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The study protocol will be changed
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| Name | Class |
|---|---|
| Lytvin,Ruslan | UNKNOWN |
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The objective of this pilot study is to evaluate the efficacy of adding S-Gboxin to standard RT/TMZ treatment protocols in patients with glioblastoma multiforme (GBM) or midline glioma (DMG), regardless of their mutation status
This is a pilot study to evaluate the efficacy of adding the mitochondrial oxidative phosphorylation inhibitor S-Gboxin (OXPHOS) to standard treatment for glioblastoma multiforme or glioma.
Subjects will start oral S-gboxin orally twice daily and will evaluate the patients and vital status if they tolerate this dose at 3, 7and 15 days after initiation.
Patients will undergo MRI scans before treatment and then at multiple time points during their participation in this Clinical Trial to monitor early tumor response to treatment ( MRI dates will be scheduled by the clinical trial coordinator)
Peripheral blood samples will be collected at baseline, days 1-7-15-28-36-72 to compare biological indicators of treatment response. In some cases, circulating tumor cells (CTCs) will be monitored by real-time qRT-PCR to correlate with clinical data.
Patients will also be assessed for the side effects they experience. Disease-free and overall survival outcomes will be recorded.
Patients will also have their depressive symptoms, quality of life, and neurocognitive function assessed at multiple time points during and after treatment.
After completion of the study, patients will be followed up at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients will be offered 4 courses of Gboxin during (or without) standard treatment. | Experimental | Patients will be offered 4 courses of S-Gboxin during standard treatment. Each course (18 days) consists of twice daily intake of S-Gboxin for 14 days and four days of rest. Each dose of S-Gboxin is packed in a gelatin capsule with a bandage and applied markings. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-Gboxin | Biological | Gboxin specifically inhibits the growth of human glioblastoma cells but not normal cells. Gboxin rapidly and irreversibly impairs oxygen consumption in glioblastoma cells. Its positive charge for binding to mitochondrial oxidative phosphorylation complexes is dependent on the proton gradient of the inner mitochondrial membrane, and it inhibits F 0 F 1 ATP synthase activity in tumor cells. S-Gboxin crosses the blood-brain barrier at therapeutically effective concentrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Brain tumor metabolism as measured by PET and MRI | The standardized uptake value (SUV) of HGG will be measured. SUV is a standard PET measurement. MRI with contrast will evaluate the change in tumor size before and after therapy S-Gboxin | Up to 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Kaplan-Meier survival estimates for OS will be presented with using Greenwood's formula at 12 months. | Up to 12 month |
| Incidence of adverse events graded according to the Common Toxicity Criteria for Adverse Events (CTCAE) version (v)4.03 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tbilisi Cancer Centre | Tbilisi | 0198 | Georgia | |||
| Kazakh Institute of Oncology and Radiology |
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| Label | URL |
|---|---|
| Gboxin is an oxidative phosphorylation inhibitor that targets glioblastoma | View source |
| Cancer cell-mitochondria hybrid membrane coated Gboxin loaded nanomedicines for glioblastoma treatment | View source |
| Nanomedicine and Immunotherapy for recurrent glioblastoma |
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documents will be available 3 months after completion of the research
free access
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The data will be organized by major organ system and MedDRA severity after completion of the Clinical Study. |
| Up to 1 month after last dose of S-Gboxin |
| Almaty |
| 490 078 |
| Kazakhstan |
| National Cancer Institute | Kyiv | 33/43 | Ukraine |
| View source |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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