Overview

Sodium Thiosulfate for the Prevention of Ototoxicity in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck Undergoing Chemoradiation With Cisplatin

Status:
Active, not recruiting
Trial end date:
2024-03-06
Target enrollment:
0
Participant gender:
All
Summary
This phase II trial investigates how well sodium thiosulfate works in preventing ototoxicity (hearing loss/damage) in patients with squamous cell cancer of the head and neck that has spread to nearby tissue or lymph nodes (locally advanced) who are undergoing a chemoradiation. Sodium thiosulfate is a type of medication used to treat cyanide poisoning and to help lessen the side effects from cisplatin. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. The purpose of this trial is to find out whether it is feasible to give sodium thiosulfate 4 hours after each cisplatin infusion along with standard of care radiation therapy in patients with head and neck cancer. Giving sodium thiosulfate after cisplatin may help decrease the risk of hearing loss.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hyunseok Kang, MD
Collaborator:
NRG Oncology
Treatments:
Antidotes
Cisplatin
Sodium thiosulfate
Criteria
Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed locoregionally
advanced squamous cell carcinomas of mucosal surfaces of head and neck who are being
treated with concurrent chemoradiation with cisplatin

2. Participants must be eligible for cisplatin-based concurrent chemotherapy in
conjunction with at least 6 weeks of daily fractionated radiation therapy

3. Age >=18 years

4. Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)

5. Demonstrates adequate organ function as defined below:

1. Absolute neutrophil count >= 1,000/microliter (mcL)

2. Platelets >= 100,000/mcL

3. Total bilirubin within normal institutional limits, unless elevated due to
Gilbert's syndrome and direct bilirubin is within normal limits

4. Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase (SGOT))
=< 3 X institutional upper limit of normal

5. Alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase (SGPT)) =< 3 X
institutional upper limit of normal

6. Creatinine =< 1.5 x within institutional upper limit of normal OR creatinine
clearance glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2, calculated
using the Cockcroft-Gault equation, unless data exists supporting safe use at
lower kidney function values, no lower than 30 mL/min/1.73 m^2

6. Ability to understand a written informed consent document, and the willingness to sign
it

7. Individuals with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial

8. The effects of sodium thiosulfate (STS) on the developing human fetus are unknown. For
this reason and because cisplatin used in this trial are known to be teratogenic,
women of childbearing potential and men must agree to use adequate contraception such
as hormonal and/or barrier method of birth control for the duration of study
participation and for 3 months after last administration of study treatment. Should a
woman become pregnant or suspect she is pregnant while she or her partner is
participating in this study, she should inform her treating physician immediately. Men
treated or enrolled on this protocol must also agree to use adequate contraception
prior to the study, for the duration of study participation, and 3 months after last
administration of study treatment

Exclusion Criteria:

1. Participants that are not eligible for cisplatin-based chemoradiation for reasons such
as chronic kidney disease, severe hearing loss, and severe peripheral neuropathy

2. Uncontrolled inter-current illness or psychiatric illness/social situation that would
limit compliance with study requirements

3. Has known hypersensitivity to cisplatin, sodium thiosulfate or any of its excipients

4. Has profound hearing impairment at baseline and cannot hear a sound below 90 decibels
(dB)

5. Participants with uncompensated congestive heart failure New York Heart Association
(NYHA) class 3 or above

6. Participants who cannot get secure venous access using either a Mediport or a
peripherally inserted central catheter (PICC) line for safe administration of
intravenous sodium thiosulfate

7. Pregnant women are excluded from this study because cisplatin is a cytotoxic agent
with the potential for teratogenic or abortifacient effects. Because there is an
unknown but potential risk for adverse events in nursing infants secondary to
treatment of the mother with cisplatin or sodium thiosulfate, breastfeeding should be
discontinued if the mother is treated with either agent