Immuno-embolization of Hepatic Artery With Granulocyte-macrophage Colony Stimulating Factor (GM-CSF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Response of Liver Metastases
研究概览
简要总结
Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization). It is hoped with this novel approach that:
- tumor cells will die due to a loss of their blood supply,
- local inflammatory reactions induced by GM-CSF will kill remaining tumor cells, and
- a systemic immune response against tumor cells may develop.
详细描述
Patients with uveal melanoma metastatic to the liver will be treated with embolization of the hepatic artery every 4 weeks. GM-CSF (granulocyte-macrophage colony simulating factor) or normal saline will be injected into one of the liver arteries with an oily contrast dye, Ethiodol. This is followed by blockage of the artery with small pieces of gelatin sponge (embolization).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic uveal melanoma in the liver with histological confirmation
- •Ability/willingness to give informed consent
- •ECOG performance status of 0 or 1
- •Adequate renal, liver and bone marrow function
排除标准
- •Solitary liver metastasis that is amenable to surgical removal
- •Presence of symptomatic liver failure including ascites and hepatic encephalopathy
- •Presence of extra-hepatic metastases
- •Untreated brain metastases
- •Uncontrolled hypertension or congestive heart failure or acute myocardial infarction within 6 months of entry
- •Presence of any other medical complication that imply survival of less than six months
- •Uncontrolled sever bleeding tendency or active GI bleeding
- •Significant allergic reaction to contrast dye or GM-CSF
- •Immunosuppressive treatments such as systemic steroids, radiation to pelvis or systemic chemotherapy within 4 weeks
- •Previous embolization of the hepatic artery or intrahepatic arterial chemotherapy of liver metastasis
- •Active hepatitis with serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) greater than 5 x normal
- •HIV infection positive by ELISA
- •Pregnancy or breast feeding women
- •Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
- •Significant arteriovenous shunt identified on angiography of the hepatic artery
- •Occlusion of main portal vein or inadequate collateral flow around an occluded portal vein
研究组 & 干预措施
Immunoembolization
Liver embolization treatment with injection of GM-CSF.
干预措施: GM-CSF (Drug)
Immunoembolization
Liver embolization treatment with injection of GM-CSF.
干预措施: Embolization (Procedure)
Plain embolization
Liver embolization with normal saline injected in place of GM-CSF
干预措施: Embolization (Procedure)
结局指标
主要结局
Response of Liver Metastases
时间窗: Every 8 weeks
Complete response: Disappearance of all target and non-target liver lesions Partial response: \>= 30% decrease in the sum of the longest diameters (LD) relative to baseline sum LD with at least stable non-target liver lesions Stable disease: Absence of change which would qualify as response or progression Progression: \>= 20% increase in the sum LD in target liver lesions or unequivocal progression of non-target liver lesions in the treated lobe(s) or appearance of one or more new liver lesions \>= 10mm in the treated lobe(s)
Overall Response Rate
时间窗: Baseline then 3 to 4 weeks after every 2 treatments
Clinical response in the liver metastases will be evaluated after every two embolizations using CT scans or MRI of the abdomen. The sum of the longest diameter (LD) of up to 6 target lesions will be used to determine response. Target indicator lesions will be identified and measured as baseline prior to the first embolization. The same target lesions will then be measured 3 to 4 weeks after every two treatments. The sum of the baseline LDs will be compared to the sum of the LDs after every two treatments.
次要结局
- Overall Survival(Baseline to death)
- Median Progression Free Survival(Baseline to time of progression)
- Systemic Progression Free Survival(Baseline to time of progression)