Know Cancer

or
forgot password

Pharmacokinetic Evaluation of Intravenous Ascorbic Acid


Phase 1
21 Years
N/A
Open (Enrolling)
Both
Safety and Pharmacokinetics of Intravenous Ascorbate

Thank you

Trial Information

Pharmacokinetic Evaluation of Intravenous Ascorbic Acid


The purpose of this study is to examine what happens when Vitamin C enters into the body,
and the speed and ways it travels through the body, and the rate at which it exits the body
in the urine. It is also necessary to determine if it is safe to give Intravenous Vitamin C
at high doses.

Inclusion Criteria


PART 1 ELIGIBILITY CRITERIA

Inclusion:

- Healthy adults age 21 or older

- Laboratory: ANC ≥1,500/mm3,

- Hemoglobin > 8g/dL,

- platelet ≥ 100,000/mm3,

- total bilirubin ≤ 1.5 mg/dL,

- creatinine ≤2.0 mg/dL,

- transaminase (AST/ALT) ≤2.5X upper limit,

- urine uric acid < 1,000mg/d,

- urine pH <6,

- urine oxalate <60 mg/d.

- Participants who have no language barrier, are cooperative, and can give informed
consent before entering the study after being informed of the medications and
procedures to be used in this study may participate.

Exclusion:

- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency

- History of bleeding disorder

- History of oxalate renal calculi; urine oxalate level > 60 mg/d at baseline

- History of iron overload or hemochromatosis

- Participants with evidence of a significant psychiatric disorder by
history/examination that would prevent completion of the study will not be allowed to
participate.

- Co-morbid condition that would affect survival: end stage congestive heart failure,
unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood
sugars ≥ 300 mg/dL, participants with known chronic active hepatitis or cirrhosis.

- Participants who consume an excess of alcohol or abuse drugs (an excess of alcohol is
defined as more than four of any one of the following per day: 30mL distilled
spirits, 340mL beer, or 120mL wine) will not be allowed.

- Participants who smoke tobacco products will not be allowed to participate.

PART 2 ELIGIBILITY CRITERIA

Inclusion:

- Oncology participants must have histologically or cytologically diagnosed malignancy.

- The oncology participants must be age 21 or older and screened for eligibility and
have study approved by treating oncologist.

- Oncology participants must be unwilling or ineligible for further radiation or
chemotherapy at the time of enrollment into study.

- Participants must be without evidence of active spinal cord compression and have
predicted lifespan of 6-months or more.

- ECOG Performance Status 0-2

- Eastern Cooperative Oncology Group Performance Status

- Grade 0 = Fully active, able to carry on all pre-disease activities without
restriction

- Grade 1= Restricted in physical strenuous activity but ambulatory and able to
carry out work of a light or sedentary nature e.g. light housework, office work

- Grade 2 = Ambulatory and capable of all self care but unable to carry out any
work activities. Up and about more than 50% of waking hours.

- Laboratory:

- ANC ≥1,500/mm3,

- Hemoglobin > 8g/dL,

- platelet ≥ 100,000/mm3,

- total bilirubin ≤ 1.5 mg/dL,

- creatinine ≤2.0 mg/dL,

- transaminase (AST/ALT) ≤2.5X upper limit,

- urine uric acid < 1,000mg/d, urine pH <6,

- urine oxalate <60 mg/d.

- Participants who have no language barrier, are cooperative, and can give informed
consent before entering the study after being informed of the medications and
procedures to be used in this study may participate.

Exclusion:

- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency

- Currently receiving chemotherapy or radiation therapy

- History of bleeding disorder

- History of oxalate renal calculi; urine oxalate level > 60 mg/d at baseline

- History of iron overload or hemochromatosis

- Participants with evidence of a significant psychiatric disorder by
history/examination that would prevent completion of the study will not be allowed to
participate.

- ECOG Performance Status of 3-4

- Grade 3 = Capable of only limited self care, confined to bed or chair more than
50% of waking hours.

- Grade 4 = Completely disabled. Cannot carry on any self care. Totally confined
to bed or chair) and in terminal stages of disease.

- Co-morbid condition that would affect survival: end stage congestive heart failure,
unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood
sugars ≥ 300 mg/dL, participants with known chronic active hepatitis or cirrhosis.

- Those who consume an excess of alcohol or abuse drugs (an excess of alcohol is
defined as more than four of any one of the following per day: 30mL distilled
spirits, 340mL beer, or 120mL wine) will not be allowed.

- Those who smoke tobacco products will not be allowed to participate.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

identify the maximum tolerated dose (MTD)

Outcome Description:

This will be accomplished by obtaining the following evaluations: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, ECG, basic metabolic panel, bicarbonate (pH surrogate marker), CBC, and osmolality.

Outcome Time Frame:

Change from infusion to 24 hours past infusion

Safety Issue:

Yes

Principal Investigator

Jeanne Drisko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Food and Drug Administration

Study ID:

12680

NCT ID:

NCT01833351

Start Date:

May 2011

Completion Date:

May 2013

Related Keywords:

  • Safety and Pharmacokinetics of Intravenous Ascorbate
  • Phase I
  • safety and pharmacokinetics,
  • intravenous ascorbate,
  • IV Vitamin C,
  • Oncology

Name

Location

University of Kansas Medical Center Kansas City, Kansas  66160-7353