Advanced Cancer Clinical Trial
Official title:
A Prospective Dose Finding Study of Iscador Infusion: Phase Ib Study With Prolonged Observation (ISINFULA)
Prospective, dose-escalating mono-center open label dose-finding study without control group
(3+3 design), including a follow-up on-treatment observation. In this study will be recruited
15 patients with a histologically or cytologically confirmed diagnosis of an advanced
malignant disease during a therapy-free interval.Investigational drug:Iscador®P: fermented
aqueous extract of mistletoe grown on pine tree (Viscum album L. subspecies austriacum
(Wiesb.) Vollmann), licensed for subcutaneous (SC) application in Switzerland, Germany,
Austria, Sweden, and South Korea in dosages up to 20 mg.
The initial dose group of the study is set to 40 mg Iscador®P.
This is a prospective open label dose finding study (phase I) of Iscador®P in patients with
histological or cytological confirmed diagnosis of an advanced malignant disease during a
therapy-free interval. Primary objective : To determine the maximum tolerated dose (MTD) of
Iscador®P as intravenous infusion in the aforementioned patient population, based on the
incidence of dose-limiting toxicities (DLTs). Secondary objective :To investigate safety and
tolerability of long-term intravenous infusion of Iscador®P based on incidence and severity
of adverse drug reactions.
All patients are receiving best supportive care and may receive, if necessary, specified
concomitant therapies, which should not interfere with the safety parameters chosen for this
study.
Investigational therapy will be administered in six Dose Groups (DG): 10 mg, 20 mg, 40 mg, 90
mg, 140 mg and 200 mg Iscador®P. The initial dose group of the study is set to 40 mg
Iscador®P.
The two lower dose groups (20 or 10 mg) will only be used in case of intolerance at 40 mg
Iscador®P. Once per week patients receive intravenous infusions of Iscador®P dissolved in 250
ml of sodium chloride solution (0.9 %). After the 4-week period of the MTD estimation phase
each subject will immediately be included into a follow up observation in which he/she
receives the last well tolerated dosage they had or the next lower dosage than the currently
investigated DG in the running phase Ib study depending on the current estimate of the MTD at
that time.
Study entry of individual patients will be set apart by one week. Dosages of subsequent dose
groups depend on the incidence of DLTs in former groups.
For safety reasons the values of endotoxin content in Iscador®P, measured by the limulus
test, are considered as the real content of endotoxins although the mistletoe lectins are
cross reacting in this test. This leads to a maximum dose of 200 mg representing the upper
limit of this dose finding study.
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