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

Thomas Jefferson University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metastatic Hepatocellular Carcinoma; Advanced Liver Cancer

Treatments: Drug: Ascorbic Acid + Sorafenib; Drug: Sorafenib

Study type: Interventional

Funder types: Other

Identifiers

NCT01754987

JT 2306 (Other Identifier)

12D.424

Details and patient eligibility

About

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

Full description

Intravenous Ascorbic Acid (Vitamin C) is a widely used alternative cancer treatment. This trial will study an intravenous Vitamin C treatment for persons with liver cancer that has spread, who are also receiving Sorafenib (a standard cancer drug), to see whether the combination of Vitamin C and Sorafenib is safe and well tolerated. Phase I will involve 6 persons who will receive the Vitamin C for 8 weeks to more specifically assess the safety of getting Vitamin C in combination with Sorafenib. Phase II will be randomized to receive either Vitamin C plus Sorafenib or Sorafenib alone for 16 weeks. If Vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Ascorbic Acid + Sorafenib

Experimental group

Description:

Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate Dosage: Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)

Treatment:

Drug: Ascorbic Acid + Sorafenib

Sorafenib alone

Other group

Description:

Sorafenib: taken daily (oral)

Treatment:

Drug: Sorafenib