The International Childhood Liver Tumour Strategy Group (SIOPEL) has planned for patient enrollment in the UK, with SIOPEL centers in up to 33 further countries also expected to participate following the international launch of the trial at a SIOPEL meeting in Mumbai, India.
The trial is expected to enroll approximately 100 evaluable children with liver cancer (hepatoblastoma), an orphan disease, being treated with cisplatin. Patients will be randomized to receive either cisplatin alone, a platinum-based drug associated with frequent hearing loss used to treat hepatoblastoma, or cisplatin plus sodium thiosulfate (STS).
The study, which will be coordinated through the Children’s Cancer and Leukaemia Group in the UK, will compare the level of hearing loss (ototoxicity) associated with cisplatin alone versus the combination of cisplatin plus STS, as well as the safety, tolerability and anti-tumor activity in both arms of the study.
William Peters, chairman and CEO of Adherex, said: “The launch of this Phase III trial with SIOPEL is another important step forward in Adherex’s development of STS as a protectant against ototoxicity. We hope to change the fact that there are currently no approved drugs to protect against this type of hearing loss.”