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

NCT ID: NCT01754987

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2016-01-31

Brief 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

Detailed 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.

Conditions

Metastatic Hepatocellular Carcinoma; Advanced Liver Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ascorbic Acid + Sorafenib

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)

Group Type: EXPERIMENTAL

Ascorbic Acid + Sorafenib

Intervention Type: DRUG

Sorafenib alone

Sorafenib: taken daily (oral)

Group Type: OTHER

Sorafenib

Intervention Type: DRUG

Interventions

Ascorbic Acid + Sorafenib

Intervention Type: DRUG

Sorafenib

Intervention Type: DRUG

Other Intervention Names

Vitamin C; Ascorbate; Nexavar

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel A Monti, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Countries

United States

References

Monti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17.

Reference Type: BACKGROUND

PMID: 22272248 (View on PubMed)

Other Identifiers

JT 2306

Identifier Type: OTHER

Identifier Source: secondary_id

12D.424

Identifier Type: -

Identifier Source: org_study_id