Phase 2 Study of High Dose Ascorbic Acid in Solid Tumor Disease
Ascorbic acid has demonstrated selective cytotoxicity in cancer cells in vitro, while
sparing normal cells from its peroxidative effects. This study will examine the effect, if
any, of the drug when dosed in patients at a level sufficient to achieve transient serum
states of 400mg/dl. Safety of the drug has been shown in a Phase I study when dosed as high
as 1.5gm/kg. Patients will be treated twice weekly for 12 weeks (24-cycles) and evaluated
for response using RECIST criteria. Patients showing stable disease or objective response
will remain on study for up to one year or until absence of measurable disease or disease
progression.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of treatment
Efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by CT scan interpretation
12-weeks
No
G D Murphy, MD
Principal Investigator
Situs Cancer Research Center
United States: Institutional Review Board
L500HD
NCT01125449
January 2011
December 2014
Name | Location |
---|---|
Situs Cancer Research Center | Rogers, Arkansas 72756 |