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Facial Cancer clinical trials

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NCT ID: NCT03809208 Recruiting - Oral Cancer Clinical Trials

Birinapant and Intensity Modulated Re-Irradiation Therapy for Local-Regionally Recurrent Head and Neck Squamous Cell Carcinoma

Start date: April 15, 2019
Phase: Phase 1
Study type: Interventional

Background: Head and neck cancer is a group of cancers that start in the mouth, nose, throat, larynx and sinuses. The usual treatment is surgery, radiation, chemotherapy, or a combination of those. Approximately 50% of HPV-negative head and neck cancer patients that have been treated with any of these modalities will have a recurrence. For these patients, current treatment options include surgery and re-irradiation with chemotherapy, which can reduce symptoms and may stop the tumor from growing but in the majority of cases, only for a few months. In this trial, researchers want to see if they can cure or significantly lower the chance of head and neck cancer growing back or spreading by adding the new agent birinapant to re-irradiation. Objective: To test the safety of birinapant and re-irradiation at different doses in patients with head and neck cancer. Eligibility: Adults age 18 and older with head and neck cancer who are candidates for re-irradiation. Design: Participants will be screened with a review of their medical record. Participants will have exams and procedures that are part of their usual care. Participants will also have a test of heart activity before treatment. Participants will have urine pregnancy tests, if female. Participants will have blood and tumor samples taken 2 times and stored for research. The study lasts 6 weeks. Participants will get radiation for 5 days a week (Monday Friday) for all 6 weeks. Participant will get the study drug on 4 Tuesdays. They will get it in an arm vein over 30 minutes each time. About 4 weeks after the study ends, participants will have a follow-up visit. They will have a physical exam, health questions, and blood tests. Participants may have scans 4 times over the next 2 years. Participants will get an email or phone call every 6 months. Sponsoring Institute: National Cancer Institute