Phase I Assay-guided Trial of Anti-inflammatory Phytochemicals in Patients With Advanced Cancer
This study will look at oligomeric procyanidin complex (OPC) and vitamin D3. OPC is the
major part of Grape Seed Extract (GSE). Researchers are in looking at the combination of GSE
and vitamin D in subjects with solid cancers (gastrointestinal, lung, breast, prostate,
lymphoma or cancer of the lymph nodes). Researchers will examine the safety of the GSE and
vitamin D when GSE is given at different doses. Researchers will also look at the effects of
GSE and vitamin D on your quality of life and your body. In particular, they will look at
differences in biomarkers in your blood and urine.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximally-tolerated dose of Grape Seed Extract in Patients with Solid Tumors
Decisions to escalate or expand a dose level will be based only on the GSE-only treatment period (day 1-21). To be evaluable for toxicity, a patient must receive at least 3 weeks of GSE treatment, or have experienced dose-limiting toxicity (DLT). All patients enrolled are to be fully followed for toxicity, but any patients who are not evaluable for toxicity will be replaced.
Michael Lilly, MD
Medical University of South Carolina
United States: Food and Drug Administration
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|