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Monoclonal Antibodies

Oncolytic Measles Virus Therapy for Ovarian Cancer

Phase 2
Waitlist Available
Led By Evanthia Galanis, 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
Specific criteria related to blood counts, liver and kidney function, and cardiac function
Specific criteria if liposomal doxorubicin hydrochloride (DOXIL) is selected as the investigator's choice chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing if a measles virus that's been changed to only kill cancer cells can work better than chemotherapy at treating ovarian, fallopian, or peritoneal cancer.

Who is the study for?
This trial is for women with certain types of ovarian, fallopian tube, or peritoneal cancer that has come back after treatment. Participants must understand the study and agree to its procedures, including surgery for a port placement and biopsy if needed. They should have specific blood counts and organ functions within range, not be on certain medications or treatments, and cannot have low malignant potential tumors or bulky metastases.Check my eligibility
What is being tested?
The trial compares an altered measles virus therapy (MV-NIS) designed to kill cancer cells without harming normal ones against standard chemotherapy options chosen by the investigator. The effectiveness of these treatments in controlling ovarian-related cancers is being studied.See study design
What are the potential side effects?
Potential side effects may include typical reactions to viral therapies such as fever, fatigue, rash along with those related to chemotherapy like nausea, hair loss, low blood cell counts leading to increased infection risk. Specific side effects depend on which chemotherapy drugs are used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood, liver, kidney, and heart are functioning within normal ranges.
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I am eligible for or have chosen DOXIL as part of my treatment plan.
Select...
I am willing to consider surgery for a research port and biopsy if needed.
Select...
I have had both of my ovaries surgically removed.
Select...
My ovarian, fallopian tube, or peritoneal cancer has returned or worsened after specific treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Incidence of adverse events per Common Terminology Criteria for Adverse Events version 4.0
Objective response rates defined to be a complete response or partial response noted as the objective status on 2 consecutive evaluations at least 4 weeks apart
Overall survival
+2 more
Other outcome measures
Changes in anti-ovarian cancer immune responses in both treatment arms
Gene expression profile predictive of therapeutic response to oncolytic measles virus encoding thyroidal sodium iodide symporter
Humoral and cellular immune responses to oncolytic measles virus encoding thyroidal sodium iodide symporter
+2 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

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (MV-NIS)Experimental Treatment3 Interventions
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (DOXIL, GEM, TOPA, TAXOL)Active Control7 Interventions
Patients receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 1, or gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15, or paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may also receive bevacizumab IV over 30-90 minutes on days 1 and 15 with pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, or paclitaxel. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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
3,176 Previous Clinical Trials
3,757,985 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,580 Total Patients Enrolled
5 Trials studying Endometrioid Adenocarcinoma
1,224 Patients Enrolled for Endometrioid Adenocarcinoma
Evanthia Galanis, M.D.Principal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
69 Total Patients Enrolled

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02364713 — Phase 2
Endometrioid Adenocarcinoma Research Study Groups: Arm A (MV-NIS), Arm B (DOXIL, GEM, TOPA, TAXOL)
Endometrioid Adenocarcinoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT02364713 — Phase 2
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02364713 — Phase 2

Frequently Asked Questions

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

Are there currently any openings for participants in this experiment?

"Affirmative, the information hosted on clinicaltrials.gov confirms that this medical trial is currently recruiting patients. This research was initially posted to the website on March 13th 2015 and has since been revised as of April 8th 2022. Sixty-six participants are needed from three separate sites in order to complete the study's objectives."

Answered by AI

Are there any analogous research projects utilizing Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter?

"The Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter was first researched at Spectrum Health Hospital - Butterworth Campus in 1997. 3965 of these studies have been completed and there are currently 1730 trials being conducted largely out of Scottsdale, Arizona."

Answered by AI

What medical conditions has Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter been found to alleviate?

"Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter is a frequently used treatment for neoplasm metastasis, in addition to hemorrhage, typhus, and Kaposi's sarcoma AIDS-related."

Answered by AI

Is this a pioneering investigation into the subject matter?

"Currently, there are 1730 live trials of the Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter being conducted in 91 countries and 3814 cities. The inception of these studies began with Alfacell's 1997 Phase 3 trial that involved 300 patients. Since then, 3965 investigations have been launched."

Answered by AI

How many subjects are involved in this clinical research?

"Affirmative. Clinicaltrials.gov records reveal that recruitment for this medical research commenced on March 13th 2015 and has continued to the present day, with a recent update made on April 8th 2022. 66 individuals are needed from 3 separate locations."

Answered by AI

What potential harm could be caused by Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter to individuals?

"Based on the safety data gathered thus far, our team at Power assessed Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter with a score of 2. This is because this Phase 2 trial has only collected evidence that supports its safety and not efficacy."

Answered by AI
~16 spots leftby Mar 2027