Study of Safety and Response to Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Children and Young Adults with Refractory Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining four treatmentsintravenous atezolizumab, bevacizumab, daily oral cyclophosphamide, and pharmacokinetic-guided sorafenibin children, adolescents, and young adults with relapsed or refractory solid tumors. The study is divided into two parts Part 1 focuses on safety and dosing in various solid tumors, while Part 2 assesses the response rate in fibrolamellar carcinoma FLC and other rare tumors. This phase III trial also explores immune responses and pharmacokinetics related to these drug combinations. Participants receive oral cyclophosphamide daily for 21 days, oral sorafenib twice daily for 21 days with doses adjusted based on blood levels, and intravenous atezolizumab and bevacizumab every three weeks. Part 1 involves determining the maximum tolerated dose and pharmacokinetic targets after one or two treatment cycles. Part 2 uses the recommended doses from Part 1 to further study treatment responses in specific tumor types, with tumor biopsies before treatment and after two cycles to evaluate immune cell changes. Throughout the study, participants undergo regular assessments including tumor biopsies, blood tests, imaging, and monitoring of immune and pharmacokinetic markers. Researchers measure treatment safety, tumor response rates, progression-free survival, and overall survival. Quality of life and family impact are also evaluated through interviews and questionnaires. The total duration varies but includes at least two treatment cycles of 21 days each, with ongoing monitoring for treatment effects and side effects.

Safety and Efficacy of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Pediatric Solid Tumor Patients