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Estrogen Receptor NegativePhase 1NCT01846091

Viral Therapy In Treating Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Cancer or Metastatic Breast Cancer

A Phase 1 study testing Laboratory Biomarker Analysis and Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter in people with Estrogen Receptor Negative and Estrogen Receptor Positive, 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 trial studies the side effects and the best dose of viral therapy in treating patients with squamous cell carcinoma of the head and neck that has returned (come back) after a period of improvement or has spread to other parts of the body or breast cancer that has spread to other parts of the body. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis and Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
9 Apr 2013to 26 Nov 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

  • Pathologically confirmed squamous cell carcinoma of the head and neck OR pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2) status and radiographic evidence of distant metastatic disease
  • Measurable disease
  • Head and neck cancer OR metastatic breast for which standard therapy is not curative *NOTE: Patients with ER/PR positive, HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease and no longer be candidates for standard endocrine therapy; patients with HER2 positive breast cancer irrespective of ER/PR status must have received or no longer be candidates for standard HER2 directed therapy (i.e., trastuzumab, pertuzumab, trastuzumab emtansine, and lapatinib); patients with ER/PR/HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease; ER/PR and HER2 status are defined by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
  • Patient may have more than one site of recurrence/metastatic disease but only one lesion will be injected that is >= 1 cm in size (if in the lung, the lesion must be >= 2 cm and adjacent to the pleura in the lung)
  • Absolute neutrophil count (ANC) >= 1500
  • Platelet (PLT) >= 100,000
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  • Hemoglobin (HgB) > 9.0 g/dL
  • Total bilirubin =< institutional upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN
  • Creatinine =< 1.0 mg/dL
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • Provide informed written consent
  • Willingness to return to Mayo Clinic enrolling institution for follow-up
  • Willingness to provide biologic samples for correlative research purposes
  • Life expectancy >= 12 weeks

Who cannot join

  • Any of the following * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of treatment
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Receiving therapeutic anticoagulation (Coumadin or low molecular weight heparin)
  • Active infection =< 5 days prior to registration
  • History of tuberculosis or history of tuberculin purified protein derivative (PPD) positivity
  • Any of the following prior therapies: * Chemotherapy =< 3 weeks prior to registration * Immunotherapy =< 4 weeks prior to registration * Biologic therapy =< 4 weeks prior to registration * Radiation therapy =< 3 weeks prior to registration
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  • Failure to fully recover from acute, reversible effects defined as =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 of prior chemotherapy regardless of interval since last treatment
  • Requiring blood product support
  • Central nervous system (CNS) metastases or seizure disorder
  • Human immunodeficiency virus (HIV)-positive test result, or history of other immunodeficiency
  • History of organ transplantation
  • History of chronic hepatitis B or C
  • 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)
  • Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids
  • Current exposure to household contacts =< 15 months old or household contact with known immunodeficiency
  • Willing to avoid household contacts =< 15 months old or household contact with known immunodeficiency 1 week after treatment
  • 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

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: Phase I Trial of Intratumoral Administration of a NIS-Expressing Derivative Manufactured From a Genetically Engineered Strain of Measles Virus in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck or Metastatic Breast Cancer

This phase I trial studies the side effects and the best dose of viral therapy in treating patients with squamous cell carcinoma of the head and neck that has returned (come back) after a period of improvement or has spread to other parts of the body or breast cancer that has spread to other parts of the body. A virus called encoding thyroidal sodium iodide symporter, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.

Read the detailed description

PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of intratumoral administration of an Edmonston strain measles virus genetically engineered to express human thyroidal sodium-iodide symporter (NIS) (oncolytic measles virus encoding thyroidal sodium iodide symporter [MV-NIS]) in patients with recurrent/metastatic squamous cell head and neck cancer. II. To determine the safety and toxicity of intratumoral administration of MV-NIS in patients with recurrent/metastatic squamous cell head and neck cancer and metastatic breast cancer. SECONDARY OBJECTIVES: I. To assess in a preliminary fashion antitumor efficacy of this approach by following, radiographic response, and time to progression. TERTIARY OBJECTIVES: I. To determine the time course of viral gene expression and virus elimination and biodistribution of virally infected cells at various time points after infection with MV-NIS using single-photon emission computed tomography (SPECT)/computed tomography (CT) imaging. II. To assess viremia, viral replication, and measles virus shedding/persistence following intratumoral administration. III. To determine humoral and cellular immune response to the injected virus. OUTLINE: This is a dose-escalation study. Patients receive oncolytic measles virus encoding thyroidal sodium iodide symporter intratumorally (IT) on day 1. After completion of study treatment, patients are followed up at 6 weeks, every 3 months for 1 year, and then every 6 months for 1 year.

Being tested
Laboratory Biomarker Analysis, Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Triple Negative Breast Neoplasms

What participants receive

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

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide SymporterBiological

    Also called MV-NIS

    Given IT

Study groups in NCT01846091
Study groupRoleWhat they receive
Treatment (MV-NIS)ExperimentalPatients receive oncolytic measles virus encoding thyroidal sodium iodide symporter IT on day 1.
Receives: Other: Laboratory Biomarker Analysis; Biological: Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter

What is being measured

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

  1. MTD defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) as assessed by the National Cancer (NCI) CTCAE v. 4.0

    Measured: 4 weeks

  2. Number of toxicity incidents defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment

    Assessed by the NCI CTCAE v. 4.0. Toxicity data will be summarized for MV-NIS virus cohorts.

    Measured: Up to 3 months

Secondary outcomes (2)

  1. Number of responses using Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1

    Responses will be summarized separately for MV-NIS virus by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease.

    Measured: Up to 2 years

  2. Time to tumor progression

    The time to tumor progression will be summarized by Kaplan-Meier curve.

    Measured: Up to 2 years

Timeline

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

  1. First posted3 May 2013 (estimated)
  2. Study start9 Apr 2013
  3. Primary completion18 Sep 2019
  4. Study completion26 Nov 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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01846091
Sponsor's protocol ID
MC0979
Other IDs
NCI-2013-00811, MC0979
Status last verified
Feb 2023
First submitted
1 May 2013
Last updated
14 Feb 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laboratory Biomarker Analysis and Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter in people with Estrogen Receptor Negative and Estrogen Receptor Positive, 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 16 inclusion and 18 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 14 Feb 2023. 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?

MTD defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) as assessed by the National Cancer (NCI) CTCAE v. 4.0 (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT01846091.

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 14 Feb 2023.

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