Status:
COMPLETED
Clinical Study on the Safety and Efficacy of Novel Oncolytic Virus in the Treatment of Recurrent Malignant Glioma
Lead Sponsor:
Beijing Neurosurgical Institute
Conditions:
Glioblastoma Multiforme
Gliomas, Malignant
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Glioma is the most common intracranial tumor. Among them, malignant glioma shows diffuse and infiltrating growth. Although it is given a comprehensive treatment such as surgery, radiotherapy and chemo...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Pregnant or lactating women;
- Prior history of encephalitis, multiple sclerosis, or other CNS infection;
- 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.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06562621
Start Date
August 1 2018
End Date
March 1 2024
Last Update
August 20 2024
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050