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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| Shenzhen Second People's Hospital | OTHER |
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This trial is to further study the safety and effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
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.
Overall Goals:
- to evaluate the safety and induction of anti-tumor immunity by administration of an immunogenic human tumor cell vaccine, and assess immune response in relation to clinical outcome.
Primary Aim:
- to further evaluate effectiveness of autologous gp96 treatment of glioblastoma on the basis of preliminary work.
Secondary Aims:
to study the immune response to vaccination, to monitor clinical responses , to further the safety of vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gp96 group | Experimental | Patients receive standard treatment with radiation and temozolomide after surgery. Then 6 times of autologous gp96 vaccination are administered via subcutaneous injection in 25μg doses at the 2nd week after the end of postoperative radiotherapy. ( gp96 is administered once a week for the first 4 weeks, the 5th injection is administered 2 weeks after the 4th injection, and the 6th injection is administered 3 weeks after the 5th injection. ) The first adjunctive temozolomide startes on the day of the fifth gp96 injection. (150-200 mg/m2/day for 5 days, then stop for 23 days, one cycle is 28 days for a total of 6 cycles) |
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| control group | Active Comparator | Patients receive standard treatment with radiation and temozolomide after surgery. Then only adjuvant treatment with temozolomide is administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gp96 | Biological | 25 mcg IH |
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| Measure | Description | Time Frame |
|---|---|---|
| 1-year survival rate | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival rate | 1 year | |
| Progression-free survival | 5 years | |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhixian Gao, Doctor | Contact | 086-13810876745 | zhixian_g@hotmail.com |
| 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 | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| C018551 | glucose-regulated proteins |
| D018869 | Heat-Shock Response |
| C484813 | vitespin |
| D000077204 | Temozolomide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013312 | Stress, Physiological |
| D010829 | Physiological Phenomena |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
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| Temozolomide | Drug | temozolomide monotherapy (150-200 mg / m2 / day for 5 days, then discontinuance for 23 days , 28 days for a a cycle, a total of 6 cycles ). |
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| radiotherapy | Radiation | Stupp regimen of radiotherapy |
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| 5 years |
| changes in antigen specific T cells | tumor antigen specific T cells are determined by IFN-γ Enzyme-linked Tumor antigen specific T cells will be determined by IFN-γ Enzyme-linked immunosorbent spot using the autologous tumor cell lysis as the antigen. | within 3 days before the first vaccination and within 10 days after the last vaccination |
| Number of participants with adverse events related to gp96 immunotherapy | A complete blood count will be requested before the first vaccination, after the second vaccination and after the last vaccination to monitor the side effect of gp96 immunotherapy. And blood chemistries will also be requested at the same time point for the same reason.And other adverse events related to gp96 immunotherapy will be recorded according to the NCI-CTCAE 5.0 criteria. | up to 3 months after vaccine completion |
| D009930 |
| Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013812 | Therapeutics |