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Phase I Trial with Expansion Cohort of Obp-301 (Telomelysintm) And Definitive Chemoradiation For Patients with Locally Advanced Esophageal And Gastroesophageal Adenocarcinoma Who Are Not Candidates For Surgery
This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tumor cells (although there is a small risk that it can also infect normal cells). Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving OBP-301 with chemotherapy and radiation therapy may work better than standard chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal cancer.
Primary Objective To determine if the addition of OBP-301 to chemoradiation with carboplatin/paclitaxel is safe. Secondary Objectives 1.2.1 To assess toxicities associated with the addition of OBP-301 to chemoradiation. 1.2.2 To assess the number of clinical complete responses (cCR). 1.2.3 To assess the number of patients alive/without progression (PFS) and the number of patients alive (OS) at 1 and 2 years.
Chemotherapy (NOS); Radiotherapy; Therapy (NOS)
OBP-301 (); Paraplatin (carboplatin); Taxol (paclitaxel); carboplatin (); paclitaxel ()
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