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

Metastatic Hepatocellular Carcinoma Clinical Trial

Official title:

Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754987
• Other study ID #: 12D.424
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2012
• Est. completion date: January 2016

Study information

• Verified date: July 2018
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Liver Cancer
• Carcinoma
• Carcinoma, Hepatocellular
• Liver Neoplasms
• Metastatic Hepatocellular Carcinoma

Intervention

Drug:
• Ascorbic Acid + Sorafenib

• Sorafenib

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants That Experience Serious Adverse Events.	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	16 weeks +/- 2 weeks
Secondary	Overall Tumor Response Rate	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.	16 weeks +/- 2 weeks
Secondary	Mean Value Collected Using the Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument	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)	16 weeks +/- 2 weeks
Secondary	Number of Participants That Are Alive After 15 Weeks of Treatment.	To evaluate duration of tumor response and progression-free survival	15 weeks+