Intralesional Cisplatin and Epinephrine for the Treatment of Recurrent Resectable Laryngeal Squamous Cell Carcinoma

Inclusion Criteria

• 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
• Absolute neutrophil count (ANC) ≥ 1.0 × 10^9 cells /L (tested within 6 weeks prior to the start of therapy [values must not be achieved with growth factors])
• Hemoglobin ≥ 8.0 g/dL (tested within 6 weeks prior to the start of therapy [values must not be achieved with growth factors])
• Platelet count ≥ 50 × 10^9 platelets/L (tested within 6 weeks prior to the start of therapy [values must not be achieved with growth factors])
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (tested within 6 weeks prior to the start of therapy [values must not be achieved with growth factors])
• Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≤ 3.0 ULN (tested within 6 weeks prior to the start of therapy [values must not be achieved with growth factors])
• Calculated creatinine clearance ≥ 45 mL/min by the Cockcroft-Gault Equation or the estimated glomerular filtration rate ≥ 45 mL/min/1.73 m^2 using the Modification of Diet in Renal Disease formula (tested within 6 weeks prior to the start of therapy [values must not be achieved with growth factors])
• Willingness to avoid pregnancy based on the criteria below: * Woman of nonchildbearing 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

Exclusion Criteria

• 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