New investigational drug for hepatocellular carcinoma.

Trial ID:
IRB-13-6150
Catherine Frenette, MD
The purpose of this study is to test a new drug called ADI-PEG 20 in patients with liver cancer (hepatocellular carcinoma). The sponsor would like to see what effects, good and/or bad, it has on the patient and liver cancer. There have already been four studies in which liver cancer patients have received this drug and some people have had their tumors shrink. In addition, some patients lived longer than they would have been anticipated to live. Also, most patients experienced few side effects. Thus the drug has typically been well tolerated.<br><br>

Inclusion Criteria

  • 1. Have a prior diagnosis of HCC confirmed histologically or cytologically.
  • 2. Have had prior treatment with at least 1 systemic agent, with documented PD after systemic agent(s), or AEs associated with prior systemic agent(s) that resulted in discontinuance of that agent(s).
  • 3. Have measurable disease using RECIST 1.1 criteria. At least one measurable lesion must be present.
  • 4. Have a cirrhotic status of Child-Pugh grade A and B7.
  • 5. Have an expected survival of at least 3 months.
  • 6. Be = 18 years.
  • 7. Have had no prior systemic treatment for HCC in the last 2 weeks prior to first dose of study drug or placebo.
  • 8. Be fully recovered from prior major surgery and none within 2 weeks prior to first dose of study drug or placebo. Liver biopsy for HCC confirmation is allowed.
  • 9. Use use appropriate contraception, both the male and female, for the duration of the study.
  • 10. Read and sign informed consent prior to study initiation.
  • 11. Not be on any concurrent investigational st

Exclusion Criteria

  • 1. Be a candidate for potential curative therapies (i.e., resection or transplantation) or locoregional
  • approaches (i.e., ablation, embolization).
  • 2. Have had prior allograft transplantation including liver transplantation.
  • 3. Have significant cardiac disease (New York Heart Association Class III or IV.
  • 4. Have serious infection requiring treatment with systemically administered antibiotics.
  • 5. Be pregnant or lactating.
  • 6. Have expected non-compliance.
  • 7. Have uncontrolled intercurrent illness that would limit compliance with study requirements.
  • 8. Have had any anticancer treatment within 2 weeks prior to first dose of study drug or placebo.
  • 9. Have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies.
  • 10. Have a history of another primary cancer, but there are exceptions.
  • 11. Have been treated with ADI-PEG 20 previously.
  • 12. Have allergy to pegylated products.
  • 13. Have a history of seizure disorder.
  • 14. Have bleeding esoph

Contact Info:

  • Gail Moore, RN
  • moore.gail@scrippshealth.org
  • 858-652-5442