Phase II study: Active specific immunotherapy with the 1e10 anti idiotype vaccine in the treatment of patients with advanced non small cell lung Cancer

Center of Molecular Immunology (CIM)0 个研究点目标入组 176 人开始时间: 2010年12月28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: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1. Patients that have signed the informed consent. 2. Patients with complete response or with measurable lesions* of the disease with partial response or stable when finishing the standard first line of Chemotherapy/Radiotherapy. 3. Patients whose time interval between finishing the oncospecific treatment and starting the vaccination is between 28 and 56 days. 4. Patient age between 18 and 75 years old, both inclusive. 5. General status according to ECOG < 2 (Karnofsky > 60 %). 6. Patients that have normal functioning of organs defined by the following parameters: Hemoglobin>¬ 90 g/L, Total leukocytes count> 3.0 x 109/L, Absolute neutrophils count>1.5 x 109/L, Platelet count>¬100 x 109/L, Total Bilirubin: Within normal limits. TGP and TGO: ¬2.5 times the normal highest institutional limit. Creatinine: Within normal limits for each institution. Blood glucose: Within normal limits for each institution. Total and fractioned proteins: Within normal limits for each institution. 7. Life expectancy of 4 months or more.

•1. Pregnant or breastfeeding patients. 2. Patients that have received any type of immunotherapy for NSCLC. 3. Patients with known hypersensitivity to any component of the formulation. 4. Patients of both sexes in fertile age that are not using an adequate contraceptive method (intrauterine device, hormone contraceptive, barrier methods or tubal ligation). In case of the male sex (vasectomy, use of condom) while treatment duration. 5. Patients that are receiving another research drug. 6. Patients with autoimmune diseases or decompensated chronic diseases. 7. Patients with acute allergic status or history of severe allergic reactions. 8. Patients with brain metastases or other primary neoplastic lesion. 9. Patients with prior history of demyelinizing or inflammatory diseases of the CNS or peripheral nervous system. 10. Patients with intercurrent non controlled diseases including active infections, symptomatic congestive cardiac insufficiency, unstable chest angina, cardiac arrhythmia and psychiatric diseases that imply the incompetence of the individual. 11. Patients with malignant diseases in the previous 5 years, except skin cancer (not melanoma). 12. Patients that are receiving systemic corticosteroids. 13. Patients with known HIV, B and C hepatitis.

发起方

Center of Molecular Immunology (CIM)