A pediatric phase II trial- SMHOP-metro01- set in collaboration between the Société Marocaine d’Hématologie et Oncologie Pédiatrique and the Metronomic Global Health Initiative, for children with advanced or relapse disease has been launched in Morocco.
The study will be piloted by Pr. Maria El Kababri with the support of Pr Laila Hessissen, and Pr Mhamed Harif.
The study is supported by the Fondation Lalla Salma and Gauthier Bouche from the AntiCancer Fund (previously Reliable Therapies) is helping us finding other sources of funding.
The metronomic regimen will consist in :
Cyclophosphamide : 30 mg/m2/day for 3 weeks followed by a one week break
VP16 : 25 mg/m²/day for 3 weeks followed by a one week break
Valroic acid 20 mg/kg/day everyday without break
200 patients will be recruited in 10 groups of patients (group 1 to 5 : relapsed patients groups 6 to 10 : advanced disease/frail patients) according to the underlying disease Neuroblatoma & nephroblastoma - sarcoma of the bone - soft tissue sarcoma - Leukemia- miscelenaous). This is a one step phase II according to the Flemming design.