Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)
Summary
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.
Arms & interventions
- DrugPedmark® STS
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.
Outcome measures
Primary
Efficacy of intravenous STS to reduce hearing impairment associated with cisplatin
Proportion of participants with Brock grade ≥1 hearing loss determined from audiometry exams. The Brock ototoxicity classification and grading scale are as follows: Grade 0 = hearing threshold less than 40 dB HL at all test frequencies; Grade 1 = hearing threshold greater than or equal to 40 dB HL at 8 kHz only; Grade 2 = hearing threshold greater than or equal to 40 db HL at 4kHz and above; Grade 3 = hearing threshold greater than or equal to 40 dB HL at 2 kHz and above; Grade 4 = hearing threshold greater than or equal to 40 dB HL at 1 kHz and above.
Time frame: Baseline, after cumulative cisplatin dose (≥ 200 mg/m2), and at 3 months following the conclusion of cisplatin chemotherapy treatment.
Secondary
Tolerability of the administration of STS based on the adverse events
Time frame: At the end of treatment, up to 12 months from baseline.
Tolerability of the administration of STS: emetic control.
Time frame: At the end of treatment, up to 12 months from baseline.
Cisplatin pharmacokinetics: area under the plasma concentration versus time curve (AUC)
Time frame: At the first study treatment visit
Cisplatin pharmacokinetics: peak plasma concentration (Cmax)
Time frame: At the first study treatment visit
Cisplatin pharmacokinetics: elimination rate constant
Time frame: At the first study treatment visit
Cisplatin pharmacokinetics: half-life
Time frame: At the first study treatment visit
Cisplatin pharmacokinetics: total body clearance
Time frame: At the first study treatment visit
Eligibility criteria
Study locations (1)
University of Arizona Cancer Center
Tucson, Arizona, 85724