A clinical trial to evaluate the effects of vaccine in patients of Pancreatic cancer

INTERVENTION: Intervention1: DO‐013 (Allogenic Pancreatic Cancer Vaccine): Stage I: Intervention: DO‐013 (Allogenic Pancreatic Cancer Vaccine); 5 intradermal doses of DO‐013 are 0.1, 0.2 and 0.4 ml in dose‐escalating pattern every 14 days. Stage II: Intervention: 5 intradermal doses of OBD of DO‐013 (as determined from stage‐I) every 14 days. Control Intervention1: Gemcitabine IV infusion: Stage II: A dose of 1000 mg/m2 over 30 minutes once weekly for up to 7 weeks, followed by a week of rest from treatment. CONDITION: Advanced Carcinoma of Pancreas PRIMARY OUTCOME: Stage I: ; Safety and tolerability of DO‐013 to estimate minimal toxicity profile of a dose(28 days post first vaccination) ; Stage II: ; Overall safety and tolerability analysis for DO‐013 alone (test‐arm‐1) in ; comparison to DO‐013 plus gemcitabine (test‐arm‐2) [Time frame: 0‐112 ; days] ; ‐‐‐‐‐‐Timepoint: Stage I: ; Safety and tolerability of DO‐013 to estimate minimal toxicity profile of a dose(28 days post first vaccination) ; Stage II: ; Overall safety and tolerability analysis for DO‐013 alone (test‐arm‐1) in ; comparison to DO‐013 plus gemcitabine (test‐arm‐2) [Time frame: 0‐112 ; days] ; SECONDARY OUTCOME: Stage I: ; Overall safety and tolerability analysis ; Stage II: ; Tumor markers of test‐arm‐1 versus test‐arm‐2 ; OS of test‐arm‐1 versus test‐arm‐2 ; PFS of test‐arm‐1 versus test‐arm‐2 ; Tumor response versus test‐arm‐2 ; CBR of test‐arm‐1 versus test‐arm‐2‐‐‐‐‐‐Timepoint: Stage I: ; Time frame: 0‐112 days ; Stage II: ; Tumor markers‐Time frame: Baseline, and ; at 57th and 113th day post first vaccination dose ; OS‐Time frame: Every 4‐week till death ; PFS‐Time frame: Every 8‐week till disease ; progression or death ; Tumor response‐Time frame: Every 8‐week till disease progression or ; death ; CBR‐0‐ ; 112 days INCLUSION CRITERIA: â?¢ Histologically or cytologically confirmed malignancy of exocrine pancreas with evidence of locally advanced (non‐resectable stage‐ II or III) ormetastatic disease (stage‐IV), with following criteria: a) Stage‐I and stage‐II (test‐arm‐1): Patients who have been refractory to standard chemotherapy (including gemcitabine‐based regimens) or any other therapy or for whom no standard therapy exists. b. Stage‐II (test‐arm‐2): Patients who may have received previous chemotherapy or radiation therapy, but must be amenable for a gemcitabine treatment according to the discretion of investigator. â?¢ Male and female patients with the age of 18 years or above. â?¢ Life expectancy of at least 12 weeks â?¢ Eastern Cooperative Oncology Group (ECOG) performance status: â?¤2 â?¢ Patient with at least one uni‐dimensionally measurable lesion by computed â?¢ tomography (CT) scan as defined by Response Evaluation C