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Virus Therapy

Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter for Breast Cancer

Phase 1
Waitlist Available
Led By Scott Okuno
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease
Pathologically confirmed squamous cell carcinoma of the head and neck OR pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2) status and radiographic evidence of distant metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a virus that may kill cancer cells without damaging normal cells in patients with squamous cell carcinoma of the head and neck or breast cancer that has spread to other parts of the body.

Eligible Conditions
  • Breast Cancer
  • HER2 Positive
  • Head and Neck Cancers
  • Progesterone Receptor Positive
  • No change needed.
  • Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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
MTD defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) as assessed by the National Cancer (NCI) CTCAE v. 4.0
Number of toxicity incidents defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment
Secondary outcome measures
Number of responses using Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1
Time to tumor progression
Other outcome measures
Biodistribution of virally infected cells, assessed using SPECT/CT
Cellular immune response
Humoral immune response
+5 more

Side effects data

From 2019 Phase 1 & 2 trial • 48 Patients • NCT00450814
100%
Hemoglobin decreased
100%
Nausea
100%
Leukocyte count decreased
100%
Lymphocyte count decreased
100%
Neutrophil count decreased
100%
Cough
100%
Platelet count decreased
50%
Hypokalemia
50%
Left ventricular failure
50%
Diarrhea
50%
Fever
50%
Upper respiratory infection
50%
Creatinine increased
50%
Hyponatremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
Phase II (Acetaminophen + Benadryl + MV-NIS)
Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
Phase I: Stage 1 (MV-NIS Alone) Dose Level 3

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (MV-NIS)Experimental Treatment2 Interventions
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IT on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
2006
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,183 Previous Clinical Trials
3,758,999 Total Patients Enrolled
83 Trials studying Breast Cancer
14,046 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,620 Previous Clinical Trials
40,927,338 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Scott OkunoPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
81 Total Patients Enrolled

Frequently Asked Questions

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

What medical conditions is Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter a viable treatment for?

"Ocular clouding is often remedied using Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter. This same treatment has been observed to alleviate the symptoms of senile cataract, abscesses, and wound site healing."

Answered by AI

What is the total number of volunteers enrolled in this clinical experiment?

"Unfortunately, this clinical study is not presently enrolling any more patients. The trial was initially posted on April 1st 2013 and revised last February 3rd 2022. If you are still interested in participating in a medical research project, there are currently 5545 trials searching for individuals with the erbb2 gene mutation and 11 studies looking to recruit volunteers who have been infected with an Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned utilization of Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter?

"As this is a Phase 1 trial, with limited evidence of efficacy and safety, our team at Power gave Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter a score of one."

Answered by AI

Is enrollment still possible for this research initiative?

"At the moment, this clinical trial is not open for participant recruitment. Initially posted on April 1st 2013 and last updated February 3rd 2022, it does not currently have any openings. There are presently 5545 trials looking for patients suffering from erbb2 gene related issues that do require volunteers as well as 11 studies searching for participants with Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter needs."

Answered by AI

Are there any precedents for the usage of Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter in a clinical trial?

"Currently, 11 research initiatives related to Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter are ongoing with one study in Phase 3. A majority of these trials is being conducted out of Rochester, Minnesota; however, there are 75 different sites across the world that are running similar studies."

Answered by AI
~1 spots leftby Mar 2025