TREATMENT OF ADVANCED PANCREATIC CANCER WITH OPIOID GROWTH FACTOR PHASE II

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究假设，OGF的使用将通过作为抑制剂来改变不能切除的胰腺癌受试者的肿瘤生长。我们建议通过进行一项开放标签的前瞻性II期临床试验来研究OGF对不能切除的胰腺癌患者的疗效，从而来研究这一假说。具体目的如下：1)通过前瞻性研究评价OGF对化疗失败的不能切除胰腺癌患者的生长抑制作用。患者将接受OGF静脉注射，剂量由第一阶段研究确定。疗效将通过观察患者的生存期、CT扫描的肿瘤反应和进展时间来检验。2)通过检测输注前和输注过程中血中OGF水平，研究长期给药时OGF的药代动力学。3)通过每月的问卷调查，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多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对不能切除的胰腺癌患者的肿瘤生长和生活质量的疗效。我们的研究使用了一种新的自然产生的阿片肽的生物治疗，这种阿片肽已经在临床前研究和我们的I期临床试验中积累的信息中被证明可以抑制胰腺癌的生长。这项第二阶段研究将代表着我们的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.