Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan
Status:
Withdrawn
Trial end date:
2020-02-29
Target enrollment:
Participant gender:
Summary
This study proposes to treat patients with the combination of sorafenib and irinotecan.
Patients with relapsed, recurrent, refractory, or high risk malignancies whose tumors possess
a non-synonymous mutation in Raf, PDGFR, VEGFR, Flt-3, KIT, JAK, STAT, RAS, MEK, or ERK will
be eligible for the study. Very few phase 2 clinical trials have been performed in pediatrics
using targeted agents in combination with conventional chemotherapy agents. Furthermore,
since some combinations such as the combination of this study (sorafenib and irinotecan) have
shown additive/synergistic effects in preclinical studies, therapy selecting for those
patients who possess mutations targeted by the TKI of the study, may unveil activity that has
not been previously observed. Thus, the investigators hope to determine whether the addition
of additive/synergistic chemotherapy will increase efficacy of the targeted agent and/or
increase tumor susceptibility to the targeted agent, resulting in increased anti-tumor
activity.