Feasibility and Safety of Intratympanic Administration of Sustained‐Exposure Dexamethasone Thermosensitive Gel (OTO‐104) for Prevention of Cisplatin‐Induced Hearing Loss in Children: A Multisite Phase 2 Randomized Clinical Trial
Although dexamethasone at this dose was not otoprotective, these results suggest that intratympanic injection may be safe, feasible, and a viable delivery platform for testing other otoprotectants.
Authors
- Debra M. Don (ORCID: https://orcid.org/0000-0003-1906-9262)
- Robert J. Hayashi (ORCID: https://orcid.org/0000-0002-1140-1139)
- Eli Grunstein (ORCID: https://orcid.org/0000-0003-1158-9052)
- Daniel Choo (ORCID: https://orcid.org/0000-0003-1974-2680)
- Etan Orgel (ORCID: https://orcid.org/0000-0002-1487-6818)
- Kenny H. Chan (ORCID: https://orcid.org/0000-0001-9989-1322)
- Reza Rahbar (ORCID: https://orcid.org/0000-0002-6531-5922)
- Kay W. Chang
- Matthew Sitton
- Jennifer H. Foster (ORCID: https://orcid.org/0000-0002-2126-9768)
- Judith E. C. Lieu (ORCID: https://orcid.org/0000-0001-7933-5601)
- Allison F. O’Neill (ORCID: https://orcid.org/0000-0002-8957-3870)
- Arun Rangaswami
- James I. Geller (ORCID: https://orcid.org/0000-0001-5181-116X)
- Brian Greffe
- David R. Freyer (ORCID: https://orcid.org/0000-0001-5280-990X)
- Timothy J. D. Ohlsen (ORCID: https://orcid.org/0000-0002-1098-2330)
- Alice Lee (ORCID: https://orcid.org/0000-0003-4538-7563)
- Jeffery J. Anderson
Institutions
- University of Southern California (US)
- Cincinnati Children's Hospital Medical Center (US)
- Boston Children's Hospital (US)
- Morgan Stanley Children's Hospital (US)
- Seattle Children's Hospital (US)
- Lucile Packard Children's Hospital (US)
- Children's Hospital of Los Angeles (US)
- University of California, San Francisco (US)
- University of Washington (US)
- Washington University in St. Louis (US)
- Children's Hospital Colorado (US)
- Texas Children's Hospital (US)
- Children's Hospital & Medical Center (US)
- Otonomy (United States) (US)
- Dana-Farber/Boston Children's Cancer and Blood Disorders Center (US)
- University of Colorado Denver (US)
- Stanford University (US)
Publication Details
- Journal
- Pediatric Blood & Cancer
- Published
- 2025-03-24
- DOI
- https://doi.org/10.1002/pbc.31680
- Primary Topic
- Ear and Head Tumors
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Otonomy