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

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

Clinical Trials