A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors
18 Years
N/A
Both
Cancer
Trial Information
A Phase I Study of High-Dose IV Vitamin C Treatment in Patients With Solid Tumors
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluate the safety and tolerability of high dose IV vitamin C as a monotherapy
Outcome Time Frame:
1-1/2 years
Safety Issue:
Yes
Principal Investigator
Christopher Lis
Investigator Role:
Principal Investigator
Investigator Affiliation:
Midwestern Regional Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
CTCA 06-04
NCT ID:
NCT00441207
Start Date:
August 2006
Completion Date:
July 2010
Related Keywords:
- Cancer
- IV Ascorbic Acid
- IV Vitamin C
- Cancer
- Advanced Solid Tumors
Name | Location |
|---|---|
| CTCA @ Midwestern Regional Medical Center | Zion, Illinois 60099 |
