A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective
Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma
2 other identifiers
interventional
5
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
December 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
August 23, 2018
CompletedMay 4, 2025
May 1, 2025
3.3 years
December 18, 2012
June 25, 2018
May 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants That Experience Serious Adverse Events.
The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with sorafenib therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE)v4.0
16 weeks +/- 2 weeks
Secondary Outcomes (3)
Overall Tumor Response Rate
16 weeks +/- 2 weeks
Mean Value Collected Using the Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument
16 weeks +/- 2 weeks
Number of Participants That Are Alive After 15 Weeks of Treatment.
15 weeks+
Study Arms (2)
Ascorbic Acid + Sorafenib
EXPERIMENTALDrug: 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)
Sorafenib alone
OTHERSorafenib: taken daily (oral)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Publications (1)
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.
PMID: 22272248BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Daniel Monti
- Organization
- Sidney Kimmel Cancer Center at Thomas Jefferson University
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel A Monti, MD, MBA
Thomas Jefferson University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2012
First Posted
December 21, 2012
Study Start
September 1, 2012
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
May 4, 2025
Results First Posted
August 23, 2018
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share