TREATMENT OF ADVANCED PANCREATIC CANCER WITH OPIOID GROWTH FACTOR PHASE II

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这项研究假设，OGF 的施用将通过充当抑制剂来改变患有不可切除胰腺癌的人类受试者的癌症生长。 我们建议通过开展一项开放标记的前瞻性 II 期临床试验来研究这一假设，以研究 OGF 对患有不可切除胰腺癌的人类受试者的疗效。 提出以下具体目标： 1) 在一项前瞻性研究中，通过治疗先前化疗失败的不可切除的胰腺癌患者来评估 OGF 的生长抑制作用。 患者将按照 I 期研究确定的剂量方案静脉注射 OGF。 将通过跟踪患者生存情况、CT 扫描的肿瘤反应以及进展时间来检查疗效。 2) 通过在输注前和输注期间检查血液 OGF 水平来研究长期给予 OGF 的药代动力学。 3) 通过每月的调查来阐明 OGF 对胰腺癌患者的生活质量、疼痛控制和抑郁的影响。 我们研究团队的长期目标是了解肽生长因子在胰腺癌中的作用。这项 II 期试验将有助于确定 OGF 对不可切除的胰腺癌患者的癌症生长和生活质量的功效。我们的研究采用了一种新型天然阿片肽生物疗法，在临床前研究和我们的一期临床试验中积累的信息中，该肽已被证明可以抑制胰腺癌的生长。 这项二期研究将代表我们将基础科学研究发现转化为临床实践的延伸。

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.