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

NCT03120624 | Active Not Recruiting Phase 1 Results DMC FDA Drug

• 4 other identifiers: MC1562NCI-2017-00615R01CA20724015-007000
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Participants Who Experienced a Dose-limiting Toxicity (DLT)

  Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. DLT is defined as one of the following events deemed related to the study drug; Grade 2+ allergic reaction or cytokine release syndrome, or any grade 3+ with the exception of lymphopenia or other related events (e.g., anemia, white blood cell count decreased), which will not be considered a dose limiting toxicity. Grade ≥3 flu-like symptoms, fever, nausea, vomiting, dehydration, diarrhea, headache, myalgia, fatigue, ALT increased, or AST increased, will also not be considered as a dose limiting toxicity as they are anticipated toxicities of treatment.

  28 days

Secondary Outcomes (6)

• Incidence of Adverse Events

  Up to 1 year

• Number of Clinical Responses

  Up to 1 year

• Viral Replication and Shedding in Blood, Throat Washings, Urine, and Buccal Swabs Assessed Via Quantitative Reverse Transcriptase Polymerase Chain Reaction

  Up to 1 year

• Count of Patients With Positive Virus Spread.

  10 days

• Time Until Treatment Related Grade 3+ Toxicity

  Up to 1 year

Study Arms (2)

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

EXPERIMENTAL

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.

Procedure: Biopsy; Procedure: Computed Tomography; Other: Fluorine F 18 Tetrafluoroborate; Other: Pharmacological Study; Procedure: Positron Emission Tomography; Biological: Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter; Drug: Technetium Tc-99m Sodium Pertechnetate; Procedure: Biospecimen Collection

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

EXPERIMENTAL

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.

Procedure: Biopsy; Procedure: Computed Tomography; Other: Fluorine F 18 Tetrafluoroborate; Other: Pharmacological Study; Procedure: Positron Emission Tomography; Biological: Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter; Drug: Ruxolitinib Phosphate; Drug: Technetium Tc-99m Sodium Pertechnetate; Procedure: Biospecimen Collection

Interventions

Biopsy PROCEDURE

Undergo image-guided biopsy

Also known as: Biopsy Type, BIOPSY_TYPE, Bx

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

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

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

Fluorine F 18 Tetrafluoroborate OTHER

Given IV

Also known as: 18F-Tetrafluoroborate, 18F-TFB

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

Pharmacological Study OTHER

Correlative studies

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

Positron Emission Tomography PROCEDURE

Undergo TFB-PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

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

Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter BIOLOGICAL

Given IV

Also known as: 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

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

Ruxolitinib Phosphate DRUG

Given PO

Also known as: 1092939-17-7, INCB-18424 Phosphate, Jakafi, Jakavi

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

Technetium Tc-99m Sodium Pertechnetate DRUG

Given IV

Also known as: Pertscan-99m, Sodium Pertechnetate (Na99mtco4), Tc 99m Generator, Ultra-Technekow FM

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

Biospecimen Collection PROCEDURE

Undergo mouth rinse, buccal swab, urine, and blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Availability of and patient acceptance of curative therapy
• Active infection requiring treatment, 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Biopsy; Magnetic Resonance Spectroscopy; sodium-iodide symporter; ruxolitinib; Sodium Pertechnetate Tc 99m; Radionuclide Generators; Specimen Handling

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Technetium Compounds; Inorganic Chemicals; Radiation Equipment and Supplies; Equipment and Supplies

Results Point of Contact

• Title: Jamie N Bakkum-Gamez MD
• Organization: Mayo Clinic

bakkum.jamie@mayo.edu

507-284-2511

Study Officials

• Jamie N. Bakkum-Gamez, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 19, 2017
• Study Start: September 15, 2017
• Primary Completion: August 29, 2023
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 4, 2026
• Results First Posted: October 29, 2024

Record last verified: 2026-01

Locations

US (1)