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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

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I have had both of my ovaries surgically removed.

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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:

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My cancer can be measured and is outside the belly area.

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My cancer did not respond to certain chemotherapy treatments.

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

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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

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

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

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

0 / 6Eligibility criteria met