A Study of Vaccine Therapy in Treating Patients with Malignant Peripheral Nerve Sheath Tumors that are Recurrent or Cannot Be Removed by Surgery

Overview

About this study

The purpose of this study is to assess the side effects and best dose of a genetically engineered measles virus for treating patients who have a cancerous peripheral nerve sheath tumor that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)
  • Has metastatic disease
  • 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)
  • 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
  • Willing to return to Mayo Clinic Rochester for follow-up
  • Willing 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

  • Any of the following
    • 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
  • Has central nervous system metastases or seizure disorder
  • 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
    • Must avoid contact during documented viral shedding
    • If 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
    • Does not include reactions to intravenous contrast materials
  • Allergy to lidocaine, fentanyl, midazolam, or propofol (may be used during tumor biopsy or injection)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Dusica Babovic-Vuksanovic, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20308209

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