Trials / Completed
CompletedNCT01754987
A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective
Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Thomas Jefferson University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with sorafenib versus treatment with sorafenib alone in subjects with metastatic hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to assess overall tumor response rate and evaluate disease progression
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ascorbic Acid + Sorafenib | |
| DRUG | Sorafenib |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2016-01-01
- Completion
- 2016-01-01
- First posted
- 2012-12-21
- Last updated
- 2025-05-04
- Results posted
- 2018-08-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01754987. Inclusion in this directory is not an endorsement.