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Placental or tumor-derived heat shock protein gp96 is collected, purified, and stored. The DC cells are isolated from the patient's blood and then cocultured with the gp96 to obtain the activated DC cell product. The manufactured DC cells are subcutaneously or intra-tumor injected into the patient. Clinical studies will be performed to test anti-cancer function of the DC vaccination for immunotherapy of cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the DC vaccine immunotherapy on advanced cancers will firstly be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placental gp96 induced DC cell Vaccine | Experimental |
| |
| Tumor-derived gp96 induced DC cell Vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC cell Vaccine | Biological | Deliver DC cell vaccine into patients for anti-ancer therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Dose Limiting Toxicity | A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients with best response as either complete remission or partial remission. | Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate. | Six months |
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Inclusion Criteria:
1. Patients with advanced cancer; 2. Life expectancy >12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenfeng Zhang, MD, PhD | Contact | 0086-020-39195965 | zhangzhf@gzhmu.edu.cn | |
| Bingjia He, MD | Contact | 0086-020-39195965 | 464677938@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenfeng Zhang, MD, PhD | Second Affiliated Hospital of Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guanzhou | Guangdong | 51260 | China |
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