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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04616560
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Desmoplastic Small Round Cell Tumor
  • Osteosarcoma
  • Recurrent Desmoplastic Small Round Cell Tumor
  • Recurrent Kidney Wilms Tumor
  • Recurrent Osteosarcoma
  • Refractory Desmoplastic Small Round Cell Tumor
  • Refractory Wilms Tumor
  • Wilms Tumor

Eligibility Criteria

Sex
ALL
Age
12 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Trastuzumab Deruxtecan — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Mar 8, 2021
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (trastuzumab deruxtecan)
    Patients receive trastuzumab deruxtecan IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI, echocardiography or MUGA, blood sample collection throughout the study.

Primary Outcome Measure

Maximum tolerated dose and/or recommended phase 2 dose of DS-8201a in children at least 2 to less than 12 years old with recurrent or refractory Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) (Phase 1) [ Time Frame: During the first cycle of therapy (cycle length = 21 days) ]

Locations (28)

FacilityCityStateZIPSite coordinators
Children's Hospital of AlabamaBirminghamAlabama35233-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Children's Hospital of Orange CountyOrangeCalifornia92868-
Lucile Packard Children's Hospital Stanford UniversityPalo AltoCalifornia94304-
UCSF Medical Center-Mission BaySan FranciscoCalifornia94158-
Children's Hospital ColoradoAuroraColorado80045-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701-
Children's Healthcare of Atlanta - Arthur M Blank HospitalAtlantaGeorgia30329-
Lurie Children's Hospital-ChicagoChicagoIllinois60611-
Riley Hospital for ChildrenIndianapolisIndiana46202-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
C S Mott Children's HospitalAnn ArborMichigan48109-
University of Minnesota/Masonic Cancer CenterMinneapolisMinnesota55455-
Children's Mercy Hospitals and ClinicsKansas CityMissouri64108-
Washington University School of MedicineSt LouisMissouri63110
Site Public Contact
[email protected]
800-600-3606
Shalini Shenoy (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterNew YorkNew York10032-
Duke University Medical CenterDurhamNorth Carolina27710-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224-
Saint Jude Children's Research HospitalMemphisTennessee38105
Site Public Contact
[email protected]
888-226-4343
Jessica Gartrell (PRINCIPAL_INVESTIGATOR)
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232-
UT Southwestern/Simmons Cancer Center-DallasDallasTexas75390-
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHoustonTexas77030-
Primary Children's HospitalSalt Lake CityUtah84113-

Find similar trials in Birmingham, AL

By research site
Children's Hospital of Alabama· Birmingham, ALChildren's Hospital Los Angeles· Los Angeles, CAChildren's Hospital of Orange County· Orange, CALucile Packard Children's Hospital Stanford University· Palo Alto, CAUCSF Medical Center-Mission Bay· San Francisco, CAChildren's Hospital Colorado· Aurora, CO

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