A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with sorafenib versus treatment with sorafenib alone in subjects with metastatic hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to assess overall tumor response rate and evaluate disease progression

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Ascorbic Acid; Molecular Mechanisms of Pharmacological Action; Niacinamide; Sorafenib; Vitamins

Criteria

Inclusion Criteria:

• Age > 18 years

• Metastatic hepatocellular carcinoma

• G6PD (glucose-6-phosphate dehydrogenase) status > lower limit of normal

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

• Laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5X upper limit (if the creatinine is elevated, but ≤1.5X the ULN, a 24 hour creatinine clearance will be obtained); transaminase (AST/ALT) ≤2.0X upper limit of normal; bilirubin levels ≥ 2 mg/dL; ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥ 100,000/mm3

• Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the study.

• Willing and able to provide informed consent and participate in the study procedures.

Exclusion Criteria:

• Patients with evidence of a significant current psychiatric disorder that would prevent completion of the study as determined by the PI will not be allowed to participate.

• Co-morbid medical condition that would affect survival or tolerance as determined by the PI. This includes patients who have not fully recovered from toxicities associated with prior therapy. It also includes subjects who, as determined by the PI, are at risk of experiencing fluid overload (i.e., congestive heart failure).

• Patients who currently abuse alcohol or drugs.

• Patients with known glomerular filtration rate of <60ml/min or with nephrotic range proteinuria.

• Pregnant or lactating women

• Enrollment in active clinical trial/ experimental therapy or IND study within the prior 30 days.

• Contraindication for CT or PET/CT as per the PI.