Vaccine Therapy in Treating Patients with Malignant Peripheral Nerve Sheath Tumor That is Recurrent or Cannot Be Removed by Surgery
NCT ID: NCT02700230
Last Updated: 2024-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2017-03-22
2024-04-17
Brief Summary
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Detailed Description
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I. To determine the maximum tolerated dose (MTD) of intratumoral administration of an Edmonston strain measles virus genetically engineered to express neurofibromatosis type 1 (NIS) (oncolytic measles virus encoding thyroidal sodium iodide symporter \[MV-NIS\]) in patients with inoperable or recurrent malignant peripheral nerve sheath tumor (MPNST).
II. To determine the safety and toxicity of intratumoral administration of MV-NIS in patients with inoperable recurrent MPNST.
III. To preliminarily assess antitumor efficacy of intratumoral MV-NIS administration by the rate of progression-free survival at 3 months, achieved by following radiographic response of the treated lesion using World Health Organization (WHO) response criteria guidelines.
SECONDARY 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. IV. To assess the quality-of-life of patients treated with MV-NIS, using two inventories (Pain and Fatigue).
V. To assess time to progression and differences in growth rates between treated and untreated tumor lesions.
VI. To assess the overall survival time of patients treated with MV-NIS.
OUTLINE:
Patients receive MV-NIS intratumorally on day 1. Patients also undergo SPECT/CT at baseline and at 3 and 8 days after MV-NIS. Patients may also undergo SPECT/CT at 15 and 28 days, and at 6 weeks based on whether there is uptake on prior imaging studies. Patients also undergo magnetic resonance imaging (MRI), ultrasound imaging, blood sample collection and tissue biopsy throughout the trial.
After completion of study treatment, patients are followed up at 3, 6, 12, 18, and 24 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (MV-NIS)
Patients receive MV-NIS intratumorally on day 1. Patients also undergo SPECT/CT at baseline and at 3 and 8 days after MV-NIS. Patients may also undergo SPECT/CT at 15 and 28 days, and at 6 weeks based on whether there is uptake on prior imaging studies. Patients also undergo MRI, ultrasound imaging, blood sample collection and tissue biopsy throughout the trial.
Computed Tomography
Undergo CT scan
Laboratory Biomarker Analysis
Correlative studies
Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
Given intratumorally
Quality-of-Life Assessment
Ancillary studies
Single Photon Emission Computed Tomography
Undergo SPECT imaging
Magnetic Resonance Imaging
Undergo MRI
Ultrasound Imaging
Undergo ultrasound imaging
Biospecimen Collection
Undergo blood sample collection
Biopsy
Undergo tissue biopsy
Questionnaire Administration
Ancillary studies
Interventions
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Computed Tomography
Undergo CT scan
Laboratory Biomarker Analysis
Correlative studies
Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
Given intratumorally
Quality-of-Life Assessment
Ancillary studies
Single Photon Emission Computed Tomography
Undergo SPECT imaging
Magnetic Resonance Imaging
Undergo MRI
Ultrasound Imaging
Undergo ultrasound imaging
Biospecimen Collection
Undergo blood sample collection
Biopsy
Undergo tissue biopsy
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed MPNST, with or without underlying diagnosis of neurofibromatosis type 1 (diagnostic criteria for neurofibromatosis type 1)
* Measurable disease as defined by at least one tumor that is measurable in two dimensions on CT or magnetic resonance imaging (MRI) scan (minimum size 1.0 cm for at least one lesion)
* MPNST for which standard therapy is not curative, including patients with surgically unresectable lesions, progression (WHO criteria) or recurrence of an MPNST in a previously radiated field (if it has been at least 4 weeks prior to registration since the last dose of radiation); Note: patients with metastatic disease also are eligible for participation
* Patient may have more than one site of recurrent or metastatic disease but only one lesion that is \>= 1 cm in size will be injected (if in the lung, the lesion must be \>= 2 cm and adjacent to the pleura in the lung)
* The following laboratory values obtained =\< 14 days prior to registration
* Absolute neutrophil count (ANC) \>= 1500
* Platelet (PLT) \>= 100,000
* 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 upper limit of normal (ULN)
* Creatinine =\< 1.0 mg/dL
* International normalized ratio (INR) =\< 2.0
* 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 Rochester for follow-up
* Willingness to provide biologic samples for correlative research purposes
* Life expectancy \>= 12 weeks
* Cluster of differentiation (CD)4 count \>= 200/uL or \>= 15% of peripheral blood lymphocytes
* Ability to complete questionnaire(s) by themselves or with assistance
Exclusion Criteria
* 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, heparin, apixaban, dabigatran, rivaroxaban, warfarin)
* Active infection =\< 5 days prior to registration
* History of tuberculosis or history of 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
* 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 except alopecia and neuropathy
* Requiring blood product support
* Patient has central nervous system (CNS) metastases or seizure disorder. Note: Patients with seizures controlled by medication are eligible.
* 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; NOTE: patient must avoid contact during documented viral shedding; participants with continuous viral shedding will be given recommendations for restricted activities to avoid contact with immunocompromised persons
* 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
* Allergy to lidocaine, fentanyl, midazolam, or propofol (may be used during tumor biopsy or injection)
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Dusica Babovic-Vuksanovic, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Hassan A, Pestana RC, Parkes A. Systemic Options for Malignant Peripheral Nerve Sheath Tumors. Curr Treat Options Oncol. 2021 Feb 27;22(4):33. doi: 10.1007/s11864-021-00830-7.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2016-00179
Identifier Type: REGISTRY
Identifier Source: secondary_id
MC1372
Identifier Type: OTHER
Identifier Source: secondary_id
W81XWH-15-1-0115
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
15-008308
Identifier Type: OTHER
Identifier Source: secondary_id
MC1372
Identifier Type: -
Identifier Source: org_study_id
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