National Cancer Institute (NCI)
This phase I/II trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them.
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of DS-8201a in children at least 2 to less than 12 years old with recurrent or refractory WT or DSRCT. (Phase 1) II. To define and describe the toxicities of DS-8201a in children at least 2 to less than 12 years old with recurrent or refractory WT or DSRCT. (Phase 1) III. To estimate the antitumor activity of DS-8201a in pediatric patients and young adults with recurrent or refractory WT. (Phase 2) IV. To estimate the antitumor activity of DS-8201a in pediatric patients and young adults…
Inclusion Criteria: * Phase 1 (Part A): Patients must be at least 2 years and less than 12 years of age at the time of study enrollment * Phase 2: Wilms tumor patients (Part B1): All Wilms tumor patients enrolled must be less than 18 years of age at enrollment * Until the completion of the Phase 1 dose confirmation, patients must be at least 12 years of age and less than 18 years of age at the time of study enrollment * Following dose confirmation of DS-8201a in children at least 2 to less than 12 years old in the Phase 1 component, Wilms tumor patients at least 2 to less than 18 years o…
Undergo blood sample collection
Undergo CT
Undergo echocardiography
Undergo MRI
Undergo MUGA
Given IV