Helixor® Infusion Study: a prospective dose finding study. Phase I - HIS-I-730-127-2012

Helixor Heilmittel GmbH & Co. KG0 个研究点目标入组 21 人开始时间: 2013年5月28日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1) Age >= 18 years and able to understand the scope of the study and to follow the instructions of the study
•investigator.
•2) Patient information according to applicable national legislation and international guidelines followed by
•signing and dating the informed consent form.
•3) Patients with a histological or cytological confirmed diagnosis of a far advanced malignant disease
•during a therapy-free interval.
•4) Patients with a performance according to ECOG: 0-2.
•5) Leukozytes >= 3.000/mm3
•6) Neutrophiles >= 1.500/ul
•7) Thrombocytes >= 100.000/mm3
•8) Female, pre-menopausal patients must provide negative pregnancy test within two weeks before study
•entry and are willing to apply a highly effective birth-control method.

•1. Pregnant or breast-feeding women.
•2. Co-morbidity with one of the following:
•a) HIV-infection/AIDS,
•b) severe allergic illness (including asthma);
•c) known hypersensitivity to mistletoe products,
•d) active tuberculosis,
•e) acute inflammatory diseases with body temperature > 38° C,
•f) severe systemic diseases as cardiac insufficiency,
•g) cardiac arrhythmias if clinically relevant,
•h) hyperthyroidism with tachycardia,
•i) autoimmune disease if florid or currently treated with immunosuppressive agents
•j) chronic granulomatous disease, e.g. Crohn’s disease or Sarcoidosis
•k) parasitosis,
•l) other concomitant diseases likely to make participation of the patient difficult at the discretion of the investigator.
•3. Treatment with one of the following:
•a) preceding therapy with mistletoe products,
•b) oncological therapies as follows: surgery, radiotherapy, chemotherapy
•c) participation in a clinical trial during the last 4 weeks.
•4. Laboratory parameters outside the following limits:
•a) Creatinine > 1.5 mg/dl
•b) Bilirubine > 3 x upper limit of institutional standard
•c) Transaminases > 3 x upper limit of institutional standard
•5. Known abuse of medicaments, alcohol or illegal drugs.
•6. Subjects which are in a state of dependence in relation to the sponsor’s or investigator’s institutions or which are their employees.

发起方

Helixor Heilmittel GmbH & Co. KG