Phase I Study of Cabozantinib With High-Dose Ifosfamide in Children and Adults Aged 5 to 40 Years With Relapsed or Refractory Sarcomas

What this Trial Is About

Researchers are evaluating the safety and effectiveness of cabozantinib combined with high-dose ifosfamide in treating children and adults with relapsed or refractory sarcomas. This study focuses on sarcomas that have returned or not responded to previous treatments, aiming to understand if cabozantinib can inhibit specific proteins MET and VEGFR2 involved in tumor growth. The trial is a Phase I study sponsored by the Childrens Hospital of Philadelphia. Participants will receive cabozantinib together with high-dose ifosfamide for five treatment cycles. If participants continue to benefit, they may receive cabozantinib alone for up to a total of twelve cycles. The study includes different age groups divided into two cohorts one for ages 12 to 40 and another for ages 5 to under 12 years. Treatment cycles last 28 days, and the study closely monitors dosing to find the maximum tolerated dose. During the study, participants will have regular assessments including scans to measure tumor response, blood tests to check blood counts and organ function, and evaluations of side effects. Researchers will track toxicities and dose-limiting side effects after each cycle and measure antitumor activity at six months. The primary outcome is to determine the recommended dose for further studies. Participation may last over a year, including safety monitoring and follow-up visits.

Cabozantinib With Ifosfamide in Relapsed/Refractory Sarcomas