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

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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Metastatic Hepatocellular Carcinoma Advanced Liver Cancer Drug: Ascorbic Acid + Sorafenib Drug: Sorafenib Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma
Study Start Date : September 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
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)

 Drug: Ascorbic Acid + Sorafenib
Other Names:
  • Vitamin C
  • Ascorbate
Sorafenib alone
Sorafenib: taken daily (oral)
 Drug: Sorafenib
Other Name: Nexavar


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754987


Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Daniel A Monti, MD, MBA Thomas Jefferson University
More Information
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Publications:

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01754987     History of Changes
Other Study ID Numbers: 12D.424
First Posted: December 21, 2012    Key Record Dates
Results First Posted: August 23, 2018
Last Update Posted: August 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Thomas Jefferson University:
Vitamins
Malignant Tumor, Tumour
Integrative Medicine
Complementary Medicine
Alternative Medicine Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
 Physiological Effects of Drugs
Micronutrients
Growth Substances
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Liver Cancer

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Vitamins
Niacinamide
 Ascorbic Acid
Sorafenib
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Micronutrients
Growth Substances
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Antioxidants
Protective Agents