Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma.
NCT ID: NCT00025597
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
2011-02-28
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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* Determine the survival and morbidity of infants with newly diagnosed stage II or III unresectable neuroblastoma without MYCN amplification treated with vincristine and cyclophosphamide, etoposide and carboplatin, and cyclophosphamide, doxorubicin, and vincristine followed by surgery.
* 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 symptomatic spinal cord involvement (yes vs no).
Patients without evidence of symptomatic spinal cord compression receive vincristine IV on day 1 and cyclophosphamide IV on days 1-5. Treatment repeats every 14 days for 2 courses. Patients eligible for surgery undergo surgical resection and then are removed from the study.
Patients ineligible for surgery after 2 courses of initial chemotherapy, but with at least 25% response to initial chemotherapy, receive 2 additional courses of vincristine and cyclophosphamide. Patients eligible for surgery undergo surgical resection and then are removed from the study.
Patients ineligible for surgery after 2 additional courses of initial chemotherapy or with disease progression 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 eligible for surgery undergo surgical resection and then are removed from the study.
Patients who remain ineligible for surgery or with disease progression after etoposide and carboplatin 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 2 courses. Patients then undergo surgical resection or biopsy.
Patients with symptomatic spinal cord compression receive initial treatment with etoposide and carboplatin as above. Patients with improved symptoms and resectable disease after initial chemotherapy undergo surgical resection or biopsy. Patients who remain ineligible for surgery or with no improvement in symptoms after initial chemotherapy receive cyclophosphamide, doxorubicin, and vincristine as above. Patients then undergo surgical resection or biopsy.
Patients are followed within 6 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 100 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 or cytologically confirmed newly diagnosed stage II or III neuroblastoma or ganglioneuroblastoma
* Unresectable disease
* No MYCN amplification (i.e., fewer than 10 copies)
* No metastases to bone marrow
* No radiological bone lesions in skeleton
PATIENT CHARACTERISTICS:
Age:
* Under 12 months at diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* No evidence of liver disease by ultrasound
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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Herve Rubie, MD
Role: STUDY_CHAIR
Centre Hospitalier Regional de Purpan
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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Rubie H, De Bernardi B, Gerrard M, Canete A, Ladenstein R, Couturier J, Ambros P, Munzer C, Pearson AD, Garaventa A, Brock P, Castel V, Valteau-Couanet D, Holmes K, Di Cataldo A, Brichard B, Mosseri V, Marquez C, Plantaz D, Boni L, Michon J. Excellent outcome with reduced treatment in infants with nonmetastatic and unresectable neuroblastoma without MYCN amplification: results of the prospective INES 99.1. J Clin Oncol. 2011 Feb 1;29(4):449-55. doi: 10.1200/JCO.2010.29.5196. Epub 2010 Dec 20.
Other Identifiers
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EURO-INF-NB-STUDY-1999-99.1
Identifier Type: -
Identifier Source: secondary_id
EU-20125A
Identifier Type: -
Identifier Source: secondary_id
CDR0000068977
Identifier Type: -
Identifier Source: org_study_id