NCT00441207

Study of High-Dose Intravenous (IV) Vitamin C Treatment in Patients With Solid Tumors

A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Midwestern Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Ascorbic Acid	Delivered via IV Infusion.

Timeline

• Start date: 2006-08-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2007-02-28
• Last updated: 2013-04-23

Locations

1 site across 1 country: United States