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NOT YET RECRUITING
NCT07392580
PHASE2

Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

Sponsor: University of Miami

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the effects, good and bad, of injecting chemotherapy into recurrent laryngeal squamous cell carcinoma (SCC) tumors.

Official title: A Single-Arm, Open-Label Study of Intralesional Treatment of Laryngeal Squamous Cell Carcinoma With Cisplatin

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-04-01

Completion Date

2031-04-01

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

DRUG

Cisplatin

Participants will be administered 1 mg/mL Cisplatin via intralesional injection in combination with Epinephrine injection therapy. Total treatment volume will determined by the volume of the tumor to be injected.

DRUG

Epinephrine injection

Participants will be administered a 1:50,000 dilution of epinephrine via intralesional injection in combination with cisplatin therapy. The total treatment volume will determined by the volume of the tumor to be injected.

PROCEDURE

Laryngeal Biopsy

At the time of the first intralesional chemotherapy (IC) dose, participants will have a biopsy of tumor tissue taken for standard of care (SOC) clinical activities. A portion of this sample will, if available, be banked for transcriptomic analysis.

PROCEDURE

Endoscopic Surgery

Participants with early disease will go on to have endoscopic surgical resection of their cancer while participants with advanced disease will receive a total laryngectomy, after completion of intralesional chemotherapy (IC) therapy. Resected tissue collected at the time of the surgical procedure (either cordectomy or total laryngectomy) will also be banked for correlative studies.

Locations (1)

University of Miami

Miami, Florida, United States