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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
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RATIONALE: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This trial is studying the safety and effectiveness of autologous gp96 treatment of glioblastoma and to see how well it works in treating patients with newly diagnosed supratentoria glioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gp96 group | Experimental | autologous gp96 vaccination + basal treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gp96 | Biological | vaccination of autologous gp96 derived from tumor tissue + basal treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| blood count | blood count within 3 days before first vaccination | baseline |
| blood count | blood count within 3 days after the second injection | within 3 days after the second injection |
| blood count | blood count within 3 days after the 6th injection | within 3 days after the 6th injection |
| blood chemistries | blood chemistries test within 3 days before first vaccination | baseline |
| blood chemistries | blood chemistries test within 3 days after the second injection | within 3 days after the second injection |
| blood chemistries | blood chemistries test within 3 days after the 6th injection | within 3 days after the 6th injection |
| electrocardiogram | electrocardiogram test within 3 days before first vaccination | baseline |
| electrocardiogram | electrocardiogram test within 3 days after the second injection | within 3 days after the second injection |
| Measure | Description | Time Frame |
|---|---|---|
| tumor control rate | tumor control rate at 6th month after surgery | six month after surgery |
| progress free survive | up to 3 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhixian Gao, Doctor | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital Affiliated to Capital Medical University | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29769450 | Derived | Ji N, Zhang Y, Liu Y, Xie J, Wang Y, Hao S, Gao Z. Heat shock protein peptide complex-96 vaccination for newly diagnosed glioblastoma: a phase I, single-arm trial. JCI Insight. 2018 May 17;3(10):e99145. doi: 10.1172/jci.insight.99145. eCollection 2018 May 17. |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C018551 | glucose-regulated proteins |
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| electrocardiogram | electrocardiogram test within 3 days after the 6th injection | within 3 days after the 6th injection |
| progression-free survival rate of six month | progression-free survival rate of six month | six month after surgery |
| overall survive |
| up to 3 years |
| quality of life | up to 3 years |
| changes in antigen specific T cells | tumor antigen specific T cells was determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen. | baseline and within 3 days before the 6th injection |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |