NCT07407582 · University of Arizona
Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)
What this study is about
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 the usual treatment 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.
View original scientific description
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.
Interventions
DRUG
Pedmark® 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.
Primary outcome measures
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 cancer.
- Scheduled to receive an FDA-approved, on-label indication, standard of care systemic cisplatin-based regimen (at least 200 mg/m2 cumulative dose) for any untreated any solid malignancy deemed by the treating physician
Exclusion criteria
- Prior cisplatin exposure due to a cancer treatment history
- Concurrent ototoxic medication unable to be safely discontinued or switched to a non-toxic alternative
- Planned radiation to the head or neck prior to, during, or within 3 months of completion of cisplatin
- History of severe hypersensitivity to sulfite, sodium thiosulfate, or any components
- Baseline serum sodium \> 145 mmol/L or any grade ≥ 3 electrolyte abnormality
- Cisplatin infusion duration greater than 6 hours
- Females during pregnancy or breastfeeding, and childbearing potential, unwilling to use a method of contraception during treatment
- Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment
- Subject likely not to be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (i.e., Clinical Outcome Assessments) to the best of the subject's and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Where
- Tucson, Arizona
Collaborators
Fennec Pharma
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations