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Recurrent Malignant MesotheliomaPhase 1NCT01503177

Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma

A Phase 1 study testing oncolytic measles virus encoding thyroidal sodium iodide symporter, laboratory biomarker analysis and single photon emission computed tomography in people with Recurrent Malignant Mesothelioma and Stage IA Malignant Mesothelioma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I clinical trial investigates the side effects and the best dose of local (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma (MPM). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
oncolytic measles virus encoding thyroidal sodium iodide symporter, laboratory biomarker analysis and single photon emission computed tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Nov 2011to 11 Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • PRE-REGISTRATION:
  • Diagnosis of MPM, confined to single pleural cavity, with histologic confirmation of the primary tumor
  • Measurable disease per modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for mesothelioma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic Rochester or the University of Minnesota Cancer Center for follow up
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  • Life expectancy >= 12 weeks (in the opinion of the enrolling investigator)
  • Willingness to provide the biologic specimens and participate in the SPECT/CT imaging as required by the protocol
  • Presence of a pleural effusion with the ability to safely place an intrapleural catheter or have pre-existing intrapleural catheter
  • Absolute neutrophil count (ANC) >= 1500/μL
  • Platelet count >= 100,000/μL
  • Total bilirubin =< 1.5 x upper limit of institutional normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 2 x upper limit of institutional normal
  • Serum Creatinine =< 1.5 x upper limit of institutional normal
  • Hemoglobin >= 9.0 g/dL
  • Must be willing to implement contraception throughout study and for the 4 weeks following last viral administration
  • REGISTRATION:
  • Anti-measles immunity as demonstrated by serum IgG anti-measles antibody levels of ≥ 1.1 EU/ml as determined by BioPlex Measles IgG multiplex flow immunoassay.
  • Hepatitis B and C negative
  • Human immunodeficiency virus (HIV) negative
  • CD4 count >= 200/μL
  • CT imaging review submission to confirm unilateral pleural involvement; this review for CT imaging is mandatory prior to registration to confirm eligibility; it should be initiated as soon as possible after pre-registration
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only

Who cannot join

  • PRE-REGISTRATION
  • Uncontrolled intercurrent illness including, but not limited to:
  • Active infection =< 5 days prior to pre-registration
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • Symptomatic congestive heart failure New York Heart Association classification III or IV
  • Symptomatic coronary artery disease (CAD)
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  • Symptoms of CAD on systems review
  • Cardiac arrhythmias
  • Any of the following therapies prior to pre-registration:
  • Chemotherapy =< 4 weeks
  • Immunotherapy =< 4 weeks
  • Biologic therapy =< 4 weeks; Note exception: prior viral and/or gene therapy are exclusion criteria
  • Radiotherapy =< 4 weeks Failure to fully recover from acute, reversible effects of prior anti-cancer therapy regardless of interval since last treatment; NOTE: patients must have fully recovered from all acute, reversible toxicities (defined as Common Terminology Criteria for Adverse Events [CTCAE] 4.0 =< grade 1) associated with previous treatment
  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • Any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA] approved indication and in the context of a research investigation) or any other treatment specifically for treating the current malignancy
  • Immunocompromised patients, including patients known to be HIV positive
  • Other active malignancy =< 2 years prior to pre-registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix
  • History of organ transplantation
  • Known hepatitis B or C
  • Treatment with oral/systemic corticosteroids; NOTE: with the exception of topical or inhaled steroids
  • Exposure to household contacts =<15 months old or household contact with a person with known immunodeficiency
  • Allergy to measles vaccine or history of severe reaction to prior measles vaccination
  • Allergy to iodine; NOTE: this does not include reactions to intravenous contrast materials
  • History of tuberculosis or purified protein derivative (PPD) skin test positivity
  • Inability or unwillingness to have pleural catheter placed
  • Requiring ongoing blood product support at time of pre-registration

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase 1 Trial of Oncolytic Measles Virotherapy in Mesothelioma

This phase I clinical trial investigates the side effects and the best dose of local (intrapleural measles virus therapy in treating patients with malignant pleural mesothelioma (MPM). The investigators anticipate that the intrapleural of the vaccine strain measles virus will enable the virus to specifically infect and kill cancer cells and spare, without damaging normal cells. Furthermore, the investigators expect the measles virus to trigger an anti-tumor immune response which will result in additional destruction of the tumor by immune cells

Read the detailed description

PRIMARY OBJECTIVES:

Maximum tolerated dose (MTD) for the intrapleural administration of a modified vaccine strain measles virus (MV) genetically engineered to produce human thyroidal sodium iodine symporter (NIS) (MV-NIS [oncolytic measles virus encoding thyroidal sodium iodide symporter])in patients with MPM.

SECONDARY OBJECTIVES:

Safety and toxicity of the repeated (up to 6 cycles) intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma.

TERTIARY OBJECTIVES:

  1. Time course of viral infection, dissemination and elimination by non-invasive measurements of NIS gene expression using radioactive iodine and single-photon emission computed tomography (SPECT)/ computed tomography (CT) imaging with.

II. Viremia, viral replication, and viral shedding following intrapleural administration.

III. Changes in humoral and cellular anti-MV immunity following the intrapleural administration of MV-NIS.

IV. Antitumor efficacy of this approach by serial measurements of radioiodine uptake by SPECT/CT, radiographic response, and time to disease progression.

  1. Changes in both local and systemic innate and adaptive anti-tumor immunity following the intrapleural administration of MV-NIS.

VI. Effect of MV-NIS administration on the eukaryotic initiation factor (eIF) 4F translation complex in mesothelioma cells.

OUTLINE: This is a dose-escalation study.

Patients receive the oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) intrapleurally. In the absence of unacceptable side effects or disease progression treatment can be repeated every 28 days for up to 6 courses.

After completion of study treatment, patients are followed up every 3 to 6 months for up to 5 years.

Being tested
oncolytic measles virus encoding thyroidal sodium iodide symporter, laboratory biomarker analysis, single photon emission computed tomography, computed tomography
Medical subject headings
Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oncolytic measles virus encoding thyroidal sodium iodide symporterBiological

    Also called MV-NIS

    Given intrapleurally

  • laboratory biomarker analysisOther

    Correlative studies

  • single photon emission computed tomographyProcedure or surgery

    Also called SPECT imaging, tomography, emission computed, single photon

    Correlative studies

  • computed tomographyProcedure or surgery

    Also called tomography, computed

    Correlative studies

Study groups in NCT01503177
Study groupRoleWhat they receive
Treatment (viral therapy)ExperimentalPatients receive MV-NIS intrapleurally on day 1. Treatment repeats every 28 days for up to 6 courses in absence of disease progression or unacceptable toxicity.
Receives: Biological: oncolytic measles virus encoding thyroidal sodium iodide symporter; Other: laboratory biomarker analysis; Procedure: single photon emission computed tomography; Procedure: computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse event (AE) profile

    The number and severity of toxicity incidents will indicate the level of tolerance for MV-NIS in the therapy of MPM. Non-hematologic toxicities will be evaluated via the CTCAE v4.0 standard toxicity grading. Hematologic toxicity measures such as anemia, neutropenia and thrombocytopenia will be assessed using continuous variables as the outcome measures (nadir and percent change from baseline values) as well as categorization via CTCAE v4.0 standard toxicity grading. Frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

    Measured: 90 Days

Secondary outcomes (1)

  1. Describe the safety of the intrapleural administration of MV-NIS in patients with malignant pleural mesothelioma for all cycles out to 90 days.

    The number and severity of adverse events (AE) over the course of up to 6 cycles of MV-NIS therapy will indicate the level of tolerance for MV-NIS in the therapy of MPM. AE will be evaluated similar to the primary outcome via the CTCAE v4.0 standard toxicity grading and frequency distributions and other descriptive measures will form the basis of the analysis of these variables.

    Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2012 (estimated)
  2. Study startNov 2011
  3. Primary completion11 Apr 2019
  4. Study completion11 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01503177
Sponsor's protocol ID
MC1023
Other IDs
NCI-2011-03574
Status last verified
Jan 2021
First submitted
16 Dec 2011
Last updated
11 Jan 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing oncolytic measles virus encoding thyroidal sodium iodide symporter, laboratory biomarker analysis and single photon emission computed tomography in people with Recurrent Malignant Mesothelioma and Stage IA Malignant Mesothelioma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse event (AE) profile (time frame: 90 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01503177.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021.

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