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

Cancer Clinical Trial

Official title:

A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441207
• Other study ID #: CTCA 06-04
• Secondary ID: Ascorbic Acid In
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2007
• Last updated: April 22, 2013
• Start date: August 2006
• Est. completion date: July 2010

Study information

• Verified date: April 2013
• Source: Midwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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, ability to do things, and quality of life, before and after vitamin C is given.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Ascorbic Acid
Delivered via IV Infusion.

Locations

Country	Name	City	State
United States	CTCA @ Midwestern Regional Medical Center	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety and tolerability of high dose IV vitamin C as a monotherapy		1-1/2 years	Yes
Primary	Evaluate the pharmacokinetic profile of IV vitamin C at varying doses		1-1/2 years	Yes
Secondary	Determine if vitamin C accumulates with repeated daily therapy by measuring peak and nadir levels		1 year	Yes
Secondary	Evaluate patient quality of life		Duration of Study	Yes
Secondary	Observe patients for clinical and radiological evidence of anti-tumor activity at the end of treatment		Duration of Study	No