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ACTIVE NOT RECRUITING
NCT03120624
PHASE1

VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving VSV-hIFNbeta-NIS with ruxolitinib phosphate may work better in treating patients with endometrial cancer compared to VSV-hIFNbeta-NIS alone.

Official title: Phase I Trial of Intravenous Administration of Vesicular Stomatitis Virus Genetically Engineered to Express Thyroidal Sodium Iodide Symporter (NIS) and Human Interferon Beta (hIFNb), in Patients With Metastatic or Recurrent Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2017-09-15

Completion Date

2028-01-01

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy

Undergo image-guided biopsy

PROCEDURE

Computed Tomography

Undergo CT

OTHER

Fluorine F 18 Tetrafluoroborate

Given IV

OTHER

Pharmacological Study

Correlative studies

PROCEDURE

Positron Emission Tomography

Undergo TFB-PET

BIOLOGICAL

Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter

Given IV

DRUG

Ruxolitinib Phosphate

Given PO

DRUG

Technetium Tc-99m Sodium Pertechnetate

Given IV

PROCEDURE

Biospecimen Collection

Undergo mouth rinse, buccal swab, urine, and blood sample collection

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States