METRO NB2012
Phase II trial of metronomic treatment in children and adolescents with recurrent or progressive neuroblastoma (METRO-NB2012)
Recruitment completed
Summary
Neuroblastoma is the second most frequent cause for death from cancer in childhood. Already one year after diagnosis of recurrence from high risk neuroblastoma, 75% of the patients experience further progression.
Metronomic therapy is targeting not only the tumor cell, but also the tumor supplying vasculature and the interactions between tumor and immune cells. The toxicity is expected to be low due to the low (but continuous) dosing of drugs.
The study investigates the tolerance and the efficacy of a new combination of five drugs consisting of propranolol (antiangiogenetic, anti-neuroblastic), Celecoxib (modulating immune response, ant-neuroblastic), cyclophosphamide (antiangiogenetic, anti-neuroblastic), etoposide (antiangiogenetic, anti-neuroblastic), and vinblastin (antiangiogenetic, anti-neuroblastic). Vinblastin is scheduled every 14 days intravenously, all other drugs are applied daily throughout 365 days (except etoposide for 4x3 weeks). All drugs have been used in children for other conditions. From those experiences low toxicities and a favorable Quality of life are expected.
Main inclusion criteria
- Newly diagnosed recurrence or progression of high risk neuroblastoma which progressed despite previous treatment
- Children, adolescents, young , adults (2 - 20 years)
Sponsor
University of Cologne