Sirolimus With Cyclophosphamide and Topotecan for Pediatric/Adolescent Relapsed and Refractory Solid Tumors
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
This is a Phase I study of the combination of three drugs: sirolimus, cyclophosphamide, and
topotecan. This is the first study to evaluate the safety and clinical activity of the
combination of oral sirolimus, oral cyclophosphamide and oral topotecan in pediatric and
young adult patients with relapsed and refractory solid tumors.
In this phase I study, the mTOR inhibitor sirolimus will be administered in combination with
oral cyclophosphamide and oral topotecan to children with relapsed or refractory solid
tumors. The primary aim of this study is to recommend a phase II dose schedule and describe
the toxicity of this combination. Myelosuppression will be a targeted toxicity.