A Phase 1/2 Study of Gemcitabine and Docetaxel in Combination With Hydroxychloroquine (Autophagy Inhibitor) in Patients With Recurrent Osteosarcoma
This phase I/II trial studies the side effects and best dose of hydroxychloroquine and how well it works when given together with gemcitabine and docetaxel in treating participants with osteosarcoma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as gemcitabine, docetaxel, and hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
• Patient or patient's legally acceptable representative has provided informed consent
• Patients must have a pathological diagnosis of osteosarcoma at original diagnosis or time of recurrence
• Patients must have relapsed or become refractory to conventional therapy, with a regimen containing some combination of high dose methotrexate, doxorubicin, cisplatin, and/or ifosfamide
• Patients may have either unresectable or potentially resectable disease. However, patients with potentially resectable disease must be willing to await surgery until after the primary efficacy endpoint is reached at 4 months
• Patients must have measurable disease by RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2. Use Karnofsky for patients \> 16 years old and Lansky for patients =\< 16
• Has archived tumor tissue and is willing to provide a tumor block or unstained slides or the patient is willing to undergo a pretreatment biopsy. Biopsy during cycle #2 of therapy is required. Biopsy at progression is strongly encouraged but will be optional
• Absolute neutrophil count (ANC) \>= 1.0 x 10\^9/L
• Platelet count \>= 100 x 10\^9/L
• Hemoglobin \> 8 g/dL
• Prothrombin time (PT) or partial thromboplastin time (PTT) \< 1.5 x upper limit of normal (ULN), except subjects on anticoagulation for venous thromboembolism
• Calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 60 mL/min
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 x ULN for age
• Total bilirubin \< 1.5 x ULN for age
• Serum albumin \>= 2