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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01754987
First received: December 18, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Metastatic Hepatocellular Carcinoma
Advanced Liver Cancer
Drug: Ascorbic Acid + Sorafenib
Drug: Sorafenib alone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Safety [ Time Frame: 16 weeks +/- 2 weeks ] [ Designated as safety issue: Yes ]
    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:
  • Efficacy [ Time Frame: 16 weeks +/- 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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+ ] [ Designated as safety issue: No ]
    To evaluate duration of tumor response and progression-free survival


Estimated Enrollment: 48
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 alone

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754987

Contacts
Contact: Michael Matthews 215-503-7329 michael.matthews@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Daniel A Monti, MD    215-955-4410    daniel.monti@jefferson.edu   
Principal Investigator: Daniel A Monti, MD         
Sub-Investigator: Susan J Littman, MD         
Sub-Investigator: Edith P Mitchell, MD         
Sub-Investigator: Nancy Lewis, MD         
Sub-Investigator: Madhavan Pillai, MD         
Sub-Investigator: Anthony J Bazzan, MD         
Sub-Investigator: Andrew B Newberg, MD         
Sponsors and Collaborators
Thomas Jefferson University
  More Information

Publications:
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01754987     History of Changes
Other Study ID Numbers: 12D.424
Study First Received: December 18, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board

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:
Ascorbic Acid
Carcinoma, Hepatocellular
Liver Neoplasms
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Vitamins
Sorafenib
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Antioxidants
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014