Combination Chemotherapy Followed by Surgery and Peripheral Stem Cell or Bone Marrow Transplantation in Treating Infants With Newly Diagnosed Neuroblastoma
NCT ID: NCT00025649
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 given before surgery followed by peripheral stem cell or bone marrow transplantation in treating infants who have newly diagnosed neuroblastoma.
Detailed Description
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* Determine the survival of infants with newly diagnosed stage II, III, IV, or IVS neuroblastoma with MYCN amplification treated with etoposide, carboplatin, cyclophosphamide, doxorubicin, and vincristine followed by surgery and busulfan and melphalan with autologous peripheral blood stem cell or bone marrow transplantation.
* Determine whether there are 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 then 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.
Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days. Patients undergo leukapheresis to collect peripheral blood stem cells (PBSC). Patients who do not mobilize sufficient cells undergo bone marrow harvest.
Patients eligible for surgery undergo surgical resection. Patients with stage IV disease with less than complete response of metastatic disease after initial chemotherapy are removed from the study.
Beginning within 2 weeks after surgery, patients receive 1 additional course of VP-CARBO chemotherapy followed by 1 additional course of CADO chemotherapy.
After at least 3 weeks, patients receive high-dose chemotherapy comprising busulfan IV over 24 hours on days -7 to -3 and melphalan IV on day -2. PBSC or bone marrow are reinfused on day 0.
At least 2 months after the completion of high-dose chemotherapy and bone marrow or PBSC transplantation, patients undergo radiotherapy to the primary site, according to preoperative imaging studies. Patients are treated with oral tretinoin after megatherapy.
Patients are followed within 6 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 40 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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filgrastim
busulfan
carboplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
melphalan
vincristine sulfate
autologous bone marrow transplantation
conventional surgery
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed newly diagnosed stage II, III, IV, or IVS neuroblastoma or ganglioneuroblastoma
* MYCN amplification (i.e., at least 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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Adela Canete, MD, PhD
Role: STUDY_CHAIR
Hospital Universitario La Fe
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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Canete A, Gerrard M, Rubie H, Castel V, Di Cataldo A, Munzer C, Ladenstein R, Brichard B, Bermudez JD, Couturier J, de Bernardi B, Pearson AJ, Michon J. Poor survival for infants with MYCN-amplified metastatic neuroblastoma despite intensified treatment: the International Society of Paediatric Oncology European Neuroblastoma Experience. J Clin Oncol. 2009 Mar 1;27(7):1014-9. doi: 10.1200/JCO.2007.14.5839. Epub 2009 Jan 26.
Other Identifiers
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EURO-INF-NB-STUDY-1999-99.4
Identifier Type: -
Identifier Source: secondary_id
EU-20125D
Identifier Type: -
Identifier Source: secondary_id
CDR0000068982
Identifier Type: -
Identifier Source: org_study_id