Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma

The phase I portion of this study is designed for children or adolescents and young adults (AYA) with a diagnosis of a solid tumor that has recurred (come back after treatment) or is refractory (never completely went away). The trial will test 2 combinations of therapy and participants will be randomly assigned to either Arm A or Arm B. The purpose of the phase I study is to determine the highest tolerable doses of the combinations of treatment given in each Arm. In Arm A, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and talazoparib. On

Trial Details

NCT ID

NCT04901702

Phase

PHASE1 / PHASE2

Sponsor

St. Jude Children's Research Hospital

Status

RECRUITING

Cancer Type

Kidney Cancer

Interventions

Onivyde
Talazoparib
Temozolomide

Locations (sample)

Palo Alto, California, United States|37.44188,-122.14302
Aurora, Colorado, United States|39.72943,-104.83192
Washington D.C., District of Columbia, United States|38.89511,-77.03637
Atlanta, Georgia, United States|33.749,-84.38798
Minneapolis, Minnesota, United States|44.97997,-93.26384

Key Eligibility Criteria

Patients must be \> 12 months and \< 30 years at the time of enrollment on study.
Patients with refractory or recurrent non-central nervous system (CNS) solid tumors not amenable to curative treatment are eligible. Patients must …
Patients with refractory or recurrent Ewing sarcoma (during or after completion of first-line therapy). Refractory disease is defined as progressio…
Patients must have a histologic diagnosis of Ewing sarcoma with EWSR1- FLI1 translocation or other EWS rearrangement at the time of initial diagnos…

For full eligibility, visit ClinicalTrials.gov.

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