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

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.

Conditions

• Metastatic Endometrial Carcinoma
• Recurrent Endometrial Adenocarcinoma
• Recurrent Endometrial Carcinoma
• Recurrent Endometrial Clear Cell Adenocarcinoma
• Recurrent Endometrial Endometrioid Adenocarcinoma
• Recurrent Endometrial Mixed Cell Adenocarcinoma
• Recurrent Endometrial Serous Adenocarcinoma
• Recurrent Endometrial Undifferentiated Carcinoma
• Recurrent Uterine Corpus Carcinosarcoma
• Stage IV Uterine Corpus Cancer AJCC v7

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Jamie N. Bakkum-Gamez, M.D. · Mayo Clinic in Rochester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-15

Primary Completion

2023-08-29

Completion

2028-01-01

FDA Drug

Yes

Countries

• United States

Study Locations