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

Sponsor:	Cancer Treatment Centers of America
Information provided by:	Cancer Treatment Centers of America
ClinicalTrials.gov Identifier:	NCT00441207

Purpose

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
Cancer	Drug: Ascorbic Acid	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Vitamin C

Drug Information available for: Ascorbic acid

U.S. FDA Resources

Further study details as provided by Cancer Treatment Centers of America:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	18
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Delivered via IV Infusion.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Chronic hemodialysis.
Iron overload (a ferritin > 500 ng/ml).
Wilson's disease.
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.
Current tobacco use.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441207

Locations

United States, Illinois
CTCA @ Midwestern Regional Medical Center
Zion, Illinois, United States, 60099

Sponsors and Collaborators

Cancer Treatment Centers of America

More Information

No publications provided

Responsible Party:	Robert Levin, MD., Christopher Stephenson, MD., Christopher Lis, MPH., ctca
ClinicalTrials.gov Identifier:	NCT00441207 History of Changes
Other Study ID Numbers:	CTCA 06-04, Ascorbic Acid Injection
Study First Received:	February 26, 2007
Last Updated:	June 24, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cancer Treatment Centers of America:

IV Ascorbic Acid
IV Vitamin C
Cancer
Advanced Solid Tumors

Additional relevant MeSH terms:

Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 12, 2012