Condition: Recurrent Solid Tumor · Recurrent Ewing Sarcoma · Recurrent Hepatoblastoma · Sponsor: St. Jude Children's Research Hospital
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. Onivyde works by damaging the DNA of the cancer cell and talazoparib works by blocking the repair of the DNA once the cancer cell is damaged. By damaging the tumor DNA and blocking the repair, the cancer cells may die. In Arm B, children and AYAs with recurrent or refractory solid tumors will receive 2 medications called Onivyde and temozolomide. Both of these medications work by damaging the DNA of the cancer call which may cause the tumor(s) to die. Once the highest doses are reached in Arm A and Arm B, then "expansion Arms" will open. An expansion arm treats more children and AYAs with recurrent or refractory solid tumors at the highest doses achieved in the phase I study. The goal of the expansion arms is to see if the tumors go away in children and AYAs with recurrent or refractory solid tumors. There will be 3 "expansion Arms". In Arm A1, children and AYAs with recurrent or refracto…
This description comes directly from the study's public registry record.
Sara Federico, MD · 888-226-4343 · referralinfo@stjude.org
Always discuss trial participation with your own doctor first.
| Lucille Packard Children's Hospital Stanford | Palo Alto, California, United States | Recruiting |
| Children's Hospital Colorado | Aurora, Colorado, United States | Recruiting |
| Children's National Medical Center | Washington D.C., District of Columbia, United States | Recruiting |
| Children's Healthcare of Atlanta/Emory University School of Medicine | Atlanta, Georgia, United States | Recruiting |
| Children's Hospital and Clinics of Minn | Minneapolis, Minnesota, United States | Recruiting |
| St. Jude Children's Research Hospital | Memphis, Tennessee, United States | Recruiting |
| Texas Children's Hospital/ Baylor College of Medicine | Houston, Texas, United States | Active Not Recruiting |
| The Hospital for Sick Children | Toronto, Ontario, Canada | Recruiting |
| CHU Sainte-Justine | Montreal, Canada | Recruiting |
| BC Children's Hospital Research Institute | Vancouver, Canada | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT04901702