A Phase 2 interventional study of carboplatin and cyclophosphamide in Neuroblastoma, sponsored by European Infant Neuroblastoma Study Group - 1999. Completed at 11 sites in 11 countries. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2013-09-17.
Sponsored by European Infant Neuroblastoma Study Group - 1999 · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them before surgery, may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by surgery in treating infants who have newly diagnosed neuroblastoma.
OBJECTIVES:
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 without disease progression receive 2 additional courses of VP-CARBO chemotherapy. Patients with metastatic complete response (CR) undergo surgical resection of primary disease.
Patients with disease progression after 2 or 4 courses of VP-CARBO chemotherapy 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.
After 2 courses of CADO chemotherapy, patients with metastatic CR undergo surgical resection of primary disease. Patients with residual disease receive 2 additional courses of CADO chemotherapy. Patients with residual disease after 4 courses of CADO chemotherapy are removed from the study. Patients with metastatic CR after additional CADO chemotherapy undergo surgical resection of primary disease.
Patients are followed within 6 months and then annually for 5 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 4 years.
625 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.
Browse Neuroblastoma studies →European Infant Neuroblastoma Study Group - 1999 is the lead sponsor of 4 studies on the registry; none are open to participants now.
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DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed stage IV neuroblastoma or ganglioneuroblastoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
This study is completed, as verified in Dec 2002. You cannot join it, but the record below documents what was studied.
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European Infant Neuroblastoma Study Group - 1999