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Virus Therapy

Modified Virus Therapy for Cancer

Phase 1
Recruiting
Led By Nora Bennani, 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
Age >= 18 years
Relapsed peripheral T-cell lymphoma (PTCL) of specific histologies with failed standard therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a modified virus that may be able to kill cancer cells, with or without a drug that may stop tumor cell growth.

Who is the study for?
This trial is for adults over 18 with relapsed or refractory multiple myeloma, acute myeloid leukemia, or lymphoma. Participants must have a life expectancy of at least 12 weeks and be able to perform daily activities with minimal assistance (ECOG PS 0-2). They should not have HIV, active hepatitis, certain heart/CNS disorders, uncontrolled infections, or be pregnant/nursing.Check my eligibility
What is being tested?
The trial tests VSV-hIFNbeta-NIS virus therapy alone or combined with cyclophosphamide (a DNA-damaging agent), ipilimumab and nivolumab (immunotherapies) in patients whose cancer has returned or resisted treatment. It aims to find the best dose and assess side effects while trying to kill cancer cells without harming normal ones.See study design
What are the potential side effects?
Potential side effects include immune system reactions due to the virus therapy and immunotherapy agents which may cause flu-like symptoms, fatigue, skin reactions; cyclophosphamide can lead to nausea and hair loss. The severity of these side effects will vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My PTCL has returned after standard treatment failed.
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My blood cancer can be measured by tests.
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My multiple myeloma has returned or didn't respond to treatment with IMID, a proteasome inhibitor, and an alkylating agent.
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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 have B-cell lymphoma (not Burkitt's) or HCN at any stage.
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My brain and spinal cord are free from cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years 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 of grade 3 or higher
Secondary outcome measures
Clinical response
Overall survival
Progression-free survival
Other outcome measures
Biodistribution and kinetics of virus spread
NIS gene expression in tumor samples

Side effects data

From 2012 Phase 2 trial • 124 Patients • NCT01334918
15%
Flushing
13%
Headache
11%
Dyspnoea
9%
Chest discomfort
9%
Dizziness
8%
Nausea
3%
Angina pectoris
1%
Gastritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
SPECT
MDCT

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group D (VSV-IFNbeta-NIS, ruxolitinib, cemiplimab)Experimental Treatment9 Interventions
Patients receive VSV-IFNbeta-NIS IV over 30 minutes on day 1, ipilimumab IV over 30 minutes on day -3 and cemiplimab IV over 30 minutes on day -3 in the absence of disease progression or unacceptable toxicity. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.
Group II: Group C (VSV-IFNbeta-NIS, ruxolitinib, nivolumab)Experimental Treatment9 Interventions
Patients receive VSV-IFNbeta-NIS IV, ipilimumab IV and nivolumab IV while on study. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.
Group III: Group B (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide)Experimental Treatment8 Interventions
Patients receive VSV-IFNbeta-NIS IV and cyclophosphamide IV while on study. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.
Group IV: Group A (VSV-IFNbeta-NIS)Experimental Treatment7 Interventions
Patients receive VSV-IFNbeta-NIS intravenously (IV) while on study. Patients undergo SPECT, CT scan, PET scan throughout the study. Patients may undergo tumor biopsy, bone marrow biopsy and blood sample collection throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Biopsy
2014
Completed Phase 4
~840
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Cyclophosphamide
1995
Completed Phase 3
~3780
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750
Positron Emission Tomography
2008
Completed Phase 2
~2260
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,365 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,227 Total Patients Enrolled
Nora Bennani, M.D.Principal InvestigatorMayo Clinic in Rochester

Media Library

Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03017820 — Phase 1
T-Cell Lymphoma Research Study Groups: Group B (VSV-IFNbeta-NIS, ruxolitinib, cyclophosphamide), Group C (VSV-IFNbeta-NIS, ruxolitinib, nivolumab), Group D (VSV-IFNbeta-NIS, ruxolitinib, cemiplimab), Group A (VSV-IFNbeta-NIS)
T-Cell Lymphoma Clinical Trial 2023: Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter Highlights & Side Effects. Trial Name: NCT03017820 — Phase 1
Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03017820 — Phase 1

Frequently Asked Questions

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

How many individuals are being accepted as participants in this research study?

"Correct. The clinicaltrials.gov website highlights that this experiment, which was initially advertised on April 4th 2017, is currently recruiting participants. 65 individuals need to be enrolled from two distinct research facilities."

Answered by AI

Is this clinical exploration actively seeking participants?

"Confirming the details from clinicaltrials.gov, this study is still open for enrolment. The trial was first made available on April 4th 2017 and its most recent update was on February 3rd 2022."

Answered by AI

Has the Pharmacological Study been given regulatory authorization by the FDA?

"Our team's assessment of Pharmacological Study's safety is a score of 1 since it is currently in Phase 1 and there has only been limited clinical data on efficacy and security."

Answered by AI

For what medical ailments is Pharmacological Study regularly administered?

"Pharmacological Study can be deployed to address clouded lenses, senile cataracts, and abscesses."

Answered by AI

Have past pharmacological studies yielded any noteworthy outcomes?

"The initial Pharmacological Study was conducted in 1997 at the City of Hope Comprehensive Cancer Center, and since then there have been 1785 successful studies. Currently, 912 active trials are taking place across America--particularly in Rochester, Minnesota."

Answered by AI
~11 spots leftby Dec 2024