Viral Therapy in Treating Patient With Refractory Liver Cancer or Advanced Solid Tumors
NCT01628640 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2025-07-03
Summary
This phase I trial studies the best dose and side effects of recombinant vesicular stomatitis virus expressing interferon beta in treating patients with liver cancer or solid tumors with lesions that have spread to other parts of the body and do not respond to treatment. The study virus has a gene inserted into it which will allow production of interferon beta, which is a substance that will restrict the spread of the virus to tumor cells and not healthy cells. It will also 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). Funding Source - FDA OOPD.
Conditions
- Advanced Malignant Solid Neoplasm
- Hepatocellular Carcinoma
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- OTHER
-
Pharmacological Study
Correlative studies
- BIOLOGICAL
-
Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta
Given intratumorally
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Mitesh J. Borad, M.D. · Mayo Clinic
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-03
- Primary Completion
- 2019-04-19
- Completion
- 2019-04-19
- FDA Drug
- Yes
Countries
- United States
Study Locations
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