Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss
Trial ID or NCT#
NCT02997189
Status
NOT RECRUITING
Purpose
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.
Official Title
A Multicenter, Randomized, 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
Eligibility Criteria
Ages Eligible for Study: 6 Months to 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Sheri Spunt
Kay W. Chang, MD
Pediatric otolaryngologist,
Medical Otologist
Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Pediatrics
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
