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CancerPhase 1NCT00441207

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

A Phase 1 study testing Ascorbic Acid in people with Cancer, run by Midwestern Regional Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
Ascorbic Acid
Type of treatment
Injection or infusion
How many people
18 participants
Where
1 siteUnited States
Study dates
Aug 2006to Jul 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • CTCA @ Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

About this study

Official title: A Phase I Study of High-Dose 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.

Read the 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.

Conditions
Cancer
Being tested
Ascorbic Acid
Keywords
IV Ascorbic Acid, IV Vitamin C, Cancer, Advanced Solid Tumors
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ascorbic AcidDrug

    Delivered via IV Infusion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety and tolerability of high dose IV vitamin C as a monotherapy

    Measured: 1-1/2 years

  2. Evaluate the pharmacokinetic profile of IV vitamin C at varying doses

    Measured: 1-1/2 years

Secondary outcomes (3)

  1. Determine if vitamin C accumulates with repeated daily therapy by measuring peak and nadir levels

    Measured: 1 year

  2. Evaluate patient quality of life

    Measured: Duration of Study

  3. Observe patients for clinical and radiological evidence of anti-tumor activity at the end of treatment

    Measured: Duration of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2007 (estimated)
  2. Study startAug 2006
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00441207
Sponsor's protocol ID
CTCA 06-04
Other IDs
Ascorbic Acid Injection
Status last verified
Apr 2013
First submitted
26 Feb 2007
Last updated
23 Apr 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ascorbic Acid in people with Cancer, run by Midwestern Regional Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety and tolerability of high dose IV vitamin C as a monotherapy (time frame: 1-1/2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00441207.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.

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