Study of High-Dose Intravenous (IV) Vitamin C Treatment in Patients With Solid Tumors
|ClinicalTrials.gov Identifier: NCT00441207|
Recruitment Status : Completed
First Posted : February 28, 2007
Last Update Posted : April 23, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Ascorbic Acid||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors|
|Study Start Date :||August 2006|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
Drug: Ascorbic Acid
- Evaluate the safety and tolerability of high dose IV vitamin C as a monotherapy [ Time Frame: 1-1/2 years ]
- Evaluate the pharmacokinetic profile of IV vitamin C at varying doses [ Time Frame: 1-1/2 years ]
- Determine if vitamin C accumulates with repeated daily therapy by measuring peak and nadir levels [ Time Frame: 1 year ]
- Evaluate patient quality of life [ Time Frame: Duration of Study ]
- Observe patients for clinical and radiological evidence of anti-tumor activity at the end of treatment [ Time Frame: Duration of Study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441207
|United States, Illinois|
|CTCA @ Midwestern Regional Medical Center|
|Zion, Illinois, United States, 60099|
|Principal Investigator:||Christopher Lis||Midwestern Regional Medical Center|