma or ganglioneuroblastoma

    • Metastases confined to marrow, skin, nodes, or liver

      • No metastases to bone (radiologic bone lesions in skeleton), CNS, pleura, or lung
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Infant Neuroblastoma Study Group - 1999

Investigators

  • Study Chair: Mary P. Gerrard, MBChB, FRCP, FRCPCH, Children's Hospital - Sheffield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

November 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068979
  • EURO-INF-NB-STUDY-1999-99.2
  • EU-20125B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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