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Brief Title: APN401 in Treating Patients With Recurrent or Metastatic Pancreatic Cancer, Colorectal Cancer, or Other Solid Tumors That Cannot Be Removed by Surgery
Official Title: Safety and Immunologic Activity of Multiple Infusions of APN401
Study ID: NCT03087591
Brief Summary: This phase I trial studies the side effects and best dose of APN401 in treating patients with pancreatic cancer, colorectal cancer, or other solid tumors that have spread to other places in the body or have come back. APN401 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the toxicities and establish the safety of multiple infusions of small interfering ribonucleic acid (siRNA)-transfected peripheral blood mononuclear cells APN401 (APN401). SECONDARY OBJECTIVES: I. To determine the immunologic effects of multiple infusions of APN401. II. To document clinical response and survival. OUTLINE: Patients receive siRNA-transfected peripheral blood mononuclear cells APN401 intravenously (IV) over 30 minutes on days 1, 29, and 57 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Comprehensive Cancer Center of Wake Forest University, Winston-Salem, North Carolina, United States
Name: Pierre Triozzi
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR