Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor (NCT04616560)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Phase 1 (Part A): Patients must be at least 2 years and less than 12 years of age at the time of study enrollment
2. Phase 2: Wilms tumor patients (Part B1): All Wilms tumor patients enrolled must be less than 18 years of age at enrollment
3. 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
4. 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
5. Phase 2: DSRCT patients (Part B2): Until the completion of the Phase 1 component, patients enrolling on the Phase 2 component of the study must be from at least 12 to 39 years of age at the time of study enrollment
6. Following dose confirmation of DS-8201a in children at least 2 to less than 12 years old in the Phase 1 component, DSRCT patients at least 2 to 39 years of age will be allowed on the Phase 2 component
7. Patients must have had histologic verification of Wilms tumor or desmoplastic small round cell tumor at original diagnosis or relapse
8. Solid tumors: Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients with clinically inactive brain metastases may be included in the study. Patients with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Lastly, patient must have unresectable lesions or lesions with no intention to surgically remove the lesions in the 6 months following enrollment
9. Wilms tumor: WT patients must have either refractory disease or a very high risk relapse, defined as ANY of the following:
10. Relapse after initial treatment with 4 or more chemotherapy agents (e.g. Regimens vincristine, dactinomycin, doxorubicin, cyclophosphamide, etoposide and radiation \[M\], vincristine, dactinomycin and doxorubicin, vincristine, and irinotecan \[MVI\], doxorubicin, vincristine, cyclophosphamide, carboplatin, etoposide and radiation \[UH-1\], doxorubicin, vincristine, cyclophosphamide, carboplatin, etoposide, vincristine, and irinotecan \[UH-2\], vincristine, irinotecan, cyclophosphamide, carboplatin, etoposide and doxorubicin \[UH-3\], and etoposide, carboplatin, cyclophosphamide, and doxorubicin \[HR-1\])
11. Relapse with high risk histology (anaplasia, blastemal predominant)
12. Multiple relapses

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (29 Sites)

• Children's Hospital of Alabama — Birmingham, Alabama
• Children's Hospital Los Angeles — Los Angeles, California
• Children's Hospital of Orange County — Orange, California
• Lucile Packard Children's Hospital Stanford University — Palo Alto, California
• UCSF Medical Center-Mission Bay — San Francisco, California
• Children's Hospital Colorado — Aurora, Colorado
• Children's National Medical Center — Washington D.C., District of Columbia
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida
• Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia
• Lurie Children's Hospital-Chicago — Chicago, Illinois
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois
• Riley Hospital for Children — Indianapolis, Indiana
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
• Dana-Farber Cancer Institute — Boston, Massachusetts
• C S Mott Children's Hospital — Ann Arbor, Michigan
• University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota
• Children's Mercy Hospitals and Clinics — Kansas City, Missouri
• Washington University School of Medicine — St Louis, Missouri
• NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York, New York
• Memorial Sloan Kettering Cancer Center — New York, New York
• Duke University Medical Center — Durham, North Carolina
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania
• Saint Jude Children's Research Hospital — Memphis, Tennessee

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.