Laryngeal Squamous Cell CarcinomaPhase 2NCT07392580
Intralesional Chemotherapy (IC): Cisplatin + Epinephrine
A Phase 2 study testing Cisplatin, Epinephrine injection and Laryngeal Biopsy in people with Laryngeal Squamous Cell Carcinoma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Squamous Cell Carcinoma
- What is being tested?
- Cisplatin, Epinephrine injection and Laryngeal Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 1 Sep 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- < 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.
- 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).
- Currently pregnant or breastfeeding.
- 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.
- Patients with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
David E Rosow, MD, +1 (305) 2432587, DRosow@med.miami.edu
David E Rosow, MD
About this study
Official title: 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.
- Conditions
- Laryngeal Squamous Cell Carcinoma
- Being tested
- Cisplatin, Epinephrine injection, Laryngeal Biopsy, Endoscopic Surgery
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
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 injectionDrug
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 BiopsyProcedure or surgery
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 SurgeryProcedure or surgery
Also called Cordectomy, Laryngectomy
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cisplatin; Drug: Epinephrine injection; Procedure: Laryngeal Biopsy; Procedure: Endoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: About six (6) weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: About five (5) weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Rosow, University of Miami
- Investigators
- David Rosow, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392580
- Sponsor's protocol ID
- 20250847
- Status last verified
- Aug 2026
- First submitted
- 30 Jan 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Study of Intralesional Treatment of Laryngeal Squamous Cell Carcinoma With Cisplatin
- ClinicalTrials.gov ID
- NCT07392580
- Acronym / sponsor ID
- 20250847
- Conditions
- Laryngeal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin + Epinephrine Group | Experimental | Drug: Cisplatin, Drug: Epinephrine injection, Procedure: Laryngeal Biopsy, Procedure: Endoscopic SurgeryParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
Key exclusion criteria (19 listed)
- 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:
- Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CisplatinParticipants 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 | Cisplatin + Epinephrine Group |
| Epinephrine injectionParticipants 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. | Drug | Cisplatin + Epinephrine Group |
| Laryngeal BiopsyAt 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 or surgery | Cisplatin + Epinephrine Group |
| Endoscopic SurgeryAlso: Cordectomy, LaryngectomyParticipants 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. | Procedure or surgery | Cisplatin + Epinephrine Group |
Primary outcome
Overall Pathologic Response Rate (OPRR)
Time frame: About six (6) weeks
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.
4 secondary outcomes
Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)
Time frame: About 18 weeks
Number of Participants Experiencing Treatment-Related Adverse Events (AEs)
Time frame: About 18 weeks
Overall Radiographic Response Rate (ORRR)
Time frame: About five (5) weeks
Overall Endoscopic Response Rate (OERR)
Time frame: About five (5) weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Rosow, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin, Epinephrine injection and Laryngeal Biopsy in people with Laryngeal Squamous Cell Carcinoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David E Rosow, MD (+1 (305) 2432587, DRosow@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Pathologic Response Rate (OPRR) (time frame: About six (6) weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.