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Sponsored by: |
Cancer Treatment Centers of America |
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Information provided by: | Cancer Treatment Centers of America |
ClinicalTrials.gov Identifier: | NCT00441207 |
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 | Intervention | Phase |
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Cancer |
Drug: Ascorbic Acid |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors |
Estimated Enrollment: | 18 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2009 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathleen Katrenick | 847-342-7475 | kathleen.katrenick@ctca-hope.com |
Contact: Candi Pfeiffer, RN | 847-872-4015 | candi.pfeiffer@ctca-hope.com |
United States, Illinois | |
CTCA @ Midwestern Regional Medical Center | Recruiting |
Zion, Illinois, United States, 60099 | |
Principal Investigator: Christopher M Stephenson, DO | |
Principal Investigator: Robert D. Levin, MD | |
Principal Investigator: Christopher G. Lis, MPH |
Study ID Numbers: | CTCA 06-04, Ascorbic Acid Injection |
Study First Received: | February 26, 2007 |
Last Updated: | August 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00441207 |
Health Authority: | United States: Food and Drug Administration |
IV Ascorbic Acid IV Vitamin C Cancer Advanced Solid Tumors |
Ascorbic Acid |
Antioxidants Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |