Measles Virus-Infected Stem Cells for Ovarian Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mayo Clinic

Must not be taking: Corticosteroids

Disqualifiers: Active infection, Cardiac disease, CNS metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 24 weeks

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I/II trial studies the side effects and best dose of oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) infected mesenchymal stem cells and to see how well it works in treating patients with ovarian, primary peritoneal or fallopian tube cancer that has come back. Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian, primary peritoneal and fallopian tube cancer cells.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those on certain treatments like chemotherapy, immunotherapy, or biologic therapy within a few weeks before joining. It's best to discuss your specific medications with the trial team.

Is the treatment using measles virus-infected stem cells generally safe for humans?

The treatment using measles virus-infected stem cells has been evaluated in clinical settings, and in one study involving patients with drug-resistant ovarian cancer, it was well tolerated with no dose-limiting toxicity observed. This suggests that the treatment is generally safe in humans, at least in the context of the studies conducted. ^{1 2 3 4 5}

How is the treatment MV-NIS Infected Mesenchymal Stem Cells unique for ovarian cancer?

This treatment uses mesenchymal stem cells (special cells that can develop into different types of cells) to carry a modified measles virus directly to ovarian cancer cells, protecting the virus from being neutralized by the body's immune system. This approach is different because it combines the virus's ability to kill cancer cells with the stem cells' ability to target tumors, potentially making it more effective than using the virus alone. ^{3 4 5 6 7}

What data supports the effectiveness of this treatment for ovarian cancer?

Research shows that mesenchymal stem cells (MSCs) can protect the measles virus from being neutralized by the immune system, allowing it to effectively target and destroy ovarian cancer cells. Additionally, a study found that a modified measles virus used in patients with drug-resistant ovarian cancer was well tolerated and associated with promising survival rates, suggesting the potential effectiveness of this treatment. ^{1 3 4 5 8}

Who Is on the Research Team?

Evanthia Galanis

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your white blood cell count is at least 1500 cells per microliter.

My ovarian, peritoneal, or fallopian tube cancer has returned or worsened after treatment with platinum and taxanes.

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.

Exclusion Criteria

I have not had an active infection in the last 5 days.

I need blood transfusions or products to manage my condition.

I am not currently receiving any experimental treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive oncolytic measles virus encoding thyroidal sodium iodide symporter intraperitoneally over 30 minutes on day 1 of cycle 1 and MV-NIS infected mesenchymal stem cells IP over 30 minutes of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles.

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 6 months for up to 5 years.

5 years

10 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mesenchymal Stem Cell Transplantation
• MV-NIS Infected Mesenchymal Stem Cells

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (MV-NIS infected mesenchymal stem cells) Experimental Treatment 10 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. Additionally, patients undergo ECHO or MUGA prior to registration and blood sample collection, chest X-ray, SPECT/CT, CT or MRI throughout the study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Optimizing patient derived mesenchymal stem cells as virus carriers for a phase I clinical trial in ovarian cancer. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Systemically delivered measles virus-infected mesenchymal stem cells can evade host immunity to inhibit liver cancer growth. [2021]

3. Greece pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell carriers enhance anti-tumor efficacy of oncolytic virotherapy. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Mesenchymal stem cell carriers protect oncolytic measles viruses from antibody neutralization in an orthotopic ovarian cancer therapy model. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Oncolytic measles virus expressing the sodium iodide symporter to treat drug-resistant ovarian cancer. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Measles Edmonston vaccine strain derivatives have potent oncolytic activity against osteosarcoma. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Oncolytic activities of approved mumps and measles vaccines for therapy of ovarian cancer. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Intraperitoneal therapy of ovarian cancer using an engineered measles virus. [2021]