The study is designed to determine if high doses of intravenous ascorbic acid (vitamin C) can be effective in managing solid tumor diseases. Secondary goals are determination of any palliative effects and improvement of quality of life of patients.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Intravenous administration of up to 1.5gm/kg of ascorbic acid, twice weekly for up to 12-weeks.
Situs Cancer Research Center
Rogers, Arkansas, United States
Efficacy of treatment
Survival as a result of efficacy of treatment will be evaluated at 12-weeks. Efficacy is evaluated using RECIST criteria to determine disease response by PET/CT scan interpretation, lab studies and current good clinical practice methodologies for solid tumor interventional treatment.
Time frame: 12-weeks
Patient self-assessment of Quality of Life at 12-weeks
Quality of life during treatment will be measured using FACT questionnaires.
Time frame: 12-weeks
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