Combination Chemotherapy in Treating Infants With Newly Diagnosed Neuroblastoma
NCT ID: NCT00025610
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 different combination chemotherapy regimens in treating infants who have newly diagnosed neuroblastoma.
Detailed Description
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* 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.
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
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed newly diagnosed stage IV or IVS neuroblastoma or ganglioneuroblastoma
* Metastases confined to marrow, skin, nodes, or liver
* No metastases to bone (radiologic bone lesions in skeleton), CNS, pleura, or lung
* 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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Mary P. Gerrard, MBChB, FRCP, FRCPCH
Role: STUDY_CHAIR
Children's Hospital - Sheffield
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
Children's Hospital - Sheffield
Sheffield, 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-1999-99.2
Identifier Type: -
Identifier Source: secondary_id
EU-20125B
Identifier Type: -
Identifier Source: secondary_id
CDR0000068979
Identifier Type: -
Identifier Source: org_study_id