Twenty to forty patients with advanced pancreatic cancer and sarcoma will receive DeltaRex-G intravenously at a dose of 3 x 10e11 colony forming units (cfu) or equivalent 1.6 x 10e10 Neo Units per dose three times a week for 3 weeks followed by one week rest. Based on previous Phase 1/2 US based clinical studies, DeltaRex-G does not suppress the bone marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further, tumor stabilization/regression/remission may occur later during the treatment period. Therefore, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.~If the patient develops a treatment-related >Grade 3 adverse event, the DeltaRex-G infusions will be held and the patient will be monitored until the toxicity has resolved to <Grade 1, and the patient is stable, after which treatment may be resumed. If the adverse event does not resolve to <Grade 1 within 3 weeks, the DeltaRex-G treatment will be held until the data are discussed with the Food and Drug Administration and a decision is made whether to continue or terminate the study.
Twenty to forty patients will receive DeltaRex-G intravenously at a dose of 3 x 10e11 colony forming units (cfu) or equivalent 1.6 x 10e10 Neo Units per dose three times a week for 3 weeks followed by one week rest. Based on previous Phase 1/2 US based clinical studies, DeltaRex-G does not suppress the bone marrow or cause serious organ dysfunction, and enhanced immune cell trafficking in tumors may cause the tumors to appear larger or new lesions to appear on CT, PET or MRI. Further, tumor stabilization/regression/remission may occur later during the treatment period. Therefore, DeltaRex-G will be continued regardless of CT, PET or MRI results if the patient has clinical benefit and does not have symptomatic disease progression.