Study of Injecting Cisplatin and Epinephrine Directly Into Recurrent Laryngeal Squamous Cell Carcinoma Tumors Before Surgery

What this Trial Is About

Researchers are evaluating the effects of injecting chemotherapy directly into tumors of recurrent laryngeal squamous cell carcinoma SCC. This study aims to understand both the benefits and risks of this treatment approach. The trial is a Phase 2, single-arm, open-label study sponsored by the University of Miami, focusing on patients previously treated for laryngeal SCC who now have recurrent disease requiring surgery. Participants will receive one dose per week of intralesional chemotherapy, which combines cisplatin and epinephrine, for about three weeks. After completing this treatment, they will undergo endoscopic surgery to remove the cancer. The type of surgery depends on disease severity, with early cases undergoing endoscopic resection and advanced cases receiving total laryngectomy. Tissue samples collected during treatment and surgery will be used for further analysis. Throughout the approximately 16-month participation, researchers will monitor participants using biopsies, imaging, and endoscopic evaluations. They will track overall pathologic response about six weeks after treatment, as well as radiographic and endoscopic responses around five weeks. Safety will be assessed by recording any treatment-related adverse events up to about 18 weeks. The study includes careful monitoring of blood counts and organ function to ensure participant safety.

Intralesional Chemotherapy (IC): Cisplatin + Epinephrine