Vaccine Therapy in Treating Patients with Malignant Peripheral Nerve Sheath Tumor That is Recurrent or Cannot Be Removed by Surgery
NCT02700230 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2024-09-27
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.
Conditions
- Metastatic Malignant Peripheral Nerve Sheath Tumor
- Neurofibromatosis Type 1
- Recurrent Malignant Peripheral Nerve Sheath Tumor
Interventions
- PROCEDURE
-
Computed Tomography
Undergo CT scan
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- BIOLOGICAL
-
Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter
Given intratumorally
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
- PROCEDURE
-
Single Photon Emission Computed Tomography
Undergo SPECT imaging
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Ultrasound Imaging
Undergo ultrasound imaging
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- PROCEDURE
-
Biopsy
Undergo tissue biopsy
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Dusica Babovic-Vuksanovic, MD · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-22
- Primary Completion
- 2024-04-17
- Completion
- 2024-04-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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