Trial Search Results
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
The objective is to assess the feasibility, safety and efficacy of up to 3 intratympanic administrations of OTO-104 in the study drug ear compared to no treatment in the control ear in subjects aged 6 months to 21 years, inclusive, receiving cisplatin chemotherapy regimens to treat cancer.
Stanford is currently not accepting patients for this trial.
- Drug: OTO-104
- Subject is aged 6 months to 21 years inclusive.
- Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial
germ cell tumors and has not been previously treated with cisplatin or carboplatin.
- Subject is scheduled to receive a chemotherapy regimen that includes a cumulative
cisplatin dose of ≥ 200 mg/m2.
- Subject has normal baseline auditory function, defined as ≤ 20 dB from 2000 to 8000
Hz, in both ears and does not have a history of sensorineural hearing loss.
- Subject has middle ear effusion upon clinical examination.
- Subject has a history of central nervous system radiotherapy that encompasses all or
part of the cochlea or will receive such radiation therapy during the course of the
- Subject is receiving sodium-thiosulfate or amifostine therapy with chemotherapy.
- Subject is currently participating on a separate otoprotection clinical study.
Ages Eligible for Study
6 Months - 21 Years
Genders Eligible for Study