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NCT02700230CompletedPhase 1

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

Source: ClinicalTrials.gov · Last updated 27 Sept 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
9 (actual)
First submitted
25 Feb 2016
Start date
22 Mar 2017
Primary completion date
17 Apr 2024
Lead sponsor
Mayo Clinic
Diseases
Sarcoma
NCT number
NCT02700230

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 9
  • From 22 Mar 2017 to the primary completion date, 17 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior 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
  • 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
  • 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
  • Allergy to measles vaccine or history of severe reaction to prior measles vaccination

Other illness

  • History of tuberculosis or history of purified protein derivative (PPD) positivity
  • 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
  • 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)

Other

  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
    • 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
  • Requiring blood product support
  • 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

Who the study is looking for

  • Age \>= 18 years
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.