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Recruiting NCT07407582

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

Phase I / Phase II Interventional Solid Tumor Malignancies Testicular Cancer Head and Neck Cancer Thoracic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pedmark® STS.
Who it may be relevant to
Registry conditions: Solid Tumor Malignancies, Testicular Cancer, Head and Neck Cancer, Thoracic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase I/II Open Label Trial of Intravenous Sodium Thiosulfate (Pedmark®) as Otoprotectant in Adults Receiving Cisplatin Chemotherapy (STOP-CIS)

Overview

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.]
Secondary outcome measures (7)
  • 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Arizona Cancer Center — Tucson

Identifiers

NCT: NCT07407582 · STUDY00006997

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗