Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join 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 cannot join 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.
• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Albumin-binding Cisplatin Prodrug BTP-114. A proprietary, albumin-binding platinum (Pt)-based complex containing a prodrug form of the platinum compound cisplatin and a maleimide moiety, with an ability to strongly and selectively bind human serum albumin (HSA), and with potential antineoplastic activity. Upon intravenous administration, the maleimide group of BTP-114 rapidly conjugates with HSA in the bloodstream; this prolongs the blood circulation, enhances the half-life, and alters the biodistribution of BTP-114, as compared to cisplatin alone. Thus, BTP-114 demonstrates enhanced extravasation to the tumor, an increased accumulation in the tumor tissue and enhanced uptake by cancer cells. The prodrug form is reduced in the hypoxic tumor cell environment, which releases the highly cytotoxic active metabolite cisplatin. Once inside the tumor cell, cisplatin binds to nucleophilic groups, such as GC-rich sites, in DNA and induces intrastrand and interstrand DNA cross-links, resulting in apoptosis and cell growth inhibition. Compared to cisplatin alone, BTP-114 has improved selectivity towards tumor tissue, thereby enhancing efficacy while reducing systemic toxicities. NCI Drug Dictionary

Treatments listed in the registry

• 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.

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan
• endoscopy: Part of the study plan
• surgery: Part of the study plan

Main goals

• Overall Pathologic Response Rate (OPRR) (About six (6) weeks)

Other goals

• Number of Participants Experiencing Treatment-Related Serious Adverse Events (SAEs)
• Number of Participants Experiencing Treatment-Related Adverse Events (AEs)
• Overall Radiographic Response Rate (ORRR)
• Overall Endoscopic Response Rate (OERR)

Planned enrollment: 20 (estimated).

• University of Miami, Miami, Florida

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07392580
• NCI Drug Dictionary: C376

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 25, 2026. Public record; not medical advice.