The researchers are doing this study to find out whether adding gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy is a more effective treatment approach for people with osteosarcoma than standard chemotherapy on its own. The researchers will also look at the safety of adding these drugs to standard chemotherapy. The researchers will also use the additional research biopsies from Cohort 1 participants to learn more about how osteosarcoma survives during chemotherapy.
Having at least 1 extrapulmonary metastasis, radiographic confirmation of metastasis is adequate, and/or
Unresectable metastases at diagnosis as determined by the investigator
Patients may have started systemic conventional chemotherapy but must enroll on this study prior to day 29 of chemotherapy initiation. Having received a single standard MAP cycle (AP x 1 and HDMTX up to 2 times) of chemotherapy prior to enrollment is acceptable
Patients with newly diagnosed osteosarcoma who are not eligible for Cohorts 1 or 2.
Patients who are receiving any other investigational agents for osteosarcoma therapy are ineligible.
Patient with an uncontrolled chronic or active infection or another condition where any component of OstEvo therapy would be contraindicated.
Patients with a history of heart disease including, but not limited to: uncontrolled hypertension within 12 months prior to enrollment; ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade; unstable angina, symptomatic congestive heart failure, or prior myocardial infarction.
Patients must not be receiving any additional medicines being given for the specific purpose of treating cancer. Alternative medications including, but not limited to cannabis-based products would not be a reason for exclusion.