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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Midwestern Regional Medical Center
• Treatments: Ascorbic Acid; Vitamins

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.