Safety of the CIGB-300 application associated to diphenhydramine pre-medication in the epidermoid carcinoma of the uterine neck stage Ib2-II. Phase I study.

Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点开始时间: 2013年5月16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: Uncontrolled. Assignment: Other. Purpose: Treatment

•1. Clinical, imagenological and histological diagnosis of stage IB-II epidermoid cervical cancer. 2. Age between 18-75 years, both included. 3. Written informed consent by the patient. 4. Clinical laboratory parameters within normal limits. 5. General health index from 0 to 2, according to WHO classification. 6. Life expectation of more than 1 year.

•1. To have received surgical, ablative or immunomodulatory treatment during the 30 days before inclusion. 2. Body Mass Index inferior to 19 or superior to 30. 3. Pregnancy or nursing. 4. Decompensate chronic disease (arterial hypertension, diabetes mellitus, chronic renal disease, cardiac insufficiency,hyperthyroidism, malignant neoplasia, epilepsy, severe mental depression). 5. Patients with previous diagnosis of coagulation dysfunctions and other decompensate chronic hematopahies (hemophilia, leukemia, among other). 6. Clinical laboratory values outside their normal ranges before the treatment. 7. Referred Immunosuppressor disease and current ingestion of immunosuppressor / immunomodulating drugs (including steroids) 30 days previous the study. 8. Autoimmune disorders (Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Type 1 Diabetes Mellitus, etc.) and severe allergic antecedents such as Urticaria, Dermatitis, or Bronchitis and persistent Bronchial Asthma. 9. Febrile illness (temperature >37.8°C) at the moment or 24 hours before administration of the product or acute infectious disease suspected by clinical examination. 10. Diseases that compromise the state of the patient's conscience or their possibility to give their informed consent or to collaborate in the trial. 11. Tumoral extensive necrosis that prevent the application of the product as indicate the protocol. 12. To be included in another clinical trial.

发起方

Center for Genetic Engineering and Biotechnology (CIGB)