Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma

Phase 2

Completed

• Conditions: Neuroblastoma

• Registration Number: NCT00025610
• Lead Sponsor: European Infant Neuroblastoma Study Group - 1999

Brief 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 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.

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 Timeline

• Study Start: 1999-07
• Study First Submitted: 2001-10-11
• Status Verified: 2001-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2009-03
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (12)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

St. Anna Children's Hospital; 🇦🇹 Vienna, Austria

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Istituto Giannina Gaslini; 🇮🇹 Genoa, Italy

Centre Hospitalier Regional de Purpan; 🇫🇷 Toulouse, France

Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.; 🇵🇹 Lisboa, Portugal

Hospital Universitario LA FE; 🇪🇸 Valencia, Spain

Rikshospitalet University Hospital; 🇳🇴 Oslo, Norway

Ostra Sjukhuset; 🇸🇪 Gothenburg, Sweden

Bristol Royal Hospital for Children; 🇬🇧 Bristol, England, United Kingdom

Children's Hospital - Sheffield; 🇬🇧 Sheffield, England, United Kingdom