Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

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

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

Study Overview

• Status: Recruiting
• Conditions: Laryngeal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Cisplatin; Drug: Epinephrine injection; Procedure: Laryngeal Biopsy; Procedure: Endoscopic Surgery

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: David E Rosow, MD; Phone Number: +1 (305) 2432587; Email: DRosow@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: David E Rosow, MD; Phone Number: +1 (305) 2432587; Email: DRosow@med.miami.edu
      • Principal Investigator: David E Rosow, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men and women 18 years and older.
2. Previously treated for laryngeal SCC with radiation.
3. Must have biopsy-proven recurrent cancer requiring surgical management. Note: if participants do not have an archived tissue sample available for review, they may undergo a biopsy procedure for collection of a fresh tissue sample for diagnostic confirmation and determination of further treatment. In this case, a fresh tumor sample would be used for diagnostic confirmation and trial eligibility. Please note, this biopsy would be considered a standard of care (SOC) procedure since it is being performed for disease management purposes regardless of participant enrollment in the trial.
4. Participants must be willing to undergo 3 weekly cycles of IC under local anesthesia prior to surgery.

5. Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):

   1. Absolute neutrophil count (ANC) ≥ 1.0 × 10^9 cells /L.
   2. Hemoglobin ≥ 8.0 g/dL.
   3. Platelet count ≥ 50 × 10^9 platelets/L.
   4. Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
   5. Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 ULN.
   6. Calculated creatinine clearance ≥ 45 mL/min by the Cockcroft-Gault Equation or the estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula.

6. Willingness to avoid pregnancy based on the criteria below:

   1. Woman of non-childbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 45 years of age).
   2. Woman of childbearing potential who has a negative urine or serum pregnancy test at screening and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening and for at least 14 months after the last dose of trial intervention. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participant and their understanding confirmed.

Exclusion Criteria:

1. Inability to tolerate awake, unsedated laryngeal procedures. Participants may opt to receive pre-procedure diazepam.
2. Participant unable to receive contrast.
3. Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).

4. Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of trial intervention:

   1. < 10 weeks from completion of any radio- or toxin-immunoconjugates.
   2. < 4 weeks for immunotherapy.
   3. < 3 weeks for radiotherapy.
   4. < 2 weeks for any investigational agent or other anticancer medications.
   5. Steroids that are used for treatment of allergy or other underlying condition are permittable but not steroids started to treat cancer. Individuals receiving corticosteroids must be at a dose level ≤ 10 mg/day within 7 days of the trial intervention administration.
5. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
6. Current or previous other malignancy within 3 years of trial entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
7. Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal (GI), endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
8. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of dosing.
9. Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Note: HIV screening test is optional.
10. Current New York Heart Association Class II to IV congestive heart failure.
11. Uncontrolled or symptomatic arrhythmia or stroke in last 6 months, liver cirrhosis, or autoimmune disorder requiring immunosuppression or long-term corticosteroids (> 10 mg daily prednisone equivalent).
12. Currently pregnant or breastfeeding.
13. Any condition that would, in the Investigator's judgment, interfere with full participation in the trial, including administration of trial intervention and attending required trial visits; pose a significant risk to the patient; or interfere with interpretation of trial data.
14. Patients with impaired decision-making capacity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.; Other Names: Cordectomy; Laryngectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Pathologic Response Rate (OPRR)	Overall Pathologic Response Rate (OPRR) is defined as the number of participants with a complete response (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment. ORRR will be assessed by pathology as percentage viable tumor on histopathology at time of surgical resection.	About six (6) weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)	Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related serious adverse events (SAEs). SAEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion.	About 18 weeks
Number of Participants Experiencing Treatment-Related Adverse Events (AEs)	Incidence of treatment-related toxicity will be reported as the number of participants experiencing treatment-related adverse events (AEs). AEs will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, per physician discretion.	About 18 weeks
Overall Radiographic Response Rate (ORRR)	Overall Radiographic Response Rate (ORRR) is defined as the number of participants with a complete responses (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment by radiography (percent regression on computed tomography (CT) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, per physician discretion.	About five (5) weeks
Overall Endoscopic Response Rate (OERR)	Overall Endoscopic Response Rate (OERR) is defined as the number of participants with a complete response (CR) or partial response (PR) as the best response to intralesional chemotherapy (IC) treatment by endoscopy (percent regression determined by blinded raters of pre- and post-IC endoscopy).	About five (5) weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: David Rosow, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Organic Chemicals; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Catechols; Phenols; Benzene Derivatives; Diagnostic Techniques, Surgical; Alcohols; Platinum Compounds; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Otorhinolaryngologic Surgical Procedures; Cisplatin; Epinephrine; Endoscopy; Laryngectomy
• Other Study ID Numbers: 20250847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No