C00-C97
Conditions
Interventions
Group 1: There are seven Dose Groups (DG): 50 mg, 100 mg, 200 mg , 400 mg,
700 mg, 1.200 mg and 2.000 mg Helixor® P. The study begins with 200 mg.
Two lower dose groups (100 mg or 50 mg) will only be
Sponsors
Helixor Heilmittel GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine maximum dose (MTD) of Helixor® P as an intravenous infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate safety and tolerability of Helixor® P as an intravenous infusion | — |
Countries
Germany
Contacts
Public ContactRoman Huber
Uni-Zentrum Naturheilkunde Universitätsklinikum Freiburg
Outcome results
None listed