This phase II trial studies how well high-dose, or myeloablative, chemotherapy and stem cell transplant works in treating patients with neuroblastoma that is at high risk of spreading. Myeloablative chemotherapy uses high doses of chemotherapy to kill cells in the bone marrow, both cancer cells and healthy cells. Healthy stem cells from the patient that were collected before chemotherapy are then returned to the patient in a stem cell transplant to replace the cells that were killed by chemotherapy. Myeloablative chemotherapy and stem cell transplant may be an effective treatment for patients with high-risk neuroblastoma.
Additional locations may be listed on ClinicalTrials.gov for NCT02605421.
Locations matching your search criteria
United States
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer CenterStatus: Active
Contact: Ashish Gupta
PRIMARY OBJECTIVE:
I. To evaluate 3 year progression free survival (PFS) rate of high-risk neuroblastoma patients after treatment with a tandem consolidation of thiotepa/cyclophosphamide and peripheral blood stem cell (PBSC) rescue followed by carboplatin/etoposide/melphalan (CEM) and PBSC rescue, as compared to historical controls of a single CEM consolidation course with PBSC rescue.
SECONDARY OBJECTIVE:
I. To determine key transplant outcomes as tracked by the departmental bone marrow transplant (BMT) database including time to engraftment, relapse, and overall survival.
OUTLINE:
CONSOLIDATION COURSE 1: Patients receive thiotepa intravenously (IV) over 2 hours on days -7 to -5 and cyclophosphamide IV over 1 hour and mesna IV over 15 minutes on days -5 -to -2.
CONSOLIDATION COURSE 2: Patients with no clinical evidence of disease progression begin course 2 within 6-10 weeks from day 0 of course 1. Patients receive melphalan IV over 15-30 minutes on days -8 to -6 and etoposide IV over 24 hours and carboplatin IV over 24 hours on days -8 to -5. It is permissible to move the start of the first melphalan infusion up 2-4 hours (to be given on day -8) immediately followed by the etoposide/carboplatin infusion to accommodate for late night drug preparation and administration.
AUTOLOGOUS STEM CELL INFUSION: On day 0 of each consolidation course, patients receive an autologous PBSC infusion over 15-60 minutes.
After completion of study treatment, patients are followed up at 3, 6, 9, 12, 18, 24, 30, and 36 months.
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorAshish Gupta