search
Back to results

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

Primary Purpose

Metastatic Endometrial Carcinoma, Recurrent Endometrial Adenocarcinoma, Recurrent Endometrial Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biopsy
Computed Tomography
Fluorine F 18 Tetrafluoroborate
Laboratory Biomarker Analysis
Pharmacological Study
Planar Imaging
Positron Emission Tomography
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
Ruxolitinib
Ruxolitinib Phosphate
Single Photon Emission Computed Tomography
Technetium Tc-99m Sodium Pertechnetate
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Endometrial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

    • NOTE: histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, adenocarcinoma not otherwise specified (NOS)
    • NOTE: measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
  • Group A only: Largest tumor diameter =< 5 cm

    • NOTE: Group B patients have no maximum tumor size
  • Absolute neutrophil count (ANC) >= 1500/uL (obtained =< 14 days prior to registration)
  • Platelet count (PLT) >= 100,000/uL (obtained =< 14 days prior to registration)
  • Hemoglobin >= 10 g/dL (obtained =< 14 days prior to registration)
  • Creatinine =< 2.0 mg/dL (obtained =< 14 days prior to registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x upper limit of normal (ULN) (obtained =< 14 days prior to registration)

    • NOTE: if baseline liver disease, Child Pugh score not exceeding class A
  • Total bilirubin =< 1.5 x ULN (obtained =< 14 days prior to registration)
  • International normalized ratio (INR)/prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.4 x ULN (obtained =< 14 days prior to registration) unless on therapeutic warfarin then INR/PT =< 3.5
  • Ability to provide written informed consent
  • Willingness to return to Mayo Clinic in Rochester, Minnesota for follow-up
  • Life expectancy >= 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
  • Willingness to provide mandatory biological specimens for research purposes
  • Prior therapy:

    • Any number of prior chemotherapy regimens and/or targeted therapies and/or prior external beam radiation therapy and/or prior hormonal therapy for endometrial cancer are allowed provided the last treatment was > 4 weeks prior to registration
    • Vaginal brachytherapy may have been administered at any time prior to registration

Exclusion Criteria:

  • Availability of and patient acceptance of curative therapy
  • Active infection, including any active viral infection, =< 5 days prior to registration
  • Active or latent tuberculosis or hepatitis
  • Known untreated or symptomatic brain metastases
  • Any of the following prior therapies:

    • Chemotherapy < 4 weeks prior to registration
    • Targeted biologic therapy < 4 weeks prior to registration
    • Immunotherapy < 4 weeks prior to registration
    • Any viral or gene therapy prior to registration
    • External beam radiotherapy < 4 weeks prior to registration

      • NOTE: Vaginal brachytherapy may be performed at any time prior to registration
  • New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or uncontrolled current cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT])
  • Active central nervous system (CNS) disorder or seizure disorder or known CNS disease or neurologic symptomatology
  • Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression
  • History of hepatitis B or C or chronic hepatitis
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation)
  • Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids
  • Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

    • Pregnant persons or persons of reproductive ability who are unwilling to use effective contraception
    • Nursing persons
  • Any other pathology or condition that the principal investigator deems to negatively impact treatment safety
  • Any immunotherapy-related adverse events Common Terminology Criteria for Adverse Events (CTCAE) > grade 1 at the time of registration
  • Receipt of a live virus vaccine =< 2 months prior to registration

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A (VSV-hIFNbeta-NIS, SPECT/CT, TFB-PET, biopsy)

Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy)

Arm Description

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, undergo whole body planar imaging and SPECT/CT imaging or 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 another planar and SPECT/CT imaging or 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 image-guided biopsy of accessible tumor on day 29.

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, undergo whole body planar imaging and SPECT/CT imaging or 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 another planar and SPECT/CT imaging or 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 image-guided biopsy of accessible tumor on day 29.

Outcomes

Primary Outcome Measures

Maximum tolerated dose of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib phosphate)
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Defined as the highest safely-tolerated dose level where at most one patient out of six experiences dose limiting toxicities (DLT) with the next higher dose level having at least 2 of 6 patients who have experienced DLT.
Incidence of adverse events
Graded according to the NCI CTCAE version 4. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals.

Secondary Outcome Measures

Number of clinical responses
Defined as complete response, partial response, or stable disease assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be summarized by simple descriptive summary statistics across all patients in each group as well as by dose level and primary type of cancer (EC).
Viral replication and shedding in blood, throat washings, urine, and buccal swabs assessed via quantitative reverse transcriptase polymerase chain reaction
Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations with other outcome measures will be carried out by standard parametric and non-parametric tests (e.g. Pearson's and Spearman's rho).
Biodistribution and kinetics of virus spread and NIS gene expression in vivo
Assessed via single-photon emission computed tomography/computed tomography. Will be correlated with tumor distribution.
Time until treatment related grade 3+ toxicity
Graded according to the NCI CTCAE version 4. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using logrank testing involving one covariate at a time.
Time until hematologic nadirs (white blood cells, absolute neutrophil count, platelets)
Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using logrank testing involving one covariate at a time.

Full Information

First Posted
April 14, 2017
Last Updated
August 29, 2023
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03120624
Brief Title
VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Patients With Stage IV or Recurrent Endometrial Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the optimal dose schedule, safety and tolerability as measured by the incidence of significant toxicity of VSV-hIFNbeta-NIS in immunocompetent patients with metastatic and/or recurrent endometrial cancer (EC). SECONDARY OBJECTIVES: I. To determine the toxicity profile of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib phosphate [ruxolitinib]). II. To determine the time course of viral gene expression and virus elimination, and the biodistribution of virally infected cells at various times points after infection with VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib) using Tc-99m pertechnetate planar and single photon emission computed tomography (SPECT)/computed tomography (CT) or fluorine F18 tetrafluoroborate (TFB)-positron emission tomography (PET) imaging. III. To assess virus replication, viremia; viral shedding in urine and respiratory secretions; and virus persistence after intravenous (IV) administration of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib). IV. To monitor humoral responses to the injected virus. V. To estimate the tumor response rate and overall survival. CORRELATIVE OBJECTIVES: I. To determine the pharmacokinetic (PK) profile of VSV-IFNbeta-NIS in patients with EC by measurement of VSV-IFNbeta-NIS in blood by reverse transcriptase polymerase chain reaction (RT-PCR). II. To characterize the pharmacodynamics (PD) of VSV-IFNbeta-NIS by way of measuring serum interferon-beta and also VSV-RT-PCR of VSV-IFNbeta-NIS listed above. III. Assess CD8+ T cell (both general and VSV-IFNbeta-NIS specific) and natural killer (NK) cell responses. IV. Gene expression analysis pre- and post-virotherapy. V. Evaluate transcription of interferon mediated genes (protein kinase R, the death receptor-TRAIL, 2'-5' oligoadenylate/RNAse L proteins, heat shock proteins [Hsp 60/70/90], major histocompatibility class antigens and IRF-7). VI. Assess presence of VSV in tumor and normal tissues subsequent to administration of IV VSV-IFNbeta-NIS. OUTLINE: This is a dose-escalation study of VSV-hIFNbeta-NIS. Patients are randomized to 1 of 2 arms. ARM A: 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, undergo whole body planar imaging and SPECT/CT imaging or 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 another planar and SPECT/CT imaging or 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 image-guided biopsy of accessible tumor on day 29. ARM B: Patients receive ruxolitinib phosphate orally (PO) twice daily (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, undergo whole body planar imaging and SPECT/CT imaging or 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 another planar and SPECT/CT imaging or 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 image-guided biopsy of accessible tumor on day 29. After completion of study treatment, patients are followed up at day 29, every 3 months until disease progression and then every 6 months for up to 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Stage IVA Uterine Corpus Cancer AJCC v7, Stage IVB Uterine Corpus Cancer AJCC v7

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (VSV-hIFNbeta-NIS, SPECT/CT, TFB-PET, biopsy)
Arm Type
Experimental
Arm Description
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, undergo whole body planar imaging and SPECT/CT imaging or 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 another planar and SPECT/CT imaging or 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 image-guided biopsy of accessible tumor on day 29.
Arm Title
Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy)
Arm Type
Experimental
Arm Description
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, undergo whole body planar imaging and SPECT/CT imaging or 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 another planar and SPECT/CT imaging or 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 image-guided biopsy of accessible tumor on day 29.
Intervention Type
Procedure
Intervention Name(s)
Biopsy
Other Intervention Name(s)
Biopsy Type, BIOPSY_TYPE, Bx
Intervention Description
Undergo image-guided biopsy
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo SPECT/CT
Intervention Type
Other
Intervention Name(s)
Fluorine F 18 Tetrafluoroborate
Other Intervention Name(s)
18F-Tetrafluoroborate, 18F-TFB
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
Pharmacological Study
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
Planar Imaging
Intervention Description
Undergo whole body planar imaging
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo TFB-PET
Intervention Type
Biological
Intervention Name(s)
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter
Other Intervention Name(s)
Oncolytic VSV-hIFNbeta-NIS, Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter, Voyager-V1, VSV-expressing hIFNb and NIS, VSV-hIFNb-NIS, VSV-hIFNbeta-NIS, VV1
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
INCB-18424, INCB18424, Jakafi, Oral JAK Inhibitor INCB18424
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib Phosphate
Other Intervention Name(s)
INCB-18424 Phosphate, Jakafi
Intervention Description
Given PO
Intervention Type
Procedure
Intervention Name(s)
Single Photon Emission Computed Tomography
Other Intervention Name(s)
Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT, SPECT imaging, SPECT SCAN, SPET, tomography, emission computed, single photon, Tomography, Emission-Computed, Single-Photon
Intervention Description
Undergo SPECT/CT
Intervention Type
Drug
Intervention Name(s)
Technetium Tc-99m Sodium Pertechnetate
Other Intervention Name(s)
Pertscan-99m, Sodium Pertechnetate (Na99mtco4), Tc 99m Generator, Ultra-Technekow FM
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Maximum tolerated dose of VSV-hIFNbeta-NIS (alone and in combination with ruxolitinib phosphate)
Description
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Defined as the highest safely-tolerated dose level where at most one patient out of six experiences dose limiting toxicities (DLT) with the next higher dose level having at least 2 of 6 patients who have experienced DLT.
Time Frame
Up to 28 days
Title
Incidence of adverse events
Description
Graded according to the NCI CTCAE version 4. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Number of clinical responses
Description
Defined as complete response, partial response, or stable disease assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be summarized by simple descriptive summary statistics across all patients in each group as well as by dose level and primary type of cancer (EC).
Time Frame
Up to 1 year
Title
Viral replication and shedding in blood, throat washings, urine, and buccal swabs assessed via quantitative reverse transcriptase polymerase chain reaction
Description
Descriptive statistics and scatterplots will form the basis of presentation of these variables. Correlations with other outcome measures will be carried out by standard parametric and non-parametric tests (e.g. Pearson's and Spearman's rho).
Time Frame
Up to 1 year
Title
Biodistribution and kinetics of virus spread and NIS gene expression in vivo
Description
Assessed via single-photon emission computed tomography/computed tomography. Will be correlated with tumor distribution.
Time Frame
Up to day 10
Title
Time until treatment related grade 3+ toxicity
Description
Graded according to the NCI CTCAE version 4. Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using logrank testing involving one covariate at a time.
Time Frame
Up to 1 year
Title
Time until hematologic nadirs (white blood cells, absolute neutrophil count, platelets)
Description
Simple summary statistics will be supplemented with Kaplan-Meier survival estimates and related confidence intervals. The effect of dose and ancillary dichotomized covariates such as age will be explored using logrank testing involving one covariate at a time.
Time Frame
Up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma NOTE: histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, adenocarcinoma not otherwise specified (NOS) NOTE: measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) Group A only: Largest tumor diameter =< 5 cm NOTE: Group B patients have no maximum tumor size Absolute neutrophil count (ANC) >= 1500/uL (obtained =< 14 days prior to registration) Platelet count (PLT) >= 100,000/uL (obtained =< 14 days prior to registration) Hemoglobin >= 10 g/dL (obtained =< 14 days prior to registration) Creatinine =< 2.0 mg/dL (obtained =< 14 days prior to registration) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x upper limit of normal (ULN) (obtained =< 14 days prior to registration) NOTE: if baseline liver disease, Child Pugh score not exceeding class A Total bilirubin =< 1.5 x ULN (obtained =< 14 days prior to registration) International normalized ratio (INR)/prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.4 x ULN (obtained =< 14 days prior to registration) unless on therapeutic warfarin then INR/PT =< 3.5 Ability to provide written informed consent Willingness to return to Mayo Clinic in Rochester, Minnesota for follow-up Life expectancy >= 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 Willingness to provide mandatory biological specimens for research purposes Prior therapy: Any number of prior chemotherapy regimens and/or targeted therapies and/or prior external beam radiation therapy and/or prior hormonal therapy for endometrial cancer are allowed provided the last treatment was > 4 weeks prior to registration Vaginal brachytherapy may have been administered at any time prior to registration Exclusion Criteria: Availability of and patient acceptance of curative therapy Active infection, including any active viral infection, =< 5 days prior to registration Active or latent tuberculosis or hepatitis Known untreated or symptomatic brain metastases Any of the following prior therapies: Chemotherapy < 4 weeks prior to registration Targeted biologic therapy < 4 weeks prior to registration Immunotherapy < 4 weeks prior to registration Any viral or gene therapy prior to registration External beam radiotherapy < 4 weeks prior to registration NOTE: Vaginal brachytherapy may be performed at any time prior to registration New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or uncontrolled current cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia [SVT]) Active central nervous system (CNS) disorder or seizure disorder or known CNS disease or neurologic symptomatology Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression History of hepatitis B or C or chronic hepatitis Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation) Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids Exposure to household contacts =< 15 months old or household contact with known immunodeficiency Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: Pregnant persons or persons of reproductive ability who are unwilling to use effective contraception Nursing persons Any other pathology or condition that the principal investigator deems to negatively impact treatment safety Any immunotherapy-related adverse events Common Terminology Criteria for Adverse Events (CTCAE) > grade 1 at the time of registration Receipt of a live virus vaccine =< 2 months prior to registration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie N Bakkum-Gamez
Organizational Affiliation
Mayo Clinic in Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Referral Office
Phone
855-776-0015
Email
mayocliniccancerstudies@mayo.edu
First Name & Middle Initial & Last Name & Degree
Jamie N. Bakkum-Gamez, M.D.

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs