The study is a prospective single armed, open label phase I study. Patients with advanced or metastatic GIST and tumor progression despite ongoing treatment with second, third or fourth line TKI treatment, and with at least one measureable tumor lesion, will be eligible for the study. A maximum of 12 patients will be included in this study. The patients will continue with TKI treatment until the 3 months follow up visit. If further tumor progression TKI will be withdrawn but if stable disease or objective response the patient will continue with TKI until progress. The investigational product Intuvax will be injected into a tumor lesion at two or three treatment occasions; day 1, 14 days (±3 days) after the first vaccination, and 28 days (±3 days) after the second vaccination (patient 7-12 only). Intuvax will be injected in a viable part of the tumor, using ultrasound-guided or CT technique for correct administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Therapeutic vaccine: allogeneic, proinflammatory dendritic cells, suspension for intratumoral injection
Department of Breast and Endocrine Surgery, Section of Endocrine and Sarcoma Surgery, Karolinska University Hospital
Stockholm, Sweden
Changes in vital signs (heart rate, blood pressure, body temperature)
Time frame: Up to 12 months after vaccination 1
Changes in lab parameters (hematology and biochemistry) during the study versus baseline
Time frame: Up to 12 months after vaccination 1
Adverse events according to CTCAE v 4.03
Time frame: Up to 12 months after vaccination 1
Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to mRECIST
Criteria based on the diameter of the contrast-enhanced portions of the tumor
Time frame: Every 3 months up to 12 months after vaccination 1
Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to RECIST 1.1.
Criteria based on the maximal tumor diameter
Time frame: Every 3 months up to 12 months after vaccination 1
Tumor response by determining changes (PD, SD, PR, CR) in tumor diameter according to Choi criteria
Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.
Time frame: Every 3 months up to 12 months after vaccination 1
Progression free survival according to mRECIST
Criteria based on the diameter of the contrast-enhanced portions of the tumor
Time frame: Up to 12 months after vaccination 1
Progression free survival according to RECIST 1.1
Criteria based on the maximal tumor diameter
Time frame: Up to 12 months after vaccination 1
Progression free survival according to Choi criteria
Criteria based on unidimensional tumor size and tumor density on contrast-enhanced CT images.
Time frame: Up to 12 months after vaccination 1
Changes in WHO-ECOG score
Time frame: Up to 12 months after vaccination 1
Levels of autoimmunization parameters
Screening of autoantibodies against nuclear antigens (ANA), including the nuclear antigens SSA, SSB, Sm, RNP, Scl-70, Centromeres and Jo-1
Time frame: Up to 3 months after vaccination 1
Levels of alloimmunization parameters
Screening of alloantibodies against HLA-A, B, C (MHC-class I) and HLA-DR (MHC-class II) antigens
Time frame: Up to 3 months after vaccination 1
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