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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
University of Arizona
Study ID
NCT07407582
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pedmark® STS — DRUG
    Pedmark® STS (20 g/m2) will be given via intravenous infusion over 15-30 minutes, starting 6 hours after the completion of cisplatin infusion. Pedmark® STS will be given each day of cisplatin infusion.

Study Details

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 limited. As most cisplatin is administered in the adult population, this investigation would be of benefit.

Key Dates

Start date
May 18, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Treatment Arm
    Study participants will receive Pedmark® STS via intravenous infusion after the completion of their standard of care cisplatin infusion.

Primary Outcome Measure

Efficacy of intravenous STS to reduce hearing impairment associated with cisplatin [ Time Frame: Baseline, after cumulative cisplatin dose (≥ 200 mg/m2), and at 3 months following the conclusion of cisplatin chemotherapy treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724
Alejandro Recio-Boiles, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tucson, AZ

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Arizona Cancer Center· Tucson, AZ

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