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Virus Therapy
Vaccine Therapy for Peripheral Nerve Sheath Tumor
Phase 1
Recruiting
Led By Dusica Babovic-Vuksanovic
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
Pathologically confirmed MPNST, with or without underlying diagnosis of neurofibromatosis type 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new cancer vaccine therapy to see what side effects it has and what the best dose is. The therapy is for people with a type of cancerous tumor that can't be removed by surgery or has come back after a period of improvement.
Who is the study for?
This trial is for patients with a type of cancer called malignant peripheral nerve sheath tumor that has returned or can't be removed by surgery. Participants must have measurable disease, not be pregnant or nursing, willing to use contraception, and able to complete questionnaires. They should not have severe diseases that could interfere with the study, active infections, recent treatments with chemotherapy or immunotherapy, blood product support needs, CNS metastases or seizure disorders.Check my eligibility
What is being tested?
The trial is testing a vaccine therapy using a gene-modified virus aimed at killing tumor cells in patients whose tumors express the NF1 gene without harming normal cells. It also seeks to stimulate an immune response against these cancer cells. The best dose and side effects are being studied.See study design
What are the potential side effects?
Potential side effects may include reactions specific to the vaccine such as local skin reactions at injection sites, flu-like symptoms including fever and fatigue, allergic responses due to components of the vaccine like measles virus proteins or iodine used in imaging studies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have a confirmed diagnosis of malignant peripheral nerve sheath tumor (MPNST).
Select...
I can take care of myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best response using the World Health Organization response criteria
Incidence of adverse events according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Maximum tolerated dose defined as the highest safely tolerated dose level where at most 1 out of 6 patients experience dose-limiting toxicity (DLT) with the next higher dose having at least 2 patients out of a maximum of 6 patients experience DLT
Secondary outcome measures
Absolute percentage change in quality of life measured using the Brief Pain Inventory (short form) and Brief Fatigue Inventory
Change in biodistribution of virally infected cells at various time points after infection with MV-NIS using single photon emission computed tomography/computed tomography
Growth-rate between treated and untreated lesions
+9 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (MV-NIS)Experimental Treatment10 Interventions
Patients receive MV-NIS intratumorally on day 1. Patients also undergo SPECT/CT at baseline and at 3 and 8 days after MV-NIS. Patients may also undergo SPECT/CT at 15 and 28 days, and at 6 weeks based on whether there is uptake on prior imaging studies. Patients also undergo MRI, ultrasound imaging, blood sample collection and tissue biopsy throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Ultrasound Imaging
2018
Completed Phase 4
~730
Biopsy
2014
Completed Phase 4
~1090
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
2006
Completed Phase 2
~60
Biospecimen Collection
2004
Completed Phase 2
~1700
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,824 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,212 Previous Clinical Trials
3,767,008 Total Patients Enrolled
Dusica Babovic-VuksanovicPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
26 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy in the last 3 weeks.I am currently breastfeeding.I am allergic to lidocaine, fentanyl, midazolam, or propofol.I have brain metastases or a seizure disorder.I am HIV-positive or have a history of immunodeficiency.I have a history of chronic hepatitis B or C.I am 18 years old or older.I have not had radiation therapy in the last 3 weeks.I have recovered from my last chemotherapy, except for hair loss and nerve issues.I am not currently receiving any experimental treatments.I have had an organ transplant.I am not willing to use birth control during and for 8 weeks after treatment.I am on blood thinners for treatment.I have not had an active infection in the last 5 days.I have had tuberculosis or a positive TB skin test in the past.I am not taking any corticosteroids except for creams or inhalers.I have a confirmed diagnosis of malignant peripheral nerve sheath tumor (MPNST).I can take care of myself but may not be able to do heavy physical work.I need blood transfusions or products to manage my condition.I have multiple cancer sites, but only one large enough lesion will be treated.I have not had immunotherapy in the last 4 weeks.I haven't had biologic therapy in the last 4 weeks.My MPNST cannot be cured with standard treatments, includes inoperable tumors, or has spread.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (MV-NIS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has research been conducted on Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter?
"At this time, 11 trials of Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter are active with 1 in its final phase. These studies are primarily conducted out of Rochester, Minnesota but span 75 different locations around the world."
Answered by AI
What is the enrollment figure for this clinical trial?
"Affirmative. According to the clinicaltrials.gov website, this trial is still open for enrolment with a total of 30 participants needed from one site. It was first posted on December 8th 2017 and recently updated on July 6th 2022."
Answered by AI
What medical indications are usually treated with Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter?
"OMV-TS is regularly employed to treat ocular clouding, senile cataract, abscesses, and wound site."
Answered by AI
Are there any vacancies left in this medical study?
"Yes, the information posted on clinicaltrials.gov demonstrates that this medical research is still in need of participants. The study was originally launched on December 8th 2017 and has since been updated most recently on July 6th 2022."
Answered by AI
What unfavorable outcomes have been linked with Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter?
"Due to the preliminary data available on Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter, this medication received a score of 1 in terms of safety. As it is currently at Phase 1 in clinical trials, there are few studies that have evaluated its efficacy and safety."
Answered by AI
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