Health Trials

Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Newly Diagnosed, Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor

ConditionsDesmoplastic Small Round Cell TumorOsteosarcomaRecurrent Desmoplastic Small Round Cell TumorRecurrent Kidney Wilms TumorRecurrent OsteosarcomaRefractory Desmoplastic Small Round Cell TumorRefractory Wilms TumorWilms Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12-39
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

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 of age will be allowed on the Phase 2 component

Disqualifiers

Pregnant, planning to become pregnant, or breast-feeding women will not be entered on this study. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Abstinence is an acceptable method of birth control

Oral

Intravaginal

Transdermal

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography Test
  • Magnetic Resonance Imaging
  • Multigated Acquisition Scan
  • Trastuzumab Deruxtecan

Treatment groups

55 Participants
are divided into 1 treatment group

Locations

28
Alabama
Children's Hospital of Alabama35233, Birmingham United States
California
Children's Hospital Los Angeles90027, Los Angeles United States
Children's Hospital of Orange County92868, Orange United States
Lucile Packard Children's Hospital Stanford University94304, Palo Alto United States

Sponsors and collaborators

National Cancer Institute (NCI)

Lead sponsor

Source ClinicalTrials.gov