Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754987
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date  ICMJE December 18, 2012
First Posted Date  ICMJE December 21, 2012
Results First Submitted Date  ICMJE June 25, 2018
Results First Posted Date  ICMJE August 23, 2018
Last Update Posted Date August 23, 2018
Study Start Date  ICMJE September 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
Number of Participants That Experience Serious Adverse Events. [ Time Frame: 16 weeks +/- 2 weeks ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Safety [ Time Frame: 16 weeks +/- 2 weeks ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Overall Tumor Response Rate [ Time Frame: 16 weeks +/- 2 weeks ]
    To utilize CT or PET/CT scans to assess overall tumor response rate (complete) in subjects with advanced metastatic hepatocellular cancer treated with the combination of ascorbic acid and sorafenib versus sorafenib alone.
  • Mean Value Collected Using the Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument [ Time Frame: 16 weeks +/- 2 weeks ]
    To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G will be summarized at multiple time points. Five-point scale from 0 (not at all) to 4 (very much)
  • Number of Participants That Are Alive After 15 Weeks of Treatment. [ Time Frame: 15 weeks+ ]
    To evaluate duration of tumor response and progression-free survival
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
  • Efficacy [ Time Frame: 16 weeks +/- 2 weeks ]
    To utilize CT or PET/CT scans to assess overall tumor response rate (complete and partial response) and evaluate disease progression in subjects with advanced metastatic hepatocellular cancer treated with the combination of ascorbic acid and sorafenib versus sorafenib alone.
  • Quality of Life [ Time Frame: 16 weeks +/- 2 weeks ]
    1) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations.
  • Survival [ Time Frame: 15 weeks+ ]
    To evaluate duration of tumor response, progression-free survival and quality of life related to treatment of patients with metastatic hepatocellular carcinoma (advanced liver cancer)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective
Official Title  ICMJE Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Hepatocellular Carcinoma
  • Advanced Liver Cancer
Intervention  ICMJE
  • Drug: Ascorbic Acid + Sorafenib
    Other Names:
    • Vitamin C
    • Ascorbate
  • Drug: Sorafenib
    Other Name: Nexavar
Study Arms  ICMJE
  • Experimental: 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)

    Intervention: Drug: Ascorbic Acid + Sorafenib
  • Sorafenib alone
    Sorafenib: taken daily (oral)
    Intervention: Drug: Sorafenib
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2017)
5
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
48
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754987
Other Study ID Numbers  ICMJE 12D.424
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel A Monti, MD, MBA Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP