NCT07392580

Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laryngeal Squamous Cell Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2031-04-01
• Completion: 2031-04-01
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study