Cancer Clinical Trial
Official title:
A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors
The primary purpose of this study is to evaluate the safety and tolerability of vitamin C
(ascorbic acid) given by injection into the vein.
The second and third purpose of conducting this study is to observe any evidence of tumor
response to the vitamin C and compare the level of fatigue (weakness), pain control, ability
to do things, and quality of life, before and after vitamin C is given.
Preclinical studies of pharmacologic doses of vitamin C (ascorbic acid, ascorbate) have
shown significant anticancer effects in animal models and tissue culture investigations
including cytotoxic effects in certain cancer cell lines at micromolar to millimolar
concentrations.
Early clinical studies have shown that intravenous and oral doses of vitamin C may improve
symptoms and prolong survival in terminal cancer patients. More recent double-blind
placebo-controlled studies have shown that oral adminstration of vitamin C provides no
benefit to cancer patients. Conversely, intravenous vitamin C administration raises plasma
concentrations as high as 14 mM/L, and concentrations of 1-5 mM/L have been found to be
selectively cytoxic to tumor cells in vitro.
The proposed Phase I trial with vitamin C should achieve millimolar concentrations of
vitamin C that have been shown to kill tumor cells in vitro. The maximum tolerated dose
(MTD), PK, possible drug accumulation with repeated dosing, quality of life, pain response,
fatigue status, and hints of efficacy in patients with advanced cancer will be examined.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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