Intralesional Chemotherapy (IC): Cisplatin + Epinephrine

Korábbi kezelés

• 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.
• Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gastrointestinal (GI), endocrine, pulmonary, neurological, cerebral, or psychiatric disease.

Más betegség

• 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.
• 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).
• 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.

Egyéb

• Inability to tolerate awake, unsedated laryngeal procedures. Participants may opt to receive pre-procedure diazepam.
• Participant unable to receive contrast.
• Currently pregnant or breastfeeding.
• Patients with impaired decision-making capacity.

• 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.