Phase I study with the HER1 / VSSP therapeutic vaccine in patients with hormone-castration-resistant prostate cancer, advanced squamous cell carcinoma of the head and neck and colon cancer

Center of Molecular Immunology (CIM)0 个研究点目标入组 120 人开始时间: 2017年11月3日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Parallel. Purpose: Treatment

•1. Compliance with one of the defined diagnostic criteria.
•2. Availability of the blocks to evaluate the expression, by immunohistochemical techniques, of R-EGF and biomarkers (such as K-ras, N-ras, B-raf, HPV and p16).
•3. Patient giving written informed consent to participation.
•4. Age over 18 years.
•5. General condition according to ECOG = 2.
•6. Life expectancy of at least 6 months.
•7. Functioning of organs and bone marrow defined by the following parameters: Hemoglobin (Hb) = 10 g / dl, Total white blood cell count = 3 x 109 / L, 100 Platelet count (CP) = 100 x 109 / L , total bilirubin = 2.5 times the upper normal institutional limit, creatinine within normal limits for each institution.

•1. Patients of childbearing potential who are not using a suitable method of contraception prior to their inclusion in the study (intrauterine devices, hormonal contraceptives, barrier methods or surgical sterilization).
•2. Pregnant or breastfeeding.
•3. Positive serology known to HIV, hepatitis B or C.
•4. Acute allergic states or history of severe allergic reactions.
•5. Acute or chronic decompensated lung diseases that may interfere with the follow-up of the underlying disease.
•6. Previous history of demyelinating or inflammatory diseases of the central nervous system (CNS) or peripheral (PNS).
•7. Uncontrolled intercurrent diseases including, but not limited to: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, Diabetes Mellitus, and psychiatric diseases involving the incompetence of the subject.
•8. Cerebral metastasis.
•9. Known hypersensitivity to any component of the formulation.
•10. Patients who are receiving another product under investigation.

发起方

Center of Molecular Immunology (CIM)