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IRCT20210712051848N3 IRCT 2025-01-19 Shahid Beheshti University of Medical Sciences Carcinoembryonic antigen-expressing oncolytic measles virus for the treatment of glioblastoma Local Carcinoembryonic antigen-expressing oncolytic measles virus for residual or recurrent glioblastoma: a phase1 and 2 study 2025-01-19 anticipated 43 Recruiting https://irct.ir/trial/81184 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Brain Tumor. Intervention group: Local inoculation of oncolytic virus at the tumor site. Yes - There is a plan to make this available What will be shared: All patient data, including clinical characteristics and radiological data, will be published after de-identification in an attachment to the publication of the article related to the project. When: At the time of publication of the relevant article To whom: Anyone who wants to can have access to the data. Conditions: Data is publicly available. Where to obtain: Data are available in the appendix of the relevant article. How to obtain: The data is publicly available in the appendix of the relevant article in the journal that publishes it. Comments:
public Hamid Reza Khayat Kashani
Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 hrkhka@gmail.com Shahid Beheshti University of Medical Sciences scientific Hamid Reza Khayat Kashani
Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 hrkhka@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 =< 1.5 times the upper limit of normal (ULN) Aspartate aminotransferase (AST) =< 2 x ULN Creatinine =< 2.0 x ULN Prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.3 x ULN Anti-measles viral immunity demonstrated by immunoglobulin (IgG) and anti-measles antibody levels >= 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 18 years no limit Both 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 C71 Malignant neoplasm of brain Treatment - Other Intervention group: Local inoculation of oncolytic virus at the tumor site Patient survival time. Timepoint: Every month as long as the patient survivesپ. Method of measurement: Questionnaire. Change in the volume of the enhanced area in MRI. Timepoint: ماهانه تا زمان زنده ماندن بیمار. Method of measurement: Review of MRI images. Shahid Beheshti University of Medical Sciences Approved 2025-01-12 Ethics Committee of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Scie Shahid Chamran Highway, Yemen Street, Shahid Arabi Street Tehran Tehran Iran (Islamic Republic of)