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.
Verified December 2012 by Thomas Jefferson University
Sponsor:
Thomas Jefferson University
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01754987
First received: December 18, 2012
Last updated: December 21, 2012
Last verified: December 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2014 |
| 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:
|
|
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
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: | December 21, 2012 |
| 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:
|
Carcinoma Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Adenocarcinoma Sorafenib Antineoplastic Agents Antineoplastic Agents, Phytogenic |
Ascorbic Acid Vitamins Radiation-Sensitizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Therapeutic Uses Pharmacologic Actions Antioxidants Protective Agents Micronutrients Growth Substances Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013