drugset / Trial / NCT02446431
Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of Recurrence
Phase 0
Recruiting
20 enrolled
Miller Children's & Women's Hospital Long Beach
Children's Hospital of Orange County · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |