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Phase I Trial of Intratumoral Administration of a NIS-Expressing Derivative Manufactured from a Genetically Engineered Strain of Measles Virus in Patients with Unresectable or Recurrent Malignant Peripheral Nerve Sheath Tumor
This phase I trial studies the side effects and the best dose of a vaccine therapy in treating patients with malignant peripheral nerve sheath tumor that cannot be removed by surgery (unresectable) or has come back after a period of improvement (recurrent). Vaccines made from a gene-modified virus may kill tumor cells expressing a gene called neurofibromin 1 (NF1) without affecting surrounding normal cells and may also help the body build an effective immune response to kill tumor cells.
PRIMARY OBJECTIVES: 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic
Rochester, Minnesota, United States
Start Date
March 22, 2017
Primary Completion Date
April 17, 2024
Completion Date
April 17, 2024
Last Updated
September 27, 2024
9
ACTUAL participants
Computed Tomography
PROCEDURE
Laboratory Biomarker Analysis
OTHER
Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
BIOLOGICAL
Quality-of-Life Assessment
OTHER
Single Photon Emission Computed Tomography
PROCEDURE
Magnetic Resonance Imaging
PROCEDURE
Ultrasound Imaging
PROCEDURE
Biospecimen Collection
PROCEDURE
Biopsy
PROCEDURE
Questionnaire Administration
OTHER
Lead Sponsor
Mayo Clinic
NCT06541847
NCT07221331
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06507748