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.

Lead Sponsor:

Otonomy, Inc.

Intervention(s):

  • Drug: OTO-104

Phase:

Phase 2

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