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

Phase 2

Completed

• Conditions: Neuroblastoma

• Registration Number: NCT00025623
• 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, 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.

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.

Study Timeline

• Study Start: 1999-07
• Study First Submitted: 2001-10-11
• Status Verified: 2002-12
• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (11)

Rikshospitalet University Hospital; 🇳🇴 Oslo, Norway

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Centre Hospitalier Regional de Purpan; 🇫🇷 Toulouse, France

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

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Hospital Universitario LA FE; 🇪🇸 Valencia, Spain

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

Ostra Sjukhuset; 🇸🇪 Gothenburg, Sweden

Istituto Giannina Gaslini; 🇮🇹 Genoa, Italy

Universitair Ziekenhuis Gent; 🇧🇪 Ghent, Belgium

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