Memorial Sloan Kettering Cancer Center
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.
Inclusion Criteria: Cohort 1 only: Newly Diagnosed, Metastatic Osteosarcoma 1. For study entry, the suspected diagnosis of osteosarcoma may be based on clinical judgement. Biopsy confirmation is required for treatment but as this protocol has biologic aims from serial tumor samples, some patients will be enrolled prior to open biopsy. Patients must have a histologic new diagnosis of metastatic high-risk osteosarcoma to start OstEvo systemic therapy. For purposes of this protocol, newly diagnosed, high-risk metastatic osteosarcoma includes: 1. Having at least 1 extrapulmonary metastasis,…
Methotrexate 12 g/m\^2 (max dose 20 grams) intravenously over 4 hours or as per institutional standard.
Doxorubicin 37.5 mg/m\^2 intravenously over 15 to 30 minutes or as per institutional standard.
Cisplatin 60 mg/m\^2 intravenously over 4 hours or as per institutional standard.
Gefitinib 400 mg/m\^2/dose (maximum dose 250 mg) orally daily for 14 days (14 doses)
Trametinib will be dispensed as per institutional standard.
Disulfiram 250 to 500 mg orally once daily for 14 days
Sunitinib capsules for under 18 years of age: 15 mg/m\^2/dose (maximum 50 mg) orally once daily x 14 days
Ifosfamide 2,800 mg/m\^2 intravenously as per institutional standard.
Research biopsy prior to therapy