A Phase III, Open-label, Randomized, Multi-center Study of the Effects of Leukocyte Interleukin, Injection [Multikine] Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity / Soft Palate Versus Standard of Care Only

Dr. E Talor0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•Ages Eligible for Study: 18 Years and older
•Genders Eligible for Study: Both
•Accepts Healthy Volunteers: No
•1. Untreated SCCHN of oral cavity/soft palate, categories T1N1-2M0,T2N1-2M0,T3N0-2M0,T4N0-2M0 (T4 allowed only if invasion of mandible is negligible) scheduled for SOC
•2. Primary tumor and any positive node(s)measurable in 2 dimensions
•3. Normal immune function
•4. No immunosuppressives with 1 year
•5. Karnofsky Performance Status (KPS) >70
•6. Age>18
•7. Male or Female (non-pregnant)
•8. Life expectancy >6 months
•9. Able to take oral medication
•10. Able to provide informed consent

•1. Subjects to be treated with other than SOC
•2. Tumor invasion of bone (also see inclusion criteria)
•3. Tumor classifications T1N0, T2N0, T4N3, any TN classification with M1
•4. Tumors in locations other than those specified in inclusion criteria
•5. Active peptic ulcer
•6. Prior resection of jugular nodes ipsilateral to tumor
•7. Acute or chronic viral, bacterial immune or other disease associated with abnormal immune function
•8. Subjects on hemodialysis or peritoneal dialysis
•9. History of asthma
•10. Any condition that in the opinion of the investigator would cause the subject to be unable to participate or tolerate the protocol regimen

发起方

Dr. E Talor