Sodium Thiosulfate Otoprotection During Salvage Cisplatin Therapy
Stopped: This study will be closing at CCHMC and may be transferred to a principal investigator at another insitutiton.
United States33 participantsStarted 2023-03-01
Plain-language summary
This study will attempt to demonstrate the efficacy of Sodium Thiosulfate (STS) in preventing hearing loss in patients re-treated with cisplatin-based therapy according to regimens Cisplatin and STS (regimen CS) and Cisplatin, STS and Vorinostat/SAHA (regimen CSS).
Who can participate
Age range1 Month – 39 Years
SexALL
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Inclusion criteria
✓. Stratum 1: Arm CS (Cisplatin/STS): Previously chemosensitive to cisplatin defined as an AFP drop of 1 log (90%) and/or an objective tumor response of 30% or greater on imaging while receiving cisplatin.
✓. Stratum 2A: Cisplatin/STS/SAHA (CSS): Previously chemosensitive but with noted subsequent progression on cisplatin or initially chemoresistant to cisplatin (all other hepatoblastoma patients). Resistance to cisplatin is defined as rising alpha-fetoprotein (AFP) x 2 consecutive measurements or imaging progression including growth of known lesions or new lesions while patient is receiving a cycle of chemotherapy containing cisplatin or relapse noted within 3 months of last cisplatin administration.
✓. Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study. Previous SAHA administration is permitted. Tacrolimus and Sirolimus with levels \<= 10 ng/ml are not considered myelosuppressive.
✓. Immunotherapy: Must not have received within 2 weeks of entry onto this study.
✓. Radiation therapy (RT): greater than or equal to 2 weeks for local palliative RT (small port); greater than or equal to 6 months must have elapsed if prior craniospinal RT or if greater than or equal to 50% radiation of pelvis
✓. Adequate Bone Marrow Function Defined as:
✓. Peripheral absolute neutrophil count (ANC) greater than or equal to 750/uL
Exclusion criteria
✕. Female patients who are pregnant or breast-feeding will not be entered in the study. A negative pregnancy test within 72 hours of starting therapy is required for female patients of childbearing potential
What they're measuring
1
Prevention of hearing loss
Timeframe: Through study completion up to 5 years
Trial details
NCT IDNCT05756660
SponsorChildren's Hospital Medical Center, Cincinnati
✕. Lactating females who plan to breastfeed their infants.
✕. Sexually active patients of reproductive potential must agree to use an effective contraceptive method for the duration of their study participation