Neuroblastoma Clinical Trial
Official title:
A Study Of The Treatment Of Metastatic Neuroblastoma In Children More Than One Year Of Age At Diagnosis
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.
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.
;
Primary Purpose: Treatment
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