Exploratory trial of the systemic application of CIGB-128 (HeberPAG®) in Mycosis Fungoides, stages Ib to III

Center for Genetic Engineering and Biotechnology (CIGB)0 个研究点目标入组 12 人开始时间: 2012年6月8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: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1)Clinical and histological diagnosis of Mycosis Fungoides at stages IB, IIA, IIB, III, 2) Age between 18 and 75 years-old, both sex and any race. 3) Patients with measurable lesions, 4) Patients with more than 6 months of expectative of life, Karnofsky’s index superior or equal to 60%, 5) In case of patients that have received previous specific treatment a one-month washout period have to occur; 3 months for the case of patients treated with steroid (immunosuppressor) drugs, 6) Patients in fertile age that use contraceptive methods until three months after the treatment have been concluded, 7) Written, informed consent to participate.

•1) Pregnancy, puerperium, or nursing, 2) Hypersensibility to CIGB-128 (HeberPAG®) u other preparations used in the trial, 3) Uncompensated severe hypertension proven by clinical examination, 4) Chronic arterial insufficiency referred by the patient and proven through clinical examination, 5) Respiratory insufficiency or ischemic cardiopathy, 6) Diabetes Mellitus, Sickle cell disease or drepanocytic anemia, 7) Severe hematological affectations, proven by laboratory data (hemoglobin <100 g/L in women and <10 g/L in men), 8) Diseases with metabolic compromise (hepatopathies, nephropaties, pancreatopathies, collagenopathies) referred by the patient and proven through by laboratory and clinical examinations (AST, ALT, alkaline phosphatase, bilirrubin, creatinina, serum amylase), 9) Very compromised general state (cachexia, patients under a severe state, debilitating diseases), 10) Patients receiving other oncologic specific treatment or steroids at entry, 11) Patients under theophylline and/or anticoagulant treatments, 12) Other neoplasia, immunological diseases or concomitant infections referred by the patient and proven by the clinical examination, except for no-melanoma skin cancer, 13) Severe psychiatric dysfunction or other limitation that impede the patient to give their consent or difficult their evaluation.

发起方

Center for Genetic Engineering and Biotechnology (CIGB)