Evaluation of a multivalent fragment of radiomarked anti-CEA antibody in colorectal cancer patients. Clinical trial, phase I.

Center for Genetic Engineering and Biothecnology (CIGB)0 个研究点目标入组 20 人开始时间: 2010年12月20日最近更新: 2024年8月19日

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研究类型: Interventional
分配方式: Non-randomized controlled trial. Masking: Open. Control group: Uncontrolled. Assignment: Other. Purpose: Diagnostic

•Histological diagnosis of colon or rectum adenocarcinoma, any clinical stage, with no previous Onco-specific treatment. Demonstration of CEA antigen expression in tumoral tissue using immunohistochemical technique. General clinical condition lower than or equal to 2 under WHO criteria. Patients aged 18 to 80, both sexes, any race. Contraceptive use in reproductive age women. Patients giving informed consent in writing to participate in the research and undergo relevant tests.

•History of neoplasia other than basocellular skin carcinoma or in situ cervix carcinoma. Previous onco-specific treatment. Previous administration of any murine, chimeric or humanized antibody. History of allergy or hypersensitivity to iodine-containing preparations. Uncontrolled chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, viral hepatitis, and high blood pressure. Hemoglobin values <10 g/L, total leucocytes <4,000/mm3, and platelets <100 x 109 cel/L. Kidney failure caused by creatinine clearing values < 60 mL/min, and liver failure caused by TGP and/or TGO values 2.5 times higher than the normal upper limit in technique under use. Fever due to acute or serious infectious diseases or convalescence (not exceeding 37.50C). Pregnancy, breastfeeding or puerperium. Reproductive age women with positive pregnancy tests. Serious psychiatric or neurological disorder or mental handicap.

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Center for Genetic Engineering and Biothecnology (CIGB)