Squamous Cell Carcinoma Clinical Trial
Official title:
Phase I Trial With Expansion Cohort of OBP-301 (Telomelysin™) and Definitive Chemoradiation for Patients With Locally Advanced Esophageal and Gastroesophageal Cancer 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: I. To determine if the addition of OBP-301 to chemoradiation with carboplatin/paclitaxel is safe. SECONDARY OBJECTIVES: I. To assess toxicities associated with the addition of OBP-301 to chemoradiation. II. To assess the number of clinical complete responses (cCR). III. To assess the number of patients alive/without progression (progression-free survival [PFS]) and the number of patients alive (overall survival [OS]) at 1 and 2 years. EXPLORATORY OBJECTIVE: I. To report correlate outcomes - cCR, PFS and OS - with immune and virus-based correlative assays. OUTLINE: This study will evaluate an initial dose of OBP-301 and a de-escalated dose, if needed. Patients receive OBP-301 by intratumoral injection via endoscopy on days -3, 12, and 26. Patients also receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, and 29, and undergo radiation therapy on Monday through Friday beginning day 1 for 28 fractions over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 and 6-8 weeks, then every 3 months for 2 years. ;
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