Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma
NCT ID: NCT00025623
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-07-31
2009-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
vincristine sulfate
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
1 Year
ALL
No
Sponsors
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European Infant Neuroblastoma Study Group - 1999
OTHER
Principal Investigators
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Bruno De Bernardi, MD
Role: STUDY_CHAIR
Istituto Giannina Gaslini
Locations
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St. Anna Children's Hospital
Vienna, , Austria
Universitair Ziekenhuis Gent
Ghent, , Belgium
Rigshospitalet
Copenhagen, , Denmark
Centre Hospitalier Regional de Purpan
Toulouse, , France
Istituto Giannina Gaslini
Genoa, , Italy
Rikshospitalet University Hospital
Oslo, , Norway
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.
Lisbon, , Portugal
Hospital Universitario LA FE
Valencia, , Spain
Ostra Sjukhuset
Gothenburg, , Sweden
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Countries
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References
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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.
Other Identifiers
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EURO-INF-NB-STUDY-1999-99.3
Identifier Type: -
Identifier Source: secondary_id
EU-20125C
Identifier Type: -
Identifier Source: secondary_id
CDR0000068980
Identifier Type: -
Identifier Source: org_study_id