Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07392580
Phase
PHASE2
Status
Recruiting
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Conditions

  • Laryngeal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    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.
  • Epinephrine injection — DRUG
    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.
  • Laryngeal Biopsy — PROCEDURE
    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.
  • Endoscopic Surgery — PROCEDURE
    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.

Study Details

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

Key Dates

Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Sep 1, 2031
Completion
Sep 1, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cisplatin + Epinephrine Group
    Participants in this group will receive one (1) dose of intralesional chemotherapy (IC) treatment per week over a period of approximately 3 weeks. IC treatment will consist of combination cisplatin and epinephrine. Participants will then go to have endoscopic surgery for their disease. Total participation duration is approximately 16 months.

Primary Outcome Measure

Overall Pathologic Response Rate (OPRR) [ Time Frame: About six (6) weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
David E Rosow, MD
[email protected]
+1 (305) 2432587
David E Rosow, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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