Your session is about to expire
← Back to Search
Virus Therapy
Measles Virus-Infected Stem Cells for Ovarian Cancer
Phase 1 & 2
Recruiting
Led By Evanthia Galanis
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recurrent or progressive ovarian cancer, primary peritoneal cancer or fallopian tube cancer after prior treatment with platinum and taxanes
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses a measles virus to carry a cancer-killing substance directly to ovarian, primary peritoneal, and fallopian tube cancer cells.
Who is the study for?
This trial is for patients with recurrent ovarian, primary peritoneal or fallopian tube cancer who have previously been treated with platinum and taxanes. Participants must have adequate organ function, an ECOG performance status of 0-2, a life expectancy of at least 12 weeks, and no history of certain other conditions like severe allergies to measles vaccine or immunodeficiency.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of MV-NIS infected mesenchymal stem cells in treating recurrent cancers mentioned above. It's looking for the best dose that can carry tumor-killing substances directly to cancer cells without causing too many side effects.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to stem cell transplantation such as immune response complications, infection risks due to weakened immunity from the virus used in treatment, allergic reactions especially if there's a known allergy to measles vaccine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My ovarian, peritoneal, or fallopian tube cancer has returned or worsened after treatment with platinum and taxanes.
Select...
I can take care of myself but may not be able to do heavy physical work.
Select...
I have had both of my ovaries surgically removed.
Select...
My heart's pumping ability is normal.
Select...
My cancer is one of the specified types of epithelial cell cancer.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) (Phase I)
Number and severity of adverse events (Phase I)
Overall toxicity incidence (Phase I)
+2 moreSecondary outcome measures
Maximum grade for each type of toxicity (Phase II)
Overall survival (Phase II)
Progression free survival (Phase II)
+2 moreOther outcome measures
Antitumor immune response (Phase II)
Cellular immune response to the injected virus (Phase II)
Humoral immune response to the injected virus (Phase II)
+5 moreSide effects data
From 2019 Phase 1 & 2 trial • 48 Patients • NCT0045081475%
Hemoglobin decreased
75%
Leukocyte count decreased
50%
Creatinine increased
25%
Anorexia
25%
Chills
25%
Rash desquamating
25%
Pneumonitis
25%
Diarrhea
25%
Nausea
25%
Fever
25%
Neutrophil count decreased
25%
Platelet count decreased
25%
Hypercalcemia
25%
Bone pain
25%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
Phase II (Acetaminophen + Benadryl + MV-NIS)
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
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
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (MV-NIS infected mesenchymal stem cells)Experimental Treatment3 Interventions
Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IP over 30 minutes on day 1 of cycle 1 and MV-NIS infected MSC (if MSC are not available, MV-NIS may be given alone) IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles 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
Mesenchymal Stem Cell Transplantation
2016
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,464 Total Patients Enrolled
23 Trials studying Fallopian Tube Carcinoma
6,798 Patients Enrolled for Fallopian Tube Carcinoma
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,083 Total Patients Enrolled
Evanthia GalanisPrincipal InvestigatorMayo Clinic
8 Previous Clinical Trials
533 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had an active infection in the last 5 days.Your white blood cell count is at least 1500 cells per microliter.I need blood transfusions or products to manage my condition.I am not currently receiving any experimental treatments.My ovarian, peritoneal, or fallopian tube cancer has returned or worsened after treatment with platinum and taxanes.My ovarian tumor is of a type that tends to grow and spread slowly.My cancer has returned more than 6 months after finishing my first chemotherapy.You are allergic to the measles vaccine or had a severe reaction to it before.Your AST blood test result is not more than twice the upper limit of normal. This test must have been done within 7 days before you join the study.Your hemoglobin level is at least 9.0 grams per deciliter within the past 7 days before joining the study.You are expected to live for at least 12 more weeks.My cancer can be measured by scans or tests, or I agree to a laparoscopy if needed.I have not had immunotherapy in the last 4 weeks.I have heart or lung conditions that may affect my treatment safety.I have had an organ transplant.I have a history of chronic hepatitis B or C.My cancer is larger than 8 cm, affects my liver, or has spread beyond my abdomen.I can take care of myself but may not be able to do heavy physical work.I have had both of my ovaries surgically removed.You need to have a biopsy to confirm the type of cancer you have.I have received radiation therapy to my abdomen or pelvis.I am not taking any oral or systemic corticosteroids, except for creams or inhalers.Your kidney function is within normal limits, based on a test done within the last week.I have not had major abdominal surgery within the last 3 weeks.You are allergic to iodine, but not allergic to intravenous contrast materials.Your platelet count is at least 100,000 per microliter of blood, measured within the last 7 days before enrolling in the study.I have had tuberculosis or a positive TB skin test.You have been in close contact with a household member who is less than 15 months old or has a weakened immune system.I haven't had cancer, except for certain skin, cervical, or breast cancers, in the last 5 years.You have any other health problems that might make the treatment unsafe, as decided by the main doctor in charge of the study.I have not received any viral or gene therapy before signing up.You have a certain level of white blood cells called CD4 count.My heart's pumping ability is normal.I have severe heart issues, including arrhythmias or symptomatic coronary artery disease.I have brain metastases or a seizure disorder.Your total bilirubin level must be within the normal range when tested within 7 days before joining the study.My cancer is one of the specified types of epithelial cell cancer.I have not had biologic therapy in the last 4 weeks.I am HIV positive or have a history of immunodeficiency.I haven't had chemotherapy in the last 3 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (MV-NIS infected mesenchymal stem cells)
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.
Are enrollment procedures still available for this investigation?
"According to clinicaltrials.gov, this research study is actively recruiting participants at present. The investigation was originally posted on March 31st 2014 and was last updated on the 11th of March 2022."
Answered by AI
What health conditions is Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter typically employed in treating?
"Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter is generally used to treat clouding of the lenses, but has also been successful in treating senile cataract, abscesses, and wound site."
Answered by AI
Have there been any other investigations conducted involving Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter?
"At present, there are 11 research projects in progress for Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter. Of these studies, one is currently in its third phase of clinical trials. Most of the trials concerning this treatment are situated around Rochester, Minnesota however 75 other sites globally have begun to test it too."
Answered by AI
How many participants are included in the cohort of this research?
"Affirmative. Per the records on clinicaltrials.gov, this experiment is seeking participants as of now. It was initially posted in March 31st 2014 and recently updated on March 11th 2022; The study requires 57 individuals from a single site."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger