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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00441207
Recruitment Status : Completed
First Posted : February 28, 2007
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
Chris Stephenson, Midwestern Regional Medical Center

Study Description
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Brief Summary:

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors
Study Start Date : August 2006
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arms and Interventions
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Intervention Details:
  • Drug: Ascorbic Acid
    Delivered via IV Infusion.

Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the safety and tolerability of high dose IV vitamin C as a monotherapy [ Time Frame: 1-1/2 years ]
  2. Evaluate the pharmacokinetic profile of IV vitamin C at varying doses [ Time Frame: 1-1/2 years ]

Secondary Outcome Measures :
  1. Determine if vitamin C accumulates with repeated daily therapy by measuring peak and nadir levels [ Time Frame: 1 year ]
  2. Evaluate patient quality of life [ Time Frame: Duration of Study ]
  3. Observe patients for clinical and radiological evidence of anti-tumor activity at the end of treatment [ Time Frame: Duration of Study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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United States, Illinois
CTCA @ Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
Sponsors and Collaborators
Midwestern Regional Medical Center
Investigators
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Principal Investigator: Christopher Lis Midwestern Regional Medical Center
More Information
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Responsible Party: Chris Stephenson, DO, Midwestern Regional Medical Center
ClinicalTrials.gov Identifier: NCT00441207    
Other Study ID Numbers: CTCA 06-04
Ascorbic Acid Injection
First Posted: February 28, 2007    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013
Keywords provided by Chris Stephenson, Midwestern Regional Medical Center:
IV Ascorbic Acid
IV Vitamin C
Cancer
Advanced Solid Tumors
Additional relevant MeSH terms:
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Ascorbic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
 Physiological Effects of Drugs
Vitamins
Micronutrients