Frank Balis, MD
Children’s Hospital Philadelphia, Philadelphia, PA
Clinical Title: Pilot study to prevent nephrotoxicity of high-dose methotrexate by prolonging the infusion duration and prevent the nephrotoxicity and ototoxicity of cisplatin with pantoprazole in children and adolescents with osteosarcoma
Osteosarcoma is a malignant sarcoma of the bone that afflicts children, adolescents and young adults in the prime of life. Standard therapy includes dose intensive chemotherapy and surgical resection of the primary tumor in bone.
Chemotherapy improves survival to 65% for patients, but comes with substantial and irreversible toxicities. This study investigates a pharmacologically based approach to prevent acute and long-term kidney damage and hearing loss caused by high-dose methotrexate and cisplatin.
Pantoprazole, FDA approved as a proton pump inhibitor, will be incorporated to reduce ototoxicity and nephrotoxicity from cisplatin based on its ability to specifically inhibit transport of cisplatin in the inner ear and renal tubule. Using standard therapy and standard care as backbone, this study potentially helps pediatric patients to cure and achieve that cure with less toxicity.
Status: Active Trial
Accepting Patients? Yes
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