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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
Women who have gone through a bi-lateral oophorectomy procedure
Recurrent, persistent, or progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after treatment with bilateral oophorectomy and specific chemotherapy regimens
Must not have
Measurable disease outside of the peritoneal cavity as per specified criteria
Resistance to specific chemotherapy agents as per specified criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer can be measured and is outside the belly area.
Select...
My cancer did not respond to certain chemotherapy treatments.
Select...
My ovarian tumor is of a type that tends to grow and spread slowly.
Select...
My cancer has spread and formed large tumors.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
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 study objectives
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
87%
Fever
87%
Platelet count decreased
80%
Nausea
73%
Chills
73%
Leukocyte count decreased
67%
Diarrhea
67%
Cough
60%
Neutrophil count decreased
53%
Vomiting
47%
Creatinine increased
33%
Lymphocyte count decreased
27%
Headache
27%
Upper respiratory infection
27%
Rash desquamating
20%
Hypoxia
13%
Encephalopathy
13%
CD4 lymphocytes decreased
13%
Hypotension
13%
Disseminated intravascular coagulation
7%
Hypothyroidism
7%
Ear, nose and throat examination abnormal
7%
Pain
7%
Dehydration
7%
Hypocalcemia
7%
Thrombosis
7%
Febrile neutropenia
7%
Electrocardiogram QTc interval prolonged
7%
Confusion
7%
Sinus bradycardia
7%
Fatigue
7%
Injection site reaction
7%
Cytokine release syndrome
7%
Infection
7%
Peripheral nerve infection
7%
Anorexia
7%
Insomnia
7%
Hypercalcemia
7%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
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 2 (MV-NIS and Cyclophosphamide) Dose Level 3
Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~70

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,351 Previous Clinical Trials
3,060,891 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,122 Total Patients Enrolled
Evanthia Galanis, M.D.Principal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

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Peritoneal Carcinoma 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
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