The goal of this Phase III study is to evaluate in a multi-centered, randomized trial whether sodium thiosulfate (STS) is an effective and safe means of preventing hearing loss in children receiving cisplatin chemotherapy for newly diagnosed germ cell, liver (hepatoblastoma), brain (medulloblastoma), nerve tissue (neuroblastoma) or bone (osteosarcoma) cancers. Eligible children will be 1 to 18 years of age who are scheduled to receive cisplatin according to their disease-specific regimen and, upon enrollment onto this study, will be randomized to receive STS or placebo.
Efficacy of STS will be determined through comparison of hearing sensitivity at follow-up relative to baseline measurements using standard audiometric techniques. The trial is expected to enroll up to 120 patients over approximately three years in up to 230 Children’s Oncology Group (COG) centers in the US, Canada, Australia and Europe.
Adherex is providing drug and drug distribution for the study and will have exclusive use of the results for regulatory submissions. The company is also conducting a Phase III trial of STS in children with liver (hepatoblastoma) cancer in collaboration with the International Childhood Liver Tumour Strategy Group (known as SIOPEL), a multi-disciplinary group of specialists under the umbrella of the International Society of Pediatric Oncology, with centers in up to 33 countries expected to participate.
William Peters, chairman and CEO of Adherex, said: “Through this Phase III trial and our ongoing Phase III trial with the SIOPEL, we aim to globally recruit as many eligible children with cancer as quickly as possible to help prevent the hearing loss that these children and their parents have had to accept as part of their cancer treatment.”