Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
Condition: Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Mixed Glioma; Recurrent Glioblastoma
MeSH terms: Glioblastoma; Astrocytoma; Oligodendroglioma; Glioma; Recurrence
Intervention: Carcinoembryonic Antigen-Expressing Measles Virus; Laboratory Biomarker Analysis; Therapeutic Conventional Surgery
Intervention description: Given via injection into resection cavity or around tumor bed and/or IT; Correlative studies; Undergo en bloc resection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  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