Study on Injecting Chemotherapy into Recurrent Laryngeal Cancer Tumors

Inclusion Criteria

• Men and women aged 18 and older.
• Previously treated with radiation for laryngeal cancer.
• Must have a confirmed return of cancer that requires surgery. If no previous tissue sample is available, a new biopsy may be needed to confirm the diagnosis and eligibility for the trial.
• Willing to undergo three weekly cycles of the injection treatment under local anesthesia before surgery.
• Have adequate blood, liver, and kidney function based on recent tests:
  • Neutrophil count of at least 1.0 × 10^9 cells/L.
  • Hemoglobin level of at least 8.0 g/dL.
  • Platelet count of at least 50 × 10^9 platelets/L.
  • Total bilirubin level no more than 1.5 times the normal limit.
  • Liver enzymes (ALT/AST) no more than 3 times the normal limit.
  • Kidney function with creatinine clearance of at least 45 mL/min.
• Women must agree to avoid pregnancy during the study and for 14 months after the last treatment, using highly effective birth control methods.

Exclusion Criteria

• Cannot tolerate procedures on the larynx while awake. Sedation with diazepam is an option.
• Unable to receive contrast agents.
• Currently receiving other cancer treatments like chemotherapy, radiation, or immunotherapy.
• Recent use of certain cancer treatments within specified timeframes before starting the trial:
  • Less than 10 weeks since completing radio- or toxin-immunoconjugates.
  • Less than 4 weeks since immunotherapy.
  • Less than 3 weeks since radiotherapy.
  • Less than 2 weeks since investigational or other cancer medications.
  • Steroids for allergies or other conditions are allowed, but not for cancer treatment. Steroid dose must be 10 mg/day or less within 7 days of starting the trial.
• Not fully recovered from major surgery complications.
• Other cancers within the last 3 years, except for certain non-threatening types.
• Uncontrolled medical conditions affecting major organs or systems.
• Active infections needing treatment or recent live vaccine exposure.
• HIV positive or known infection.
• Heart failure or recent heart issues, liver cirrhosis, or autoimmune disorders needing immunosuppression.
• Pregnant or breastfeeding.
• Any condition that might interfere with participating fully in the trial or pose a risk to the patient.
• Impaired decision-making ability.