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Virus Therapy

Measles Virus-Infected Stem Cells for Ovarian Cancer

Phase 1 & 2

Waitlist Available

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

Must not have

Requiring blood product support

Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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

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I can take care of myself but may not be able to do heavy physical work.

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I have had both of my ovaries surgically removed.

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My heart's pumping ability is normal.

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My cancer is one of the specified types of epithelial cell cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need blood transfusions or products to manage my condition.

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I am not currently receiving any experimental treatments.

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My ovarian tumor is of a type that tends to grow and spread slowly.

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I have not had immunotherapy in the last 4 weeks.

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I have had an organ transplant.

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I have a history of chronic hepatitis B or C.

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I have received radiation therapy to my abdomen or pelvis.

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I have had tuberculosis or a positive TB skin test.

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I have not received any viral or gene therapy before signing up.

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I have severe heart issues, including arrhythmias or symptomatic coronary artery disease.

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I have brain metastases or a seizure disorder.

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I have not had biologic therapy in the last 4 weeks.

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I am HIV positive or have a history of immunodeficiency.

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I haven't had chemotherapy in the last 3 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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.

Primary study objectives

Maximum tolerated dose (MTD) (Phase I)

Number and severity of adverse events (Phase I)

Overall toxicity incidence (Phase I)

+2 more

Secondary study objectives

Overall survival (Phase II)

Progression free survival (Phase II)

Rate of progression free survival (Phase II)

+1 more

Other study objectives

Antitumor immune response (Phase II)

Cellular immune response to the injected virus (Phase II)

Humoral immune response to the injected virus (Phase II)

+5 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

Hypothyroidism

Ear, nose and throat examination abnormal

Pain

Dehydration

Hypocalcemia

Thrombosis

Febrile neutropenia

Electrocardiogram QTc interval prolonged

Confusion

Sinus bradycardia

Fatigue

Injection site reaction

Cytokine release syndrome

Infection

Peripheral nerve infection

Anorexia

Insomnia

Hypercalcemia

Hemorrhage

100%

80%

60%

40%

20%

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

1Treatment groups

Experimental Treatment

Group I: Treatment (MV-NIS infected mesenchymal stem cells)Experimental Treatment10 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiography

2013

Completed Phase 4

~11580

Multigated Acquisition Scan

2015

Completed Phase 3

~270