Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan

Sponsor
Washington University School of Medicine
Study ID
NCT02747537
Phase
PHASE2
Status
Withdrawn

Conditions

  • Pediatric Solid Tumors

Eligibility Criteria

Sex
ALL
Age
24 Months - 21 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 24, 2016
Status verified
Sep 2019
Primary completion
Jan 31, 2020
Completion
Feb 29, 2020

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Sorafenib and Irinotecan
    * Sorafenib is an oral drug which will be administered on an outpatient basis twice a day continuously (every day of a 21-day cycle) at approximately the same times each day. For patients unable to swallow whole pills, an oral suspension may be prepared with tablets. * Irinotecan will be administered orally (mixed with "cranberry" type juice) on an outpatient basis once a day on Days 1-5 of a 21-day cycle. Irinotecan should be given at least 1 hour after sorafenib.

Primary Outcome Measure

Overall response rate [ Time Frame: Completion of treatment (18 weeks) ]

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