Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme

Completed · Phase 1

Conditions studied: Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Mixed Glioma, Recurrent Glioblastoma

In brief

This phase I trial studies the side effects and best dose of carcinoembryonic antigen-expressing measles virus (MV-CEA) in treating patients with glioblastoma multiforme that has come back. A virus, called MV-CEA, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells.

Key facts

Study ID

NCT00390299

Run by

Mayo Clinic

People needed

23

Starts

2006-10-23

Expected to finish

2019-11-30

Last updated by the study team

2020-01-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recurrent grade 3 or 4 glioma, including astrocytoma, oligodendroglioma or mixed glioma with histologic confirmation at initial diagnosis or recurrence
• Candidate for gross total or subtotal resection
• Absolute neutrophil count (ANC) >= 1500/uL
• Platelets (PLT) >= 100,000/uL
• Total bilirubin =< 1.5 x upper normal limit (ULN)
• Aspartate aminotransferase (AST) =< 2 x ULN
• Creatinine =< 2.0 x ULN
• Hemoglobin (Hgb) >= 9.0 gm/dL
• Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.3 x ULN
• Ability to provide informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• Anti-measles virus immunity as demonstrated by immunoglobulin G (IgG) anti-measles antibody levels of >= 1.1 EU/ml as determined by enzyme immunoassay
• Normal serum CEA levels (< 3 ng/ml) at the time of registration
• Willing to provide biologic specimens as required by the protocol
• Negative serum pregnancy test done =< 7 days prior to registration (for women of childbearing potential only)

You may not qualify if…

• Any of the following:
• Pregnant women
• Nursing women
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Active infection =< 5 days prior to registration
• History of tuberculosis or history of purified protein derivative (PPD) positivity
• Any of the following therapies:
• Chemotherapy =< 4 weeks prior to registration (6 wks for nitrosourea-based chemotherapy)
• Immunotherapy =< 4 weeks prior to registration
• Biologic therapy =< 4 weeks prior to registration
• Bevacizumab =< 12 weeks prior to registration
• Non-cytotoxic antitumor drugs, i.e., small molecule cell cycle inhibitors =< 2 weeks prior to registration
• Radiation therapy =< 6 weeks prior to registration
• Any viral or gene therapy prior to registration
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• New York Heart Association classification III or IV
• Requiring blood product support
• Inadequate seizure control
• Expected communication between ventricles and resection cavity as a result of surgery
• 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)
• Exposure to household contacts =< 15 months old or household contact with known immunodeficiency
• Allergy to measles vaccine or history of severe reaction to prior measles vaccination

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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