Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

NCT07392580 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20250847
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)

  About 18 weeks

• Number of Participants Experiencing Treatment-Related Adverse Events (AEs)

  About 18 weeks

• Overall Radiographic Response Rate (ORRR)

  About five (5) weeks

• Overall Endoscopic Response Rate (OERR)

  About five (5) weeks

Study Arms (1)

Cisplatin + Epinephrine Group

EXPERIMENTAL

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; Drug: Epinephrine injection; Procedure: Laryngeal Biopsy; Procedure: Endoscopic Surgery

Interventions

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.

Cisplatin + Epinephrine Group

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.

Cisplatin + Epinephrine Group

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.

Also known as: Cordectomy, Laryngectomy

Cisplatin + Epinephrine Group

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.

Cisplatin + Epinephrine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 18 years and older.
• Previously treated for laryngeal SCC with radiation.
• 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.
• Participants must be willing to undergo 3 weekly cycles of IC under local anesthesia prior to surgery.
• Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):
• Absolute neutrophil count (ANC) ≥ 1.0 × 10\^9 cells /L.
• Hemoglobin ≥ 8.0 g/dL.
• Platelet count ≥ 50 × 10\^9 platelets/L.
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
• Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 ULN.
• 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.
• Willingness to avoid pregnancy based on the criteria below:
• 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).
• 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.

You may not qualify if:

• Inability to tolerate awake, unsedated laryngeal procedures. Participants may opt to receive pre-procedure diazepam.
• Participant unable to receive contrast.
• Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
• Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of trial intervention:
• \< 10 weeks from completion of any radio- or toxin-immunoconjugates.
• \< 4 weeks for immunotherapy.
• \< 3 weeks for radiotherapy.
• \< 2 weeks for any investigational agent or other anticancer medications.
• 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.
• Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
• 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.
• Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal (GI), endocrine, pulmonary, neurological, cerebral, or psychiatric disease.
• Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of dosing.
• Known human immunodeficiency virus (HIV) infection or positivity on immunoassay. Note: HIV screening test is optional.
• Current New York Heart Association Class II to IV congestive heart failure.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Epinephrine; Endoscopy; Laryngectomy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures

Study Officials

• David Rosow, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David E Rosow, MD

CONTACT

+1 (305) 2432587; DRosow@med.miami.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)