Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hangzhou Medical Biotechnology Co., Ltd | UNKNOWN |
| CyTIX.Inc | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients after resection of glioblastoma.
This clinical trail includes two phases: basic treatment phase and immunotherapy phase. In basic treatment phase, patients will receive concomitant radiation and TMZ-chemotherapy. In immunotherapy phase, besides maintenance chemotherapy with TMZ, Fusion cells will be administered with IL-12 to enhance the immunity of patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Evaluation Group | Experimental | Basic treatment phase: The patients have surgery followed by concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days). Immunotherapy phase: Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. Fusion cells will be suspended in 0.5 mL normal saline and then injected intradermally close to a cervical lymph node. IL-12 will be injected subcutaneously at the same side at dose of 6ug twice for interval of one hour. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendritic Cell/Tumor Fusion Vaccine | Biological | Vaccine is derived from the participants dendritic cells and tumor cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) / Serious Adverse Events (SAE) | AE/SAE associated with the intervention will be captured throughout the treatment portion of the study. All adverse events will be then compiled and these patients will be recorded. | 2-3 years |
| Progression free survival (PFS) at 6 months | Assessed from this study start date to the date of the first observation of clinical or radiographic disease progression or death due to any cause. Patients will be censored at the time they are last known to be alive and progression free (if withdrawn or lost to follow-up). | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological Assays | Assays including Flow Cytometry and Elispot will be employed to determine if cellular and humoral immunity were induced by serial vaccination with DC/Tumor Fusion Cells and IL-12. | 2-3 years |
| Overall survival (OS) time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Shen, MD | Contact | 8613805730380 | sh_2nd@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Shen, MD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310051 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Interleukin-12 | Drug | Given subcutaneously at dose of 6ug twice for interval of one hour. |
|
|
| Temozolomide | Drug | Following concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days) , maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. |
|
|
Assessed from this study start date to date of death of any cause. Patients will be censored at the time that they are last known to be alive (if withdrawn or lost to follow-up).
| From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months |
| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310051 | China |
|
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
Not provided
Not provided
| ID | Term |
|---|---|
| D018664 | Interleukin-12 |
| D000077204 | Temozolomide |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided