OGF & Gemcitabine: A Novel Treatment for Pancreatic Cancer: Phase I Study

有机生长因子

基本信息

  • 批准号:
    7589518
  • 负责人:
  • 金额:
    $ 7.71万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2008
  • 资助国家:
    美国
  • 起止时间:
    2008-09-17 至 2010-08-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): Pancreatic cancer is the 4th leading cause of cancer-related deaths in the United States with a median survival of 3-6 months and a five-year survival rate of 1% making it the worse of all gastrointestinal malignancies. The reason for the poor prognosis is related to failure to diagnose this cancer in early stages and the unresponsiveness of pancreatic cancer to conventional chemotherapy and radiation therapy. Gemcitabine has become the standard of care in treatment of advanced pancreatic cancer; however, the mean survival with gemcitabine is reported at only 5.6 months. Our research team has discovered a novel biotherapy called Opioid Growth Factor (OGF) that inhibits growth of pancreatic cancer in vitro, in animals, and in human subjects. A Phase 1 study with OGF has been completed and the maximum tolerated dose, safety and toxicity evaluated. Currently a Phase 2 trial is in progress to study the efficacy of OGF monotherapy in those who have not responded to standard treatment. Recent experiments from our basic science laboratories indicate a marked additive benefit in cancer inhibition when OGF is combined with gemcitabine. Additionally, animals receiving the combination regime were healthier than those treated with gemcitabine alone suggesting perhaps a protective effect of OGF to chemotherapy toxicity. It is hypothesized that OGF may be safely administered in combination with gemcitabine to individuals with unresectable pancreatic cancer. In order to test this hypothesis 22 eligible na¿ve patients with pancreatic cancer will be prospectively treated with standard doses of gemcitabine. Concomitantly, OGF will be administered weekly starting at 150 ?g/kg and increasing to the Maximum tolerated dose of 250 ?g/kg in order to determine the following specific aims: 1) evaluate the safety and toxicity of the combination of OGF biotherapy and gemcitabine; 2) determine whether the combination therapy alters the pharmakokinetics of either agent; and 3) study the efficacy of combination therapy on tumor size, patient survival, and time to progression of disease. The long-term goal of our research team involves translation of novel discoveries from the basic science laboratory into clinical practice with the ultimate goal of improving survival of patients with this devastating disease. PUBLIC HEALTH RELEVANCE: In this proposal the safety and efficacy of a new natural biotherapy called OGF will be tested with standard chemotherapy, gemcitabine, in untreated patients with pancreatic cancer not amenable to surgery. OGF is a new agent discovered to inhibit growth of pancreatic cancer and research shows possibly better results when given with gemcitabine. Infusions will be given by the vein weekly and blood tests and CT scans followed for safety and response.
描述(由申请人提供):胰腺癌是美国癌症相关死亡的第四大原因,中位生存期为3-6个月,5年生存率为1%,是所有胃肠道恶性肿瘤中最严重的。预后不良的原因与未能在早期诊断这种癌症以及胰腺癌对常规化疗和放疗无反应有关。吉西他滨已成为治疗晚期胰腺癌的标准治疗;然而,吉西他滨的平均生存期仅为5.6个月。我们的研究团队发现了一种名为阿片样生长因子(OGF)的新型生物疗法,可在体外,动物和人类受试者中抑制胰腺癌的生长。已经完成了OGF的I期研究,并评估了最大耐受剂量、安全性和毒性。目前正在进行一项2期试验,以研究OGF单药治疗对标准治疗无反应的患者的疗效。我们基础科学实验室的最新实验表明,当OGF与吉西他滨联合使用时,在癌症抑制方面具有显著的附加益处。此外,接受联合方案的动物比单独用吉西他滨治疗的动物更健康,这可能表明OGF对化疗毒性的保护作用。据推测,OGF可以安全地与吉西他滨联合施用于患有不可切除的胰腺癌的个体。为了检验这一假设,将对22例合格的胰腺癌初治患者进行标准剂量吉西他滨的前瞻性治疗。同时,OGF将每周给药一次,从150?g/kg,并增加至最大耐受剂量250?为了确定以下具体目的,使用0 GF生物疗法和吉西他滨的组合来进行治疗:1)评估0 GF生物疗法和吉西他滨的组合的安全性和毒性; 2)确定组合疗法是否改变任一药剂的药理学;和3)研究组合疗法对肿瘤大小、患者存活和疾病进展时间的功效。我们研究团队的长期目标是将基础科学实验室的新发现转化为临床实践,最终目标是提高这种毁灭性疾病患者的生存率。公共卫生关系:在这项提案中,一种名为OGF的新天然生物疗法的安全性和有效性将与标准化疗吉西他滨一起在未经治疗的胰腺癌患者中进行测试,这些患者不适合手术。OGF是一种新发现的抑制胰腺癌生长的药物,研究表明与吉西他滨联合使用可能会有更好的效果。每周通过静脉输注,随后进行血液检查和CT扫描,以确定安全性和反应。

项目成果

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Jill P Smith其他文献

Jill P Smith的其他文献

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{{ truncateString('Jill P Smith', 18)}}的其他基金

Phase 1 study to test safety and dose of proglumide as an anti-fibrotic agent
第一阶段研究测试丙谷胺作为抗纤维化药物的安全性和剂量
  • 批准号:
    9808375
  • 财政年份:
    2019
  • 资助金额:
    $ 7.71万
  • 项目类别:
Phase 1 study to test safety and dose of proglumide as an anti-fibrotic agent
第一阶段研究测试丙谷胺作为抗纤维化药物的安全性和剂量
  • 批准号:
    10015244
  • 财政年份:
    2019
  • 资助金额:
    $ 7.71万
  • 项目类别:
High fat diet stimulates pancreatic cancer through the actions of Cholecystokinin
高脂肪饮食通过胆囊收缩素的作用刺激胰腺癌
  • 批准号:
    8969907
  • 财政年份:
    2015
  • 资助金额:
    $ 7.71万
  • 项目类别:
CLINICAL TRIAL: OGF & GEMCITABINE: NOVEL TREATMENT FOR PANCREATIC CANCER
临床试验:OGF
  • 批准号:
    7951267
  • 财政年份:
    2009
  • 资助金额:
    $ 7.71万
  • 项目类别:
THE EFFICACY OF LOW DOSE NALTREXONE THERAPY IN CHILDREN WITH CROHN'S
低剂量纳曲酮治疗克罗恩病儿童的疗效
  • 批准号:
    7951293
  • 财政年份:
    2009
  • 资助金额:
    $ 7.71万
  • 项目类别:
THE EFFECTS OF NALTREXONE ON ACTIVE CROHN'S DISEASE
纳曲酮对活动性克罗恩病的影响
  • 批准号:
    7951264
  • 财政年份:
    2009
  • 资助金额:
    $ 7.71万
  • 项目类别:
OGF & Gemcitabine: A Novel Treatment for Pancreatic Cancer: Phase I Study
有机生长因子
  • 批准号:
    7688483
  • 财政年份:
    2008
  • 资助金额:
    $ 7.71万
  • 项目类别:
The Cholecystokinin-C (CCK-C) Receptor for Early Detection of Pancreatic Cancer
用于早期检测胰腺癌的胆囊收缩素-C (CCK-C) 受体
  • 批准号:
    7498561
  • 财政年份:
    2007
  • 资助金额:
    $ 7.71万
  • 项目类别:
THE EFFECTS OF NALTREXONE ON ACTIVE CROHN'S DISEASE
纳曲酮对活动性克罗恩病的影响
  • 批准号:
    7625800
  • 财政年份:
    2007
  • 资助金额:
    $ 7.71万
  • 项目类别:
TREATMENT OF ADVANCED PANCREATIC CANCER WITH OPIOID GROWTH FACTOR PHASE II
使用阿片类生长因子 II 期治疗晚期胰腺癌
  • 批准号:
    7625739
  • 财政年份:
    2007
  • 资助金额:
    $ 7.71万
  • 项目类别:

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