Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)

Recruiting Phase 1 Phase 2 Interventional Study
Solid Tumor Malignancies Testicular Cancer Head and Neck Cancer Thoracic Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
University of Arizona · Other
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About This Trial
The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients is…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants have provided informed consent prior to initiation of any study-specific activities. * At least 18 years of age, male or female, at the time of signing the informed consent. * ECOG Performance Status 0-1 * Histologically or cytologically confirmed treatment-naïve …
Contacts

Alejandro Recio Boiles, MD

520-694-2873

areciomd@arizona.edu

CONTACT

Michele Chu-Pilli

520-626-1183

chum@arizona.edu

CONTACT