Viral Therapy in Treating Patient with Liver Cancer

Overview

About this study

The primary purpose of this study is to evaluate the safety of a viral agent called vesicular stomatitis virus for the use in patients with liver cancer. The study virus has a gene inserted into it which will allow for the production of interferon beta, which is a substance that will have the dual functions of restricting the spread of the virus to the tumor cells and not healthy liver cells and also to have some independent anti-cancer activity. Although the primary goal of this study is to evaluate the safety of delivery of this viral agent to people, patients may benefit clinically by having shrinkage or stabilization of their tumor or reduction in their cancer related symptoms (e.g. pain)

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Histologically or cytologically confirmed hepatocellular carcinoma that is refractory to or intolerant of sorafenib based therapy
  • Absolute neutrophil count (ANC) ≥ 1000/mm^3
  • Platelet count ≥ 80,000/mm^3
  • Hemoglobin ≥ 10 g/dl
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) &l; 5 times upper limit of normal
  • Creatinine within institutional limits of normal
  • Total bilirubin ≤ 3 x upper limit of normal (ULN)
  • International normalized ratio (INR) ≤ 1.4 x ULN
  • Activated partial thromboplastin time (aPTT) within institutional limits of normal
  • Ability to provide informed written consent
  • Willingness to return to Mayo Clinic in Arizona for follow-up
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Willingness to provide all biological specimens as required by the protocol
  • Negative serum pregnancy test ≤ 7 days prior to registration for women of childbearing potential only
  • Child Pugh Score A or B7
  • The patient and their partner agree to use a barrier method of contraception during the study and 4 months following end of active treatment

Exclusion Criteria:

  • Uncontrolled infection
  • Systemic anti-cancer therapy ≤ 4 weeks prior to registration
  • Known human immunodeficiency virus (HIV) infection
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy
  • Pregnant or nursing women
  • History of bone marrow or solid organ transplantation
  • Patient for whom surgical resection or liver transplantation would be more appropriate
  • Any condition, which in the opinion of the investigator would render the patient unsuitable to participate in the study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mitesh Borad, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

Mayo Clinic Footer