Clinical Trials Directory

Trials / Completed

CompletedNCT02700230

Vaccine Therapy in Treating Patients with Malignant Peripheral Nerve Sheath Tumor That is Recurrent or Cannot Be Removed by Surgery

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
9 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREComputed TomographyUndergo CT scan
OTHERLaboratory Biomarker AnalysisCorrelative studies
BIOLOGICALOncolytic Measles Virus Encoding Thyroidal Sodium Iodide SymporterGiven intratumorally
OTHERQuality-of-Life AssessmentAncillary studies
PROCEDURESingle Photon Emission Computed TomographyUndergo SPECT imaging
PROCEDUREMagnetic Resonance ImagingUndergo MRI
PROCEDUREUltrasound ImagingUndergo ultrasound imaging
PROCEDUREBiospecimen CollectionUndergo blood sample collection
PROCEDUREBiopsyUndergo tissue biopsy
OTHERQuestionnaire AdministrationAncillary studies

Timeline

Start date
2017-03-22
Primary completion
2024-04-17
Completion
2024-04-17
First posted
2016-03-07
Last updated
2024-09-27

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02700230. Inclusion in this directory is not an endorsement.