Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma
Intravenous Ascorbic Acid (Vitamin C) is a widely used alternative cancer treatment. This
trial will study an intravenous Vitamin C treatment for persons with liver cancer that has
spread, who are also receiving Sorafenib (a standard cancer drug), to see whether the
combination of Vitamin C and Sorafenib is safe and well tolerated. Phase I will involve 6
persons who will receive the Vitamin C for 8 weeks to more specifically assess the safety of
getting Vitamin C in combination with Sorafenib. Phase II will be randomized to receive
either Vitamin C plus Sorafenib or Sorafenib alone for 16 weeks. If Vitamin C has a
beneficial effect on tumour cells, patients may experience a regression of tumor or tumor
markers. Additional benefits include scans at no charge to the patient.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety
The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with sorafenib therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE)v4.0
16 weeks +/- 2 weeks
Yes
United States: Food and Drug Administration
12D.424
NCT01754987
September 2012
September 2014
Name | Location |
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Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |