drugset / Trial / NCT02446431

Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence

NCT02446431

NaSingle-groupOpen-labelPrevention

Summary

Most pediatric patients with solid tumors respond to initial high-dose, intensive therapy and complete treatment in remission. High-risk patients however, frequently have recurrent disease which is then treated with ad hoc regimens or early phase therapies with little benefit to the patient. Metronomic therapy (MC), defined as lower dose continuous drug exposure, has been successfully tested in pediatric leukemias with excellent results in terms of improved outcome, toxicity profiles, and cost. MC has been applied to solid tumors with little success, but has been implemented usually in the relapsed setting at a time of high tumor burden and disease resistance.

Timeline

Start
2014-07
Primary completion
2024-07
Completion
2029-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 25 mg/m2 Oral
Subject Temsirolimus Small molecule 25 mg/m2 Intravenous
Subject Valproic Acid Small molecule 5 mg/kg Oral

Indications