Study of High-Dose Intravenous (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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors|
- Evaluate the safety and tolerability of high dose IV vitamin C as a monotherapy [ Time Frame: 1-1/2 years ] [ Designated as safety issue: Yes ]
- Evaluate the pharmacokinetic profile of IV vitamin C at varying doses [ Time Frame: 1-1/2 years ] [ Designated as safety issue: Yes ]
- Determine if vitamin C accumulates with repeated daily therapy by measuring peak and nadir levels [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Evaluate patient quality of life [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]
- Observe patients for clinical and radiological evidence of anti-tumor activity at the end of treatment [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Drug: Ascorbic Acid
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.
|United States, Illinois|
|CTCA @ Midwestern Regional Medical Center|
|Zion, Illinois, United States, 60099|
|Principal Investigator:||Christopher Lis||Midwestern Regional Medical Center|