Study on Using Sodium Thiosulfate to Reduce Hearing Loss in Medulloblastoma Treatment

Program Overview

This study is testing if adding sodium thiosulfate (STS) to the usual treatment for medulloblastoma can help reduce hearing loss, a common side effect of the chemotherapy drug cisplatin. Medulloblastoma is a brain cancer that can be low-risk or average-risk, depending on the chance of it coming back after treatment. The trial also looks at whether a less intense treatment can work just as well for low-risk patients, potentially causing fewer side effects. The main goals are to see if STS can protect hearing without affecting the success of the cancer treatment and to compare the outcomes of patients treated with STS to those who were not.

Description

The main aim of this study is to see if sodium thiosulfate (STS) can reduce hearing loss in children with average-risk medulloblastoma when given during chemotherapy. The study will also monitor how well patients do without the cancer coming back and compare these results to past patients who did not receive STS.

Secondary goals include checking overall survival rates, the need for changes in chemotherapy doses due to hearing issues, and any kidney problems caused by cisplatin. The study will also look at the impact on intelligence, quality of life, and social factors for patients treated with STS.

The study involves two parts: Chemoradiotherapy and Maintenance. During Chemoradiotherapy, patients receive radiation therapy and a chemotherapy drug called vincristine. In the Maintenance phase, patients take several medications, including lomustine, cisplatin, STS, and cyclophosphamide, over multiple cycles. Regular MRI scans and fluid samples will be collected to monitor progress.

After treatment, patients will have follow-up visits every few months for up to 10 years to track their health and any long-term effects.

Eligibility Criteria

Locations