drugset / Trial / NCT01129570

Siliphos in Advanced Hepatocellular Carcinoma

NCT01129570

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Milk thistle is an herbal drug that may have some liver protection properties and may reduce inflammation in the liver. It may also have anticancer effects. However milk thistle is not approved by the Food and Drug Administration for any medical purpose in the United States. It has not been used in patients with liver cancer previously, to our knowledge, but there have been many studies of its use in patients with hepatitis and cirrhosis. Some of these studies have shown that milk thistle may help reduce elevated liver function tests. Siliphos is a derivative of milk thistle that can be absorbed better than some other types of milk thistle. The investigators would like to perform a study to identify doses of siliphos that are safe to take in advanced liver cancer and to identify positive or negative side effects this compound may have. The investigators will be using this information in future studies to see if siliphos can be used as a therapy in patients with advanced liver cancer to reduce elevated liver function tests.

Timeline

Start
2010-02
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Silymarin Traditional medicine (herbal / TCM) 2 g
Subject Silymarin Traditional medicine (herbal / TCM) 4 g
Subject Silymarin Traditional medicine (herbal / TCM) 8 g
Subject Silymarin Traditional medicine (herbal / TCM) 12 g