Chemotherapy and Surgery Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Neuroblastoma
NCT ID: NCT00024193
Last Updated: 2013-08-07
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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UNKNOWN
PHASE2
INTERVENTIONAL
1999-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation in treating patients who have metastatic neuroblastoma.
Detailed Description
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* Determine the efficacy of induction chemotherapy followed by surgical resection and consolidation chemotherapy with autologous peripheral blood stem cell transplantation in patients with metastatic neuroblastoma.
* Determine the tolerability and feasibility of this regimen in these patients.
* Determine the medium and long-term results in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising cyclophosphamide IV over 6 hours on days 1 and 2 and doxorubicin IV continuously and vincristine IV continuously over days 1-3 of courses 1, 2, 4, and 6. Patients receive cisplatin IV over 1 hour on days 1-4 and etoposide IV over 2 hours on days 1-3 of induction courses 3, 5, and 7. Patients also receive filgrastim (G-CSF) IV or subcutaneously once daily beginning on day 5 of courses 3, 5, and 7 and continuing until blood counts recover. Treatment repeats every 21 days.
At the completion of induction chemotherapy, patients undergo surgical resection. Patients in complete remission receive high-dose consolidation chemotherapy comprising oral busulfan every 6 hours on days -7 to -3 and melphalan IV over 2 minutes on day -2. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0. Patients with n-myc tumor amplification undergo radiotherapy at least 70 days after PBSC transplantation.
Patients are followed every 6 months.
PROJECTED ACCRUAL: Approximately 15-45 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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filgrastim
busulfan
cisplatin
cyclophosphamide
doxorubicin hydrochloride
etoposide
melphalan
vincristine sulfate
conventional surgery
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed primary neuroblastoma OR
* Presence of neuroblasts in bone marrow associated with an elevation of urinary catecholamines
* Metastatic disease demonstrated by at least 1 of the following:
* Medullary invasion (bone marrow involvement) as indicated by bone uptake on meta-iodobenzyl guanidine I 123 or bone lesions on bone scan
* Distant metastases to liver, pleura, lungs, or distant nodes
* No 11-22 translocation
PATIENT CHARACTERISTICS:
Age:
* 1 and over
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* See Disease Characteristics
Other:
* No contraindications to study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
1 Year
ALL
No
Sponsors
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Societe Francaise Oncologie Pediatrique
OTHER
Children's Cancer and Leukaemia Group
OTHER
Principal Investigators
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Janice A. Kohler, MD, FRCP
Role: STUDY_CHAIR
University Hospital Southampton NHS Foundation Trust
D. Valteau-Couanet
Role: STUDY_CHAIR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Institut Gustave Roussy
Villejuif, , France
Countries
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Other Identifiers
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CDR0000068899
Identifier Type: REGISTRY
Identifier Source: secondary_id
SFOP-NB97
Identifier Type: -
Identifier Source: secondary_id
EU-20106
Identifier Type: -
Identifier Source: secondary_id
CCLG-NB-1999-02
Identifier Type: -
Identifier Source: org_study_id