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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I've had treatments for endometrial cancer, but my last treatment was over 4 weeks ago.
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My cancer is one of the specified types of epithelial cell cancer.
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I have had vaginal brachytherapy before.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Maximum tolerated dose of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib phosphate)
Secondary outcome measures
Biodistribution and kinetics of virus spread and NIS gene expression in vivo
Number of clinical responses
Time until hematologic nadirs (white blood cells, absolute neutrophil count, platelets)
+2 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

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
Biospecimen Collection
2004
Completed Phase 2
~1920
Ruxolitinib Phosphate
2011
Completed Phase 2
~390
Biopsy
2014
Completed Phase 4
~1090
Positron Emission Tomography
2008
Completed Phase 2
~2260
Computed Tomography
2017
Completed Phase 2
~2790

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,175 Previous Clinical Trials
3,758,127 Total Patients Enrolled
5 Trials studying Endometrial Cancer
4,702 Patients Enrolled for Endometrial Cancer
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,241 Total Patients Enrolled
75 Trials studying Endometrial Cancer
72,425 Patients Enrolled for Endometrial Cancer
Jamie N. Bakkum-Gamez, M.D.Principal InvestigatorMayo Clinic in Rochester
1 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

VSV-hIFNbeta-NIS (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03120624 — Phase 1
Endometrial Cancer Research Study Groups: Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy), Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy)
Endometrial Cancer Clinical Trial 2023: VSV-hIFNbeta-NIS Highlights & Side Effects. Trial Name: NCT03120624 — Phase 1
VSV-hIFNbeta-NIS (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03120624 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there capacity for additional participants in this examination?

"Affirmative. The details provided by clinicaltrials.gov suggest that this medical trial is still accepting participants, having been initially posted on September 15th 2017 and most recently updated on July 14th 2022. 77 individuals from one site are required to complete the study's requirements."

Answered by AI

What is the primary purpose of this medical experiment?

"The main outcome of this trial, observed over a 28-day span, is the incidence of adverse reactions. Other objectives include quantifying viral replication and shedding through reverse transcriptase polymerase chain reaction (using descriptive statistics and scatterplots) as well as assessing biodistribution/kinetics in vivo with single photon emission computed tomography/computed tomatography scans. Additionally, treatment related grade 3+ toxicity will be recorded using NCI CTCAE version 4 standards; simple summaries along with Kaplan-Meier survival estimates plus confidence intervals will be calculated to measure impact based on dose and other dichotomized factors like age via log"

Answered by AI

Has this Pharmacological Study been certified by the FDA?

"As this is a Phase 1 study, the safety rating of Pharmacological Study was assigned as a low score of 1 due to limited evidence in terms of efficacy and risk mitigation."

Answered by AI

What purpose is Pharmacological Study most commonly used for?

"Pharmacological Study is a common remedy for issues related to the thyroid gland, such as clouding of the lenses, senile cataract, and abscesses."

Answered by AI

How many participants are being monitored during this clinical research?

"That is accurate. Clinicaltrials.gov has the most up-to-date information, which reveals that this clinical trial was first posted on September 15th 2017 and last updated on July 14th 2022. Currently, 77 participants are needed from 1 medical facility to join this research study."

Answered by AI
~1 spots leftby Jun 2024