CClinicalTrials.gg
CompletedNCT00025623Updated Sep 17, 2013

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

A Phase 2 interventional study of carboplatin and cyclophosphamide in Neuroblastoma, sponsored by European Infant Neuroblastoma Study Group - 1999. Completed at 11 sites in 11 countries. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by European Infant Neuroblastoma Study Group - 1999 · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Ages
Up to 1 Year
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Neuroblastoma

Browse trials for

Keywords

  • disseminated neuroblastoma
03

In context

Neuroblastoma

625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

Browse Neuroblastoma studies →

Lead sponsor

European Infant Neuroblastoma Study Group - 1999 is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • Drugcarboplatin
  • Drugcyclophosphamide
  • Drugdoxorubicin hydrochloride
  • Drugetoposide
  • Drugvincristine sulfate
  • Procedureconventional surgery
06

Study locations

11 sites
  • St. Anna Children's Hospital
    Vienna, A-1090, Austria
  • Universitair Ziekenhuis Gent
    Ghent, B-9000, Belgium
  • Rigshospitalet
    Copenhagen, 2100, Denmark
  • Centre Hospitalier Regional de Purpan
    Toulouse, 31026, France
  • Istituto Giannina Gaslini
    Genoa, 16148, Italy
  • Rikshospitalet University Hospital
    Oslo, 0027, Norway
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
    Lisboa, 1099-023 Codex, Portugal
  • Hospital Universitario LA FE
    Valencia, 46009, Spain
  • Ostra Sjukhuset
    Gothenburg, 41685, Sweden
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, CH-1011, Switzerland
  • Bristol Royal Hospital for Children
    Bristol, England BS2 8BJ, United Kingdom
07

References and documents

Publications

  • De Bernardi B, Gerrard M, Boni L, Rubie H, Canete A, Di Cataldo A, Castel V, Forjaz de Lacerda A, Ladenstein R, Ruud E, Brichard B, Couturier J, Ellershaw C, Munzer C, Bruzzi P, Michon J, Pearson AD. Excellent outcome with reduced treatment for infants with disseminated neuroblastoma without MYCN gene amplification. J Clin Oncol. 2009 Mar 1;27(7):1034-40. doi: 10.1200/JCO.2008.17.5877. Epub 2009 Jan 26. PubMed 19171711 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00025623
Lead sponsor
European Infant Neuroblastoma Study Group - 1999
First posted
Jan 27, 2003
Start date
Jul 1999
Completion
Mar 2009
Last update
Sep 17, 2013

Study contacts

Bruno De Bernardi, MD
study chair · Istituto Giannina Gaslini
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2002. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion