What this Trial Is About

Researchers are investigating a treatment regimen called VIT, which combines irinotecan, temozolomide, and vincristine, for children with relapsed and refractory solid tumors who have a wild-type UGT1A1 gene. Irinotecan is a common chemotherapy drug but can cause dose-limiting side effects like abdominal pain and diarrhea, especially in patients with certain gene mutations. This study focuses on whether increasing irinotecan doses in patients without these mutations can improve treatment effectiveness and safety in a Phase I clinical trial setting. In this study, temozolomide and vincristine doses remain fixed while irinotecan doses start at 50 mg/m² and increase through five groups, reaching up to 110 mg/m². The goal is to find the maximum dose patients can tolerate and assess the safety of higher irinotecan doses when combined in the VIT regimen. The study also evaluates important treatment outcomes like response rates, disease control, progression-free survival, and overall survival to help guide future clinical trials. Participants are children under 18 years with relapsed or refractory solid tumors and a confirmed wild-type UGT1A1 gene. They will receive outpatient treatment and undergo regular lab tests, clinical visits, and monitoring for side effects. Researchers will measure dose-limiting toxicities and track treatment responses from the start of the regimen through 16 days after its completion. This thorough follow-up ensures patient safety while gathering key data on the treatment's potential benefits and risks.

UGT1A1 Genotype-drien Phase I Study of Irinotecan in VIT Regimen for the Treatment of Pediatric R/R Solid Tumors