Status:
RECRUITING
Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma
Lead Sponsor:
Beijing Neurosurgical Institute
Conditions:
Glioblastoma Multiforme
Glioma, Malignant
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to evaluate the safety and efficacy of oncolytic virus TS-2021 in the treatment of recurrent malignant glioma.About 30 eligible participants with recurrent malignant...
Eligibility Criteria
Inclusion
- The patient signed the informed consent voluntarily.
- Age ≥18 years and ≤65 years, male or female.
- After the initial surgery, the imaging showed that the tumor was completely removed, followed by conventional radiotherapy or (and) chemotherapy, and no recurrence was observed within two months after the end of radiotherapy. The patient had a recurrence of supratentorial high-grade glioma. The pathological diagnosis was glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendro-astrocytoma, or subtentorial astrocytoma recurrence.
- After conventional surgery, radiotherapy (or) chemotherapy was performed, and there was no recurrence at the primary site of the tumor, but there was tumor recurrence at the distant site.
- With PET/MRS, tumor recurrence was considered, and the enhanced lesion diameter was greater than 1cm, but less than 3cm.
- KPS score ≥70 before treatment.
- Normal bone marrow reserve function and normal liver and kidney function: Neutrophil absolute value ≥ 1,500/mm3, hemoglobin ≥10 g/dL, platelet count ≥100,000/mm3, total bilirubin level ≤1.5×ULN, glutamic pyruvic transaminase/glutamic oxalacetic transaminase ≤ 2.5× ULN, serum creatinine ≤1.5×ULN, The heart function was normal and the follow-up compliance was good.
- Women of childbearing age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure that they do not become pregnant during the study period and for 3 months after stopping treatment.
Exclusion
- Pregnant or lactating patients.
- Patients with encephalitis disease, multiple sclerosis, or other CNS (Central Nervous System) infection.
- Patients with a history of organ transplantation or waiting for organ transplantation.
- Patients with uncontrolled infectious diseases or other serious diseases, such as HIV positive.
- Patients with any unstable systemic illness (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 12 months before enrollment, severe arrhythmia requiring medical treatment, liver or kidney failure, etc.)
- Patients with systemic autoimmune diseases or immunodeficiency diseases.
- Patients with severe allergic constitution.
- Patients with chronic diseases requiring long-term treatment with immune agents or glucocorticoids.
- Patients with mental disorders.
Key Trial Info
Start Date :
August 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06585527
Start Date
August 29 2024
End Date
January 1 2026
Last Update
October 31 2024
Active Locations (1)
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1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China, 100050