High-risk Soft Tissue Sarcoma Clinical Trial
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
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.
| Status | Active, not recruiting |
| Enrollment | 30 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Hematopoietic Stem Cell Transplantation | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Affiliated Hospital to Academy of Military Medical Sciences |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective tumor response (CR+PR) as measured by RECIST criteria | 4 weeks after DC/CIK treatment | No | |
| Secondary | Number of participants with adverse events | 3 days within DC/CIK treatment | Yes |