Viral Therapy in Treating Patient with Liver Cancer
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 11-007114
NCT ID: NCT01628640
Sponsor Protocol Number: MC1148
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)
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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
- 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 us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Mitesh Borad, M.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office