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Virus Therapy

Modified Virus Therapy +/− Ruxolitinib for Endometrial Cancer

Phase 1

Waitlist Available

Led By Jamie N. Bakkum-Gamez, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Largest tumor diameter =< 5 cm for Group A patients

Measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma

Must not have

External beam radiotherapy < 4 weeks prior to registration

Known untreated or symptomatic brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a modified virus that only infects cancer cells, with or without a drug that inhibits cancer cell growth. The goal is to find the best dose with the least side effects.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical reactions from viral therapy such as flu-like symptoms (fever, fatigue), injection site reactions, allergic responses, changes in blood pressure or heart rate. Ruxolitinib can cause dizziness, headache, weight gain due to fluid retention among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My largest tumor is 5 cm or smaller.

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My endometrial cancer is at an advanced stage or has come back.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer is one of the specified types of epithelial cell cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I do not have active or latent tuberculosis or hepatitis.

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I have not received any viral or gene therapy before signing up.

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I have severe heart issues or uncontrolled heart rhythm problems.

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I have an active brain disorder or seizures.

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I am HIV positive or have a weakened immune system.

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I am not currently on any experimental treatments.

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I have not received a live virus vaccine in the last 2 months.

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I haven't had targeted therapy in the last 4 weeks.

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I have had hepatitis B, C, or chronic hepatitis.

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I have no severe side effects from immunotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participants Who Experienced a Dose-limiting Toxicity (DLT)

Secondary study objectives

Count of Patients With Positive Virus Spread.

Incidence of Adverse Events

Number of Clinical Responses

+3 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

33%

Infusion Related Reaction

33%

Alanine aminotransferase increased

33%

Aspartate aminotransferase increased

33%

Neutrophil count decreased

17%

Sinusitis

17%

Tumor Lysis Syndrome

17%

Interoperative Hemorrhage

17%

Platelet count decreased

17%

Febrile neutropenia

17%

Infusion related reaction

17%

Upper respiratory infection

17%

Otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Phase 2 and MTD (800 mg Entospletinib Daily)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 3

~2020