Oncolytic Measles Virus Therapy for Ovarian Cancer

No longer recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Corticosteroids, Anticoagulants

Disqualifiers: CNS metastases, Cardiac disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for ovarian, fallopian tube, or peritoneal cancer using a specially modified measles virus. The virus targets and kills cancer cells while sparing healthy ones. Participants will receive either this oncolytic virus treatment or standard chemotherapy, which includes drugs like paclitaxel (Taxol) and bevacizumab (Avastin), to compare effectiveness. Ideal candidates have recurrent or persistent cancer that did not fully respond to previous treatments and have undergone surgery to remove their ovaries. This trial may suit those who meet these criteria and are interested in a novel treatment approach. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that any concurrent medications which could interfere with the trial are not allowed. It's best to discuss your specific medications with the trial team to see if they might interfere.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments using the oncolytic measles virus, such as MV-NIS, have been safe and well-tolerated in past studies. For instance, early trials with different versions of the measles virus in other cancers generally did not cause severe side effects, suggesting MV-NIS might be safe for humans.

Chemotherapy options like pegylated liposomal doxorubicin, gemcitabine, topotecan, paclitaxel, and bevacizumab have been used in other treatments and are FDA-approved for various cancers. Patients often tolerate them well, although side effects can occur. These may include tiredness, nausea, or low blood counts, but doctors monitor these closely.

Overall, evidence suggests these treatments have been safe in previous uses, but personal experiences may vary. Clinical trial participants are monitored closely to manage any side effects that occur. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for ovarian cancer, which typically involve chemotherapy drugs like paclitaxel and bevacizumab, the oncolytic measles virus therapy (MV-NIS) offers a novel approach. This therapy uses a genetically modified virus that selectively infects and destroys cancer cells while sparing healthy ones. Additionally, MV-NIS is delivered directly into the abdomen, allowing for targeted action at the site of the tumor. Researchers are excited because this method harnesses the body's natural viral mechanisms to attack cancer cells, potentially leading to fewer side effects and improved outcomes compared to traditional chemotherapy.

What evidence suggests that this trial's treatments could be effective for ovarian cancer?

Studies have shown that MV-NIS, a modified measles virus, can effectively target and destroy cancer cells in ovarian cancer. Researchers have altered this virus to attack only cancer cells, sparing healthy ones. In this trial, some participants will receive MV-NIS as a treatment option. Research suggests that combining MV-NIS with standard treatments may improve outcomes. Some patients with ovarian cancer unresponsive to common chemotherapy have shown positive responses to MV-NIS treatment. This indicates that MV-NIS could be a promising option for those with limited success from other therapies. ^{1 3 6 7 8}

Who Is on the Research Team?

Evanthia Galanis

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Willingness to return for follow-up and provide biologic specimens as required

Exclusion Criteria

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

I meet the health and treatment history requirements for safety.

I cannot stop my blood thinner medication for up to 7 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive either MV-NIS therapy or investigator's choice chemotherapy. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months until disease progression and then every 6 months for up to 5 years.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Bevacizumab
• Gemcitabine Hydrochloride
• MV-NIS
• Paclitaxel
• Pegylated Liposomal Doxorubicin Hydrochloride
• Topotecan Hydrochloride

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm A (MV-NIS) Experimental Treatment 3 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 Control 7 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.

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

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+

Published Research Related to This Trial

In a study of 114 patients with advanced ovarian cancer treated with carboplatin, paclitaxel, and bevacizumab, 41% experienced arthralgia (joint pain), indicating it is a common side effect of this treatment.

Although patients with arthralgia had a median progression-free survival of 29 months compared to 18 months for those without, this difference was not statistically significant when accounting for other factors, suggesting that while arthralgia is prevalent, it may not directly impact long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthralgia in patients with ovarian cancer treated with bevacizumab and chemotherapy. Ventriglia, J., Paciolla, I., Pisano, C., et al.[2021]

In a study of 164 patients with recurrent ovarian cancer, the combination of bevacizumab (BEV) with paclitaxel and carboplatin significantly improved progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) compared to the control group receiving only paclitaxel and carboplatin.

The experimental group experienced fewer adverse reactions, such as allergies and gastrointestinal issues, and showed a significant improvement in quality of life after treatment, indicating that BEV combined with paclitaxel is both effective and safer for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effect of bevacizumab combined with paclitaxel and carboplatin on recurrent ovarian cancer. Cong, J., Liu, R., Hou, J., et al.[2020]

Bevacizumab has been shown to be effective in managing epithelial ovarian cancer, particularly when combined with cytotoxic chemotherapy, as indicated by phase III trial data that demonstrate improved progression-free survival.

There is a compelling argument for using bevacizumab as a single agent in patients with platinum-resistant ovarian cancer, suggesting a more rational and potentially cost-effective approach to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of bevacizumab in the management of ovarian cancer: an argument for single-agent rather than combination therapy. Markman, M.[2020]

Despite high initial response rates to surgery and platinum-based chemotherapy in ovarian cancer, most patients experience relapse, highlighting the need for new treatment strategies to improve survival.

Recent phase III trials have shown that the anti-angiogenic agent bevacizumab, when used alongside chemotherapy and as maintenance therapy, can positively impact outcomes in first-line ovarian cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal first-line treatment in ovarian cancer. Raja, FA., Chopra, N., Ledermann, JA.[2022]

Docetaxel has shown comparable effectiveness to paclitaxel when combined with carboplatin for treating advanced ovarian cancer, with a potentially better safety profile.

Current treatments for platinum-resistant ovarian cancer are limited, and while some experimental therapies targeting the epidermal growth factor receptor show promise, more research is needed to find effective new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New aspects by the therapy of ovarian cancer--What changes after the ASCO-Meeting 2001]. Costa, SD., von Minckwitz, G., Wernicke, K., et al.[2008]

Bevacizumab, when combined with carboplatin and paclitaxel, significantly prolongs progression-free survival in women with newly diagnosed advanced ovarian cancer, as shown in the GOG-0218 and ICON7 studies.

In patients with recurrent platinum-sensitive ovarian cancer, bevacizumab combined with carboplatin and gemcitabine also extends progression-free survival, demonstrating its efficacy in both first-line and second-line treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab combination therapy: a review of its use in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Dhillon, S.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4377302/

Oncolytic Measles Virus Expressing the Sodium Iodide ... Here, we report results from a clinical evaluation of MV-NIS in patients with taxol- and platinum-resistant ovarian cancer. MV-NIS was given intraperitoneally ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02068794

NCT02068794 | MV-NIS Infected Mesenchymal Stem Cells ... Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian, primary peritoneal and fallopian tube cancer cells. Detailed ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3300082/

Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide ... MV-NIS could be a promising new anticancer agent that may substantially enhance the outcomes of standard therapy after intratumoral administration.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02364713

Study Details | NCT02364713 | MV-NIS or Investigator's ... This randomized phase II trial studies how well oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) compared to investigator's choice ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20112279

MV-NIS Infected Mesenchymal Stem Cells in Treating ... Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian cancer cells. Participation eligibility. Participant eligibility ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9515431/

Safety study supports clinical development of ... Previous early-phase clinical trials have demonstrated safety and tolerability of other MV derivatives in other tumor entities.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2329050122001061

Preclinical safety assessment of MV-s-NAP, a novel ... We engineered an MV strain to express the secretory form of NAP (MV-s-NAP) and showed that it exhibits anti-tumor and immunostimulatory activity in human ...

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2014-00016

MV-NIS Infected Mesenchymal Stem Cells in Treating ... Mesenchymal stem cells may be able to carry tumor-killing substances directly to ovarian, primary peritoneal and fallopian tube cancer cells. Eligibility ...