Combination Chemotherapy Followed by Surgery and Peripheral Stem Cell or Bone Marrow Transplantation in Treating Infants With Newly Diagnosed Neuroblastoma

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

European Infant Neuroblastoma Study - Stage 2, 3, 4, and 4S; MYCN Amplified Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the survival of infants with newly diagnosed stage II, III, IV, or IVS neuroblastoma with MYCN amplification treated with etoposide, carboplatin, cyclophosphamide, doxorubicin, and vincristine followed by surgery and busulfan and melphalan with autologous peripheral blood stem cell or bone marrow transplantation.
  • Determine whether there are 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 then 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.

Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days. Patients undergo leukapheresis to collect peripheral blood stem cells (PBSC). Patients who do not mobilize sufficient cells undergo bone marrow harvest.

Patients eligible for surgery undergo surgical resection. Patients with stage IV disease with less than complete response of metastatic disease after initial chemotherapy are removed from the study.

Beginning within 2 weeks after surgery, patients receive 1 additional course of VP-CARBO chemotherapy followed by 1 additional course of CADO chemotherapy.

After at least 3 weeks, patients receive high-dose chemotherapy comprising busulfan IV over 24 hours on days -7 to -3 and melphalan IV on day -2. PBSC or bone marrow are reinfused on day 0.

At least 2 months after the completion of high-dose chemotherapy and bone marrow or PBSC transplantation, patients undergo radiotherapy to the primary site, according to preoperative imaging studies. Patients are treated with oral tretinoin after megatherapy.

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

PROJECTED ACCRUAL: A total of 40 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

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 II, III, IV, or IVS neuroblastoma or ganglioneuroblastoma
  • MYCN amplification (i.e., at least 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: Adela Canete, MD, PhD, Hospital Universitario La Fe

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

December 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068982
  • EURO-INF-NB-STUDY-1999-99.4
  • EU-20125D

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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