Clinical Study on the Safety and Efficacy of Novel Oncolytic Virus in the Treatment of Recurrent Malignant Glioma

Korábbi kezelés

• Prior history of encephalitis, multiple sclerosis, or other CNS infection;

Más betegség

• Herpes simplex virus infection active period;
• Patients with a history of organ transplantation or waiting for an organ transplant;
• Uncontrollable infectious diseases or other serious diseases such as HIV positive;
• Severe pulmonary, cardiac or other systemic disease, specifically: Including active infections, uncontrolled high blood pressure, unstable angina pectoris, angina pectoris that began to develop within the last 3 months, congestive heart failure, myocardial infarction that occurred within the first 12 months of enrollment, requiring serious;medical treatment Arrhythmia, liver, kidney failure, etc.;
• Patients with systemic autoimmune disease or immunodeficiency disease;
• Patients with severe allergies;
• Patients with chronic diseases requiring long-term immunologic preparation or glucocorticoid therapy.

Egyéb

• Pregnant or lactating women;

• Patients has given written informed consent；
• Age is between 18 years old and 75 years old, inclusive;
• Patients must have histologically or cytologically confirmed Glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendrocyte-glioma;
• Residual lesion must be ≥1.0 cm in diameter as determined by MRI;
• Karnofsky Performance Status ≥70%;
• Patients must have normal organ and marrow function. Absolute neutrophil count: ≥ 1,500/mm3, Hemoglobin>10 g/dL platelets: >100,000/mm3, total bilirubin< 1.5 ×ULN; AST(SGOT)(aspartate aminotransferase)/ALT(SGPT)(alanine aminotransferase): <2.5 X institutional upper limit of normal; Serum creatinine < 1.5 ×ULN, and normal heart function;
• Good compliance: can actively cooperate with doctors' treatment and follow-up survey;
• Females of childbearing potential must not be pregnant; this will be confirmed by a negative serum pregnancy test within 7 days prior to starting study treatment and must use a birth control method in addition to barrier methods (condoms).