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

No results posted yet for this study

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

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
  • Mayo Clinic

    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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01628640 on ClinicalTrials.gov