This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study hypothesizes that administration of OGF will alter cancerous growth in human subjects with unresectable pancreatic cancer by acting as an inhibitory agent. We propose to investigate this hypothesis by conducting an open labeled prospective Phase II clinical trial to study the efficacy of OGF in human subjects with unresectable pancreatic cancer. The following specific aims are proposed: 1) Evaluate the growth inhibitory effects of OGF by treating patients with unresectable pancreatic cancer who have failed prior chemotherapy in a prospective study. Patients will receive OGF intravenously in a dose regime determined from the Phase I study. Efficacy will be examined by following patient survival, tumor response with CT scanning, and time until progression. 2) Study the pharmacokinetics of OGF when given chronically by examining blood OGF levels before and during the infusions. 3) Elucidate the effects of OGF on the quality of life, pain control, and depression in patients with pancreatic cancer by obtaining monthly surveys. The long-term objective of our research team is to understand the role of peptide growth factors in pancreatic cancer. This Phase II trial will be useful in determining the efficacy of OGF on cancer growth and quality of life in patients with unresectable pancreatic cancer. Our study employs the use of biotherapy with a novel naturally occurring opioid peptide which has been shown to inhibit growth of pancreatic cancer in preclinical studies and information accumulated in our Phase I clinical trial. This Phase II study will represent an extension of our basic science research discoveries translated into clinical practice.

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
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National Center for Research Resources Initial Review Group (RIRG)
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Pennsylvania State University
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