Study of Adding Gefitinib, Trametinib, Disulfiram, and Sunitinib to Standard Chemotherapy for Treating Osteosarcoma in Patients Aged 6 to 49 Years

What this Trial Is About

Researchers are evaluating whether adding the drugs gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy improves treatment outcomes for people with osteosarcoma, a type of bone cancer. This Phase 2 study also aims to assess the safety of combining these drugs with chemotherapy and to better understand how osteosarcoma resists treatment by analyzing additional tumor biopsies from participants in one group. The study focuses on patients with high-risk metastatic osteosarcoma, including newly diagnosed and relapsed cases. Participants will receive standard chemotherapy, either MAP chemotherapy or ifosfamide chemotherapy, alongside one or a combination of the study drugs gefitinib, trametinib, disulfiram, or sunitinib. Treatment is given in 6 cycles, each lasting 21 or 28 days depending on the chemotherapy type. A separate group will undergo research biopsies without receiving study drugs. The study includes three cohorts based on diagnosis and disease status, with specific criteria for enrollment. During the study, participants will be monitored for progression-free survival over 12 months or overall survival over 24 months, depending on their cohort. They will undergo research biopsies before and during treatment to study tumor response and resistance. Researchers will assess organ function, performance status, and ability to take oral medications. Participants will be followed closely throughout the treatment cycles with scheduled visits and evaluations, and their safety will be monitored carefully throughout the study period.

A Study of Gefitinib, Trametinib, Disulfiram, and Sunitinib in Addition to Standard Chemotherapy in People With Osteosarcoma