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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreOther 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 moreSide effects data
From 2019 Phase 1 & 2 trial • 48 Patients • NCT00450814100%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured and is outside the belly area.I meet the health and treatment history requirements for safety.My blood, liver, kidney, and heart are functioning within normal ranges.I am eligible for or have chosen DOXIL as part of my treatment plan.You have a disease that can be measured or evaluated based on specific criteria.I am willing to consider surgery for a research port and biopsy if needed.I cannot stop my blood thinner medication for up to 7 days.My cancer did not respond to certain chemotherapy treatments.My ovarian tumor is of a type that tends to grow and spread slowly.I have had both of my ovaries surgically removed.My ovarian, fallopian tube, or peritoneal cancer has returned or worsened after specific treatments.My cancer has spread and formed large tumors.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (DOXIL, GEM, TOPA, TAXOL)
- Group 2: Arm A (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.