Modified Virus Therapy +/− Ruxolitinib for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJamie N. Bakkum-Gamez, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with advanced or recurrent endometrial cancer. Participants must have a life expectancy of at least 12 weeks, be able to consent and return for follow-up, and meet specific health criteria like proper kidney function and blood counts. It's not open to those who are pregnant, nursing, have active infections or certain heart conditions, or those who've had recent chemotherapy or other treatments that might interfere.

Inclusion Criteria

Your platelet count is at least 100,000 per microliter within the past 14 days.

Your AST and ALT levels are not more than twice the upper limit of normal.

You are expected to live at least 12 more weeks.

+16 more

Exclusion Criteria

I have not had external beam radiotherapy in the last 4 weeks.

I have brain metastases that are either untreated or causing symptoms.

I have not had immunotherapy in the last 4 weeks.

+18 more

Participant Groups

The study tests VSV-hIFNbeta-NIS alone or combined with ruxolitinib phosphate in stage IV/endometrial cancer patients. The virus targets tumor cells without harming healthy ones and includes a gene helping track the virus in the body. Ruxolitinib may halt tumor growth by blocking enzymes needed for cell growth.

2Treatment groups

Experimental Treatment

Group I: Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy)Experimental Treatment9 Interventions

Patients receive ruxolitinib phosphate PO BID on days -3 to 9. Patients also receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and undergo fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Patients also undergo CT throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study.

Group II: Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy)Experimental Treatment8 Interventions

Patients receive VSV-hIFNbeta-NIS IV over 60-90 minutes on day 1. After 2 days, patients receive technetium Tc-99m sodium pertechnetate IV, and about 30 minutes later, receive fluorine F18 tetrafluoroborate IV and undergo TFB-PET imaging. If previous imaging data are positive, patients receive technetium Tc-99m sodium pertechnetate IV and fluorine F18 tetrafluoroborate IV and undergo another TFB-PET imaging between 7-10 days and on 15 days if needed after VSV-hIFNbeta-NIS infusion. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo CT throughout the study. Patients also undergo mouth rinse, buccal swab and urine on study and blood sample collection throughout the study. Biopsy of accessible NIS image-positive tumors may occur after any imaging. Patients also undergo image-guided biopsy of accessible tumor on day 29.