TREATMENT OF ADVANCED PANCREATIC CANCER WITH OPIOID GROWTH FACTOR PHASE II

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 中心，不一定是研究者的机构。 本研究假设OGF的给药将通过作为抑制剂改变患有不可切除的胰腺癌的人类受试者的癌生长。 我们建议通过进行一项开放标签的前瞻性II期临床试验来研究这一假设，以研究OGF对患有不可切除的胰腺癌的人类受试者的疗效。 建议的具体目标如下： 1)在一项前瞻性研究中，通过治疗既往化疗失败的不可切除胰腺癌患者来评估OGF的生长抑制作用。 患者将以I期研究确定的剂量方案静脉内接受OGF。 将通过随访患者生存期、CT扫描的肿瘤缓解和至进展的时间来检查疗效。 2)通过检查输注前和输注期间的血液OGF水平，研究OGF长期给药时的药代动力学。 3)通过每月一次的调查，阐明OGF对胰腺癌患者生活质量、疼痛控制和抑郁的影响。 我们研究小组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疗效。我们的研究采用了一种新型天然阿片肽的生物疗法，该肽在临床前研究和I期临床试验中积累的信息中已被证明可以抑制胰腺癌的生长。 这项II期研究将代表我们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.