DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With High-risk Soft Tissue Sarcoma
This trial is active, not recruiting.
|Condition||high-risk soft tissue sarcoma|
|Treatment||adenovirus-transfected dc + cik|
|Phase||phase 1/phase 2|
|Sponsor||Affiliated Hospital to Academy of Military Medical Sciences|
|Start date||June 2013|
|End date||December 2016|
|Trial size||30 participants|
|Trial identifier||NCT01898663, 307-CTC-DC/CIK|
The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with high-risk soft tissue sarcoma. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our previously performed preclinical study with DCs vaccine combined with CIK cells, the investigators plan to perform the clinical trial.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Adenovirus-transfected autologous DCs + CIK cells
Objective tumor response (CR+PR) as measured by RECIST criteria
time frame: 4 weeks after DC/CIK treatment
Number of participants with adverse events
time frame: 3 days within DC/CIK treatment
Male or female participants at least 18 years old.
Inclusion Criteria: - Intermediate or high grade sarcoma as determined by pathology review - Histopathologically confirmed diagnosis of intermediate or high grade sarcoma - Age≥18 years at time of consent - KPS(Karnofsky Performance Scale) ≥70 - Patient's written informed consent - No steroid therapy within 4 weeks of first DC vaccination - Stable disease, complete response and partial response(WHO, RECIST) - Predicted survival≥3 months - Normal liver, kidney and marrow function: WBC≥3.5×109/L、PLT≥90×109/L and Hb≥90g/L; blood Cr≤1.5×UNL (upper normal limit) and blood BIL≤1.5×UNL; ALT、AST≤1.5×UNL and ALT/AST≤5.0×UNL Exclusion Criteria: - Serious dysfunction of vital organs(heart, liver or kidney) - Received organ transplantation - Patients with other malignancies or brain metastases - History of autoimmune diseases - Pregnant and breast-feeding patient - Active or chronic infectious diseases - History of allergy or hypersensitivity to study product excipients - Currently participating in another clinical trial - Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks - Unfit for participating in this clinical trial in investigators' opinions
|Official title||Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With High-risk Soft Tissue Sarcoma: a Phase Ⅰ/Ⅱ Study|
|Principal investigator||Chen Hu, M.D., Ph.D.|
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