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

CEL-SCI Corporation0 个研究点目标入组 1,273 人开始时间: 2014年8月29日最近更新: 2019年6月30日

试验速览

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•Previously untreated primary squamous cell carcinoma of the oral cavity inclusive of the tongue
•(not the base of tongue), floor of mouth, cheek and soft palate only, confirmed by biopsy, with or without regional lymph nodal metastases, deemed curable by and scheduled for definitive treatment by surgical resection and postoperative radiation therapy or surgical resection and
•postoperative concurrent chemo- radiotherapy (standard of care). Tumors in other locations (and those in other locations of the head and neck) are excluded.
•Other key inclusions: primary tumor,
•and if present, clinically positive lymph node(s) measurable in two
•dimensions, normal immune function, no immunosuppressive drugs
•within the past year, Karnofsky Performance Status (KPS) = 70, age =
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1146
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 127

•1. Subjects other than those to be treated by surgery, followed by radiation therapy +/- chemotherapy and/or those for whom surgery would be scheduled prior to Day 8 from enrollment /randomization.
•2. Tumor invasion of bone as detected by a suitable imaging technique MRI
•and/or CT or by physical examination, except for mandibular invasion.
•3. Any T1N0 or T2N0 stage tumors and all tumors classified as T4, N3
•and/or any TN classification with M1 or greater (Note: only M0 is allowed
•in this study).
•4. Active peptic ulcer disease despite ongoing adequate medical therapy.
•5. Prior surgical resection of the jugular lymph nodes on the ipsilateral neck that the injection is to be administered.
•6. Any acute or chronic viral, bacterial, immune or other disease in a stage
•usually associated with abnormal cellular immunity (e.g., HIV infection,
•hepatitis, nephritis, lung disease, rheumatoid arthritis or other autoimmune disease).
•7. Subjects on hemodialysis or peritoneal dialysis.
•8. Prior history of asthma.
•9. Prior completion of one or more courses of therapeutic irradiation,
•excluding such treatment of the extremities.
•10. History of allergic reaction to fluoroquinolone antibiotics (e.g.,
•ciprofloxacin, ofloxacin).
•11. History of any other malignancy, excluding basal cell carcinoma of the
•skin and in-situ carcinoma of the cervix.
•12. History of congestive heart failure (CHF) and other heart conditions.

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