UT Southwestern Medical Center (UTSW), along with Children’s Health, will lead the Phase l VITAS trial of Atezolizumab immunotherapy in combination with three chemotherapy agents to treat children with solid tumours that have recurred or shown no significant response following initial treatment.
Pauline Allen Gill Center for Cancer and Blood Disorders at Children’s Medical Center Dallas is the first clinical site to open for the trial.
Expected to be completed by January 2025, the study will enrol six patients with solid tumours who did not respond to initial treatment.
Based on the success of the trial, the researchers plan to proceed with a Phase ll trial to examine the efficacy of the combination therapy in 17 children with relapsed or refractory rhabdomyosarcoma, the most prevalent soft tissue sarcoma in children.
The trial will proceed to Phase II, based on the safety of the combined therapy in terms of dose-limiting toxicity in not more than two of the six patients.
The proposed Phase ll trial aims to observe a response to treatment in at least half of the 17 patients.
Other findings from the trial could help researchers to determine the kinds of patients benefitting most from this type of combined therapy and comprehend the molecular mechanisms involved.
The combined treatment already showed promising results in adults, according to the researchers of the trial.
Children’s Health paediatric haematologist/oncologist and UTSW Paediatrics assistant professor Matthew Campbell said: “We know that a patient’s immune system will try to fight cancer cells, but often it loses.
“By enhancing immunotherapy with chemotherapy, a strategy we’ve seen succeed in clinical trials for adults with cancer, we’re hoping to see the same success in children.”
The trial involves the participation of Dana-Farber Cancer Institute, Children’s Hospital of Philadelphia, Cincinnati Children’s Hospital Medical Center, and Seattle Children’s Hospital, among others.