NCT00109941已完成2 期
Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor (OGF): Phase II
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Survival
研究概览
简要总结
RATIONALE: Opioid growth factor may stop the growth of pancreatic cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well opioid growth factor works in treating patients with advanced pancreatic cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the growth inhibitory effects of opioid growth factor ([Met^5]-enkephalin) in patients with advanced unresectable pancreatic cancer.
Secondary
- Determine the pharmacokinetics of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
- Determine the pain control, depression, and nutritional status of patients treated with this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
metenkephalin, OGF-opioid growth factor
Experimental
DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes
干预措施: opioid growth factor (Biological)
metenkephalin, OGF-opioid growth factor
Experimental
DRUG All subjects treated with met-enkephalin (also called OGF) 250 ug/kg iv weekly over 45 minutes
干预措施: metenkephalin, OGF-opioid growth factor (Biological)
结局指标
主要结局
Survival
次要结局
- Response (progressive disease, stable disease, partial response, complete response)
- Tumor size
- Quality of life
- Depression
- Opioid growth factor markers
研究者
研究点 (2)
Loading locations...
相似试验
终止
1 期
Opioid Growth Factor (OGF) and Gemcitabine: Novel Treatment for Pancreatic CancerPancreatic CancerNCT00783172Milton S. Hershey Medical Center4
已完成
2 期
Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic CancerPancreatic CancerNCT03983057Zhejiang University392
招募中
2 期
Preoperative mFOLFIRINOX (or Gem-Nab-P) +/- Isotoxic High-dose SBRT for Borderline Resectable Pancreatic AdenocarcinomaPancreatic AdenocarcinomaBorderline Resectable Pancreatic AdenocarcinomaPancreatic NeoplasmNCT05083247Erasme University Hospital256
已完成
不适用
Precision Medicine Guided Treatment for Cancer PainPainCYP2D6 PolymorphismNCT02664350University of Florida63
招募中
1 期
Chemotherapy for advanced pancreatic cancer with combined usage of gemcitabine and GSK3beta-inhibiting medicinesadvanced pancreatic cancerJPRN-UMIN0000050951)Multidisciplinary Cancer Center,Kanazawa Medical University Hospital 2)Department of Surgical Oncology, Kanazawa Medical University Hospital6