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| Name | Class |
|---|---|
| Ajou University School of Medicine | OTHER |
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This is a phase I trial evaluating the maximum tolerated dose, safety and efficiency of Mesenchymal stem cells into which the suicide gene, cytosine deaminase (CD), injected into the resection cavity of patients with recurrent glioblastoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The investigational drug into the Intratumoral administration | Other | The investigational drug in the amount of 1x10^7, 3x10^7cells per dose into the tumor or the tumor removal site using a syringe during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC11FCD | Drug | Administration period: Single dose Route of administration: Intratumoral administration Dose: 1x10^7, 3x10^7cells/dose Summary: Administer the investigational drug in the amount of 1x107, 3x107cells per dose into the tumor or the tumor removal site using a syringe during surgery. Concomitant drug: 5-Flucytosine (prodrug) Dose: 150mg/kg/day Directions: Administration period and directions: Administer 150m of 5-Flucytosine per kilogram of body weight every 6 hours for a total of 4 times a day (QID) for a duration of 7 days after surgery. Route of administration: Oral administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | Assessment of the maximum tolerated dose based on the 3+3 method
| after treatment discontinuation for approximately 1 years |
| Number Of Adverse Events related to the treatment | Evaluate the number of adverse event related to the treatment according to CTCAE V4.0 during the trial (including clinically significant changes in physical examination, radiographic images, safety lab tests, vital signs) | Baseline, Day0, 1 month, 3 months, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival improvement (OS) | OS is defined as the time from the date of MSC injection to the date of death due to any cause. | Study entry through the end of the study, up to 12 months |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyunggi Cho, MD,PhD | CHA University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang CHA Medical Center | Seongnam | Kyunggido | 13496 | South Korea |
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The progress-free survival analysis shall be based on the RANO criteria.
| Study entry through the end of the study, up to 12 months |
| Tumor assessment in regard to the investigational drug based on the RANO criteria | Assess the treatment groups participating in this clinical trial based on the RANO criteria. Compare and present the disease control rates by calculating the ratio of the number of subjects responding to treatment (complete response: CR, partial response: PR, stable disease: SD) among the treatment groups and control group assessed based on the RANO criteria. | At Baseline, 1month, 3months, 6months, 12months |
| Clinical efficacy assessment | Karnofsky performance status (KPS) assessment | At Baseline, 1month, 3months, 6months, 12months |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D001932 | Brain Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D043525 | Cytosine Deaminase |
| ID | Term |
|---|---|
| D009700 | Nucleoside Deaminases |
| D000619 | Aminohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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