Skip to Main Content Try our beta test site 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. Intervention Model: Single Group AssignmentMasking: Open LabelPrimary Purpose: Treatment A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors Drug Information available for: 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 ] July 2010 (Final data collection date for primary outcome measure) 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 (Adult, Senior) Sexes Eligible for Study: Primary histological diagnosis of advanced solid tumors (stage 3 and 4) and measurable disease. Disease must have progressed for which no available treatment provides clinical benefit. 18 years of age or older. No scheduled cancer therapy (chemotherapy, hormonal therapy, immune therapy, or radiation therapy) for three months after study entry, and the subject must have had their last therapy at least four (4) weeks prior to entry to this study. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Informed Consent - The patient must be willing and able to sign the informed consent prior to the start of the trial. Willingness to comply with the weekly phone calls between office visits. Willingness to undergo central line placement (e.g., port-a-catheter, central venous catheter, percutaneously inserted central catheter [PICC] line placement) and able to manage care of the entry site safely. Patients must be able to take food orally or have peg tube for feeding. Life expectancy of at least 3 months. Glucose-6-phosphate dehydrogenase deficiency (G6PD) (a relative contraindication) Renal insufficiency as evidenced by serum creatinine of ≥ 1.3 mg/dl or evidence of oxalosis by urinalysis. Iron overload (a ferritin > 500 ng/ml). Compromised liver function with evidence of complete biliary obstruction or have a serum bilirubin of 2.0 or liver function tests (AST > 63, ALT > 95) exceeding 1.5 x the upper limit of normal. Pregnant or lactating female.
Evidence of significant psychiatric disorder by history or examination that would prevent completion of the study or preclude informed consent. Aspirin use exceeding 325 mg per day. Acetaminophen use exceeding 2 g per day. Brain metastases that have not responded to therapy. Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. Please refer to this study by its ClinicalTrials.gov identifier: NCT00441207 CTCA @ Midwestern Regional Medical Center Zion, Illinois, United States, 60099 Midwestern Regional Medical Center Chris Stephenson, DO, Midwestern Regional Medical Center Other Study ID Numbers: Keywords provided by Midwestern Regional Medical Center:
Additional relevant MeSH terms: Physiological Effects of Drugs Molecular Mechanisms of Pharmacological Action Freedom of Information Act U.S. National Library of Medicine U.S. National Institutes of Health U.S. Department of Health and Human ServicesA 56 year old male was referred to Auckland Hospital ICU on 1 July 2009 with total respiratory failure, for ECMO external oxygenation. The patient had contracted H1N1 Swine flu (confirmed by tests) while on holiday overseas, and had developed what is known as ‘white out’ pneumonia. This refers to x-rays showing no air space in the lungs. After 20 days of life-sustaining ECMO treatment and other critical care, the patient, who was unconscious by induced coma, had not responded. The ICU team advised the family of the likely outcome and had prepared them for the possibility of the patient’s death. Family members approached Centre for Advanced Medicine Limited (CAM) for advice on the clinical use of intravenous vitamin C for such cases.
At the family’s request, information was provided to ICU doctors including ISO 9001:2008 registered protocols, safety data, dosages and access to vials of IV vitamin C under CAM’s license for wholesale medicines. The ICU team agreed to administer intravenous vitamin C according to the family’s wishes. This decision acknowledged the family’s rights, in compliance with the New Zealand Health and Disability Act, 1997. The patient received intravenous vitamin C starting on the evening of 21 July, continuing until 29 July. 25 grams was provided on the first day increasing over the first three days to 50 grams twice daily which was sustained for a further six days. By 24 July x-rays indicated increasing lung function and ECMO external oxygenation was discontinued on 26 July. After several days of assisted ventilation and critical care for ongoing secondary conditions, the patient was able to commence his recovery and rehabilitation. The patient was discharged from hospital on Friday 18 September, and is recovering at home on the farm.