Ensayos clínicos

Inclusion Criteria:

• PLT ≥ 100,000/uL
• Must have central review prior to registration
• Candidate for gross total or subtotal resection
• Ability to provide informed consent
• Willing to provide biological specimens as required by the protocol
• Normal serum CEA level (< ng/ml) at the time of registration
• Recurrent grade 4 astrocytoma and grade 4 gliosarcoma with histological confirmation at primary diagnosis and/or recurrence
• Negative serum pregnancy test done ≤ 7 days prior to registration (for women of childbearing potential only)
• Anti-measles virus immunity as demonstrated by IgG anti-measles antibody levels of ≥ 20 EU/ml as determined by Enzyme Immunoassay
• Grade 3 astrocytoma patients with clinical or imaging characteristics suggestive of progression to grade 4 are eligible, provided that the diagnosis of grade 4 astrocytoma is confirmed by biopsy (including confirmation in frozen section) prior to viral administration
• Total bilirubin ≤ 1.5 x upper normal limit (ULN)
• AST ≤ 2 x ULN
• Creatinine ≤ 2.0 x ULN
• Hgb ≥ 9.0 gm/dL
• PT and aPTT ≤ 1.3 x ULN
• ECOG performance status (PS) 0, 1 or 2
• ANC ≥ 1500/uL

Exclusion Criteria:

• Pregnant women
• Nursing women
• 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 IV
• Requiring blood product support
• Inadequate seizure control
• Expected communication between ventricles and resection cavity as a result of surgery
• History of organ transplant
• History of chronic hepatitis B or C
• Exposure to household contact ≤ 15 months old or household contact with known immunodeficiency
• Allergy to measles vaccine or history of severe reaction to prior measles vaccination
• Chemotherapy ≤ 4 weeks prior to registration (6 wks for nitrosourea-based chemotherapy)
• Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-FDA -approved indication and in the context of research investigation)
• History of tuberculosis or history of PPD positivity
• Biologic therapy ≤ 4 weeks prior to registration
• Non-cytotoxic antitumor drugs (i.e., small molecular cell cycle inhibitors) ≤ 2 weeks prior to registration
• HIV-positive test result or history of other immunodeficiency
• Men or women of childbearing potential who are unwilling to employ adequate contraception
• Active infection ≤ 5 days prior to registration
• Immunotherapy ≤ 4 weeks prior to registration