A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective
Conditions
Metastatic Hepatocellular Carcinoma - Advanced Liver Cancer
Conditions: official terms
Carcinoma, Hepatocellular - Liver Neoplasms
Conditions: Keywords
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
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Ascorbic Acid + Sorafenib Type: Drug
Name: Sorafenib alone Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Location
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Status: Recruiting
Contact: Daniel A Monti, MD - 215-955-4410 - daniel.monti@jefferson.edu
Start Date
September 2012
Completion Date
September 2015
Sponsors
Thomas Jefferson University
Source
Thomas Jefferson University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page