Jefferson Health

A Study of Vitamin C in the Treatment of Metastatic Hepatocellular Carcinoma

IRB Protocol #: 12D.424

Description:

  • Ascorbic Acid (or Vitamin C) given intravenously elaborates high concentrations of hydrogen peroxide, which causes cell death to cancer cells; there is evidence that it can work in combination with several different chemotherapy agents. Preclinical data suggests that the higher the dose of Ascorbic Acid, the more hydrogen peroxide is generated with a higher potential for cell death.
  • The purpose of this clinical trial is to study an intravenous Vitamin C treatment for people with metastatic hepatocellular carcinoma, who are also receiving sorafenib, to see whether the combination treatment of ascorbic acid and sorafenib is safe and well tolerated. The goal is to utilize CT scans to assess overall tumor response rate as well as evaluate disease progression.
  • The study will take place at Thomas Jefferson University Hospital and will enroll up to 48 patients.

Procedure:

  • Intravenous Vitamin C treatments will be given three times per week for an initial period of 16 weeks.
  • Sorafenib will be taken twice by mouth on a daily basis.
  • These treatments and any standard diagnostic imaging procedures will be provided free of charge to the participant.

Inclusion Criteria:

  • Males or Females Age > 18
  • Persons with metastatic hepatocellular carcinoma (stage IV disease)
  • Cannot be pregnant or breastfeeding
  • Not enrolled in an active clinical trial/experimental therapy/IND study currently or within the last 30 days
  • Must receive treatment at Thomas Jefferson University Hospital

Contact Information:

Michael J. Matthews
215-503-7329
michael.matthews@jefferson.edu