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Chemotherapy and Surgery Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Neuroblastoma

A Study Of The Treatment Of Metastatic Neuroblastoma In Children More Than One Year Of Age At Diagnosis

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00024193
Enrollment
Unknown
Registered
2003-01-27
Start date
1999-04-30
Completion date
Unknown
Last updated
2013-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroblastoma

Keywords

stage 4S neuroblastoma

Brief summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells. Chemotherapy, given before and after surgery, followed by peripheral stem cell transplantation may be an effective treatment for metastatic neuroblastoma. 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

OBJECTIVES: * 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.

Interventions

BIOLOGICALfilgrastim
DRUGbusulfan
DRUGcisplatin
DRUGcyclophosphamide
DRUGdoxorubicin hydrochloride
DRUGetoposide
DRUGmelphalan
DRUGvincristine sulfate
PROCEDUREconventional surgery
PROCEDUREperipheral blood stem cell transplantation

Sponsors

Societe Francaise Oncologie Pediatrique
CollaboratorOTHER
Children's Cancer and Leukaemia Group
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026