Inmuno gamma scanning with 99mtc-marked 14f7 MAbB in patients with colon/rectum tumor, Phase II

Center of Molecular Immunology (CIM)0 个研究点目标入组 20 人开始时间: 2010年12月17日最近更新: 2024年8月19日

适应症

试验速览

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研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Diagnostic

•1.Patients expressing their consent in writing to participate in the clinical trial. 2.Patients between 18 and 80 years of age. 3.Patients without another neoplasia history, except basal skin carcinoma or in situ cervical carcinoma. 4.Patients with general health condition lower than or equal to 2, according to WHO criteria. 5.Preserved kidney function with a creatinine parameter lower than 132 mmol/l. 6.Patients with hemoglobin values over 10 g/l, leukocytes over 4000 /mm3, platelets 100 x 109 and transaminase and alkaline phosphatase within 2.5 times the normal reference values. 7.The study will include patients of both sexes.

•1.Pregnancy or breastfeeding. 2.Reproductive-age patients not using contraceptive methods. 3.Fever due to acute or serious infectious diseases or convalescence (not exceeding 37oC). 4.Patients with history of decompensated chronic diseases such as: asthma, ischemic heart disease, diabetes mellitus, hepatitis and high blood pressure. 5.Patients with acute allergic conditions or history of severe allergic reactions. 6.Patients previously treated with murine or humanized MAb.

发起方

Center of Molecular Immunology (CIM)