Phase 1 Study of Decitabine with Surgery, Radiation, and Chemotherapy for Treating Surgically Removable HPV-Negative Head and Neck Cancer

What this Trial Is About

Researchers are studying the safety, side effects, and best dose of decitabine combined with standard treatments such as surgery, radiation, and chemotherapy in patients with HPV-negative head and neck squamous cell cancers that can be surgically removed. Decitabine may help make tumor cells more sensitive to chemotherapy and radiation, potentially improving treatment outcomes. This is a phase I trial focusing on these effects and determining the optimal decitabine dose. Participants first receive decitabine intravenously once daily for 3 days before surgery, which is done within 28 days after decitabine. Following surgery, patients may receive decitabine again in cycles during radiation therapy, given once daily for 3 days every 3 weeks, alongside external beam radiation therapy for up to 5-35 treatments per standard care. Concurrent chemotherapy may also be given as part of standard treatment. Blood samples are collected throughout the study. During the study, participants undergo various assessments including monitoring for side effects, measuring event-free and overall survival, and quality of life evaluations. Follow-up visits occur 30 days after treatment ends, then every 4 to 6 months for 2 years, and annually up to 5 years. The primary outcomes focus on determining the maximum tolerated dose of decitabine in both the preoperative and adjuvant phases of treatment.

Decitabine in Combination With Standard of Care Therapy for the Treatment of Surgically Resectable HPV-Negative Head and Neck Cancer