Phase 2: testing Trastuzumab Deruxtecan for Desmoplastic Small Round Cell Tumor
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.
Official registry: https://clinicaltrials.gov/study/NCT04616560 · National Cancer Institute (NCI) · enrollment listed as 55
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Echocardiography Test. The registry lists allocation as na. 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).
They plan to enroll about 55 people at 32 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.
Official title (unrewritten)
A Phase 1/2 Study of DS-8201a (NSC# 807708) in Children, Adolescents, or Young Adults With Recurrent Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor
Interventions: Biospecimen Collection, Computed Tomography, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan, Trastuzumab Deruxtecan
Primary outcome (registry wording): 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)
Who it is for (from inclusion criteria)
- Ages 12 Years to 39 Years
- 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
- 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
- Patients must have had histologic verification of Wilms tumor or desmoplastic small round cell tumor at original diagnosis or relapse
- Wilms tumor: WT patients must have either refractory disease or a very high risk relapse, defined as ANY of the following:
Who the registry excludes
- Methods considered as highly effective methods of contraception include:
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner
Contact
No central phone on the registry card. Use the official listing to reach a site.
Sites listed on ClinicalTrials.gov
32 listed- Children's Hospital of Alabama — Birmingham, Alabama (suspended)
- Children's Hospital Los Angeles — Los Angeles, California (recruiting)
- Children's Hospital of Orange County — Orange, California (suspended)
- Lucile Packard Children's Hospital Stanford University — Palo Alto, California (recruiting)
- UCSF Medical Center-Mission Bay — San Francisco, California (suspended)
- Children's Hospital Colorado — Aurora, Colorado (suspended)
- Children's National Medical Center — Washington D.C., District of Columbia (recruiting)
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida (recruiting)
- Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia (recruiting)
- Lurie Children's Hospital-Chicago — Chicago, Illinois (suspended)
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois (recruiting)
- Riley Hospital for Children — Indianapolis, Indiana (suspended)
FAQ about this NCT record
Is NCT04616560 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT04616560?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT04616560?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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