Brain Tumor. Malignant neoplasm of brain
Conditions
Interventions
Intervention group: Local inoculation of oncolytic virus at the tumor site.
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Histologically confirmed recurrent or residual glioblastoma that is progressive despite prior or ongoing radiation therapy. An enhanced lesion measuring one centimeter or more in diameter on MRI with contrast Karnofsky Performance Scale (KPS) >=70% Age greater than or equal to 18 years Willing to use effective contraception for at least 6 months after oncolytic virus administration Expected survival greater than 3 months Absolute neutrophil count (ANC) >= 1500/uL Platelets (PLT) >= 100,000/uL Total bilirubin == 1.1 EU/ml, determined by enzyme-linked immunosorbent assay Normal serum CEA level (<3 ng/mL) at baseline Negative serum pregnancy test performed <= 7 days prior to study entry (only for women of childbearing age) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2 Informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Multiple (more than one) intracranial malignant glioma lesions Documented extracranial metastases Laboratory test values ??for CBC, platelets, clinical chemistry, liver and kidney function tests outside the protocol-specified limits Chemotherapy, cytotoxic, or immunotherapy within 6 weeks prior to oncolytic virus administration Any contraindications for MRI, such as pacemakers, infusion pumps, etc. Surgery within 4 weeks before oncolytic virus administration Pregnant or breastfeeding women Active infection = < 5 days prior to study start History of tuberculosis or history of positive purine protein derivative (PPD) tests Chemotherapy =< 4 weeks prior to study start (6 weeks for nitrosourea-based chemotherapy) Immunotherapy =< 4 weeks before study start Biological therapy =< 4 weeks before study start Bevacizumab =< 12 weeks prior to study start Administration of non-cytotoxic antitumor drugs, i.e. small molecule cell cycle inhibitors, less than 2 weeks before the start of the study Radiation therapy =< 6 weeks prior to study start Failure to fully recover from the acute and reversible effects of previous chemotherapy, regardless of the time interval since the last treatment. Inadequate seizure control History of organ transplantation History of chronic hepatitis B or American Society of Anaesthesiology (ASA) Class 3 or 4 Allergy to measles vaccine or history of severe reaction to previous measles vaccination History of any of the following: HIV, use of other investigational agents or vaccination within 30 days; encephalitis, multiple sclerosis or other CNS infections; previous gene transfer therapy or previous treatment with a cytolytic virus of any type
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient survival time. Timepoint: Every month as long as the patient survives?. Method of measurement: Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the volume of the enhanced area in MRI. Timepoint: ?????? ?? ???? ???? ????? ?????. Method of measurement: Review of MRI images. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamid Reza Khayat Kashani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed