Education and Training
Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
This is a multicenter, Phase 2 study to assess the feasibility, safety and efficacy of OTO-104 given by intratympanic administration in subjects at risk for ototoxicity from cisplatin chemotherapy regimens in the treatment of cancer.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: OTO-104
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
study.
- 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
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061
Not Recruiting