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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 glioma will :
Using the data obtained during the follow-up period, researchers will conduct statistical analyses and evaluate the safety and efficacy of oncolytic virus TS-2021.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TS-2021 | Experimental | 30 eligible participants with recurrent malignant glioma will be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-2021 | Biological | The participants meeting the criteria will undergo TS-2021 oncolytic virus (5×1011PFU/ml) intratumoral injection using stereotactic technique under MR Localization. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events. | All events with a Grade 3 or above toxicity (defined by the CTCAE v4.0) will be tabulated by event and by relationship to TS-2021. | Up to 8 weeks |
| Overall survival | The overall survival for each patient receiving TS-2021 will be calculated. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) determined by MRI scan review. | Interval tumor size change will be measured. | Up to 12 months |
| Progression Free Survival. | Time after TS-2021 administration to clinical and radiographic disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fusheng Liu, MD,PhD | Contact | 861059975630 | liufushengs@hotmail.com | |
| Junwen Zhang, PhD | Contact | 861059975630 | jewzhang@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fusheng Liu, MD,PhD | Beijing Tiantan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| D000257 | Adenoviridae Infections |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| Up to 12 months |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |