Phase I Study Of Hepatic Arterial Infusion Of Nab-Paclitaxel (Abraxane®) In Patients With Metastatic Melanoma In The Liver
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Nab-Paclitaxel
研究概览
简要总结
The goal of this clinical research is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given directly to the area where the cancer is located. The safety of this drug will also be studied.
详细描述
The Study Drug:
Nab-paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Study Drug Groups:
If you are found to be eligible to take part in this study, you will be assigned to a dose level of nab-paclitaxel based on when you joined this study. Up to 4 dose levels of nab-paclitaxel will be tested. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of nab-paclitaxel is found.
Study Drug Administration:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have histologic confirmation of malignant melanoma, and documented metastatic disease.
- •Patients must have at least one clearly measurable metastatic lesion in the liver that is more than 2cm in the largest dimension. Indicator lesions at least 2cm are chosen primarily to have changes in tumor measurement more accurately reflective of effect of therapy, or lack of it.
- •Patients must not have received prior systemic chemotherapy with regimens including taxanes. Prior adjuvant treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression in the liver.
- •At least 4 weeks (28 days) since any prior immunotherapy, cytokine, biologic, vaccine therapy or tumor embolization in the liver and patients should have progressed during therapy. Patient must have recovered from any side effects before starting therapy on this protocol.
- •At least 4 weeks (28 days) since prior radiotherapy (if radiation therapy field covering > 20% of the bone marrow containing skeletal structures) and prior adjuvant therapy. Patient must have recovered from any side effects before starting therapy on this protocol.
- •Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.
- •Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 -
- •Patients must be >/= 18 years of age. The safety of NAB-Paclitaxel has not been studied in younger patients.
- •Patients must have normal serum total bilirubin level, transaminase levels (i.e., ALT and AST) no higher than 2.5 times the institution's upper normal limits. Patients must have adequate renal function: creatinine </= 1.5 mg/dL Patients must have adequate bone marrow function as defined by an absolute neutrophil count >/= 1,500/mm^3, platelet count >/= 100,000/mm^3 and hemoglobin >/= 9.0g/dL.
- •Life expectancy of at least 3 months.
- •Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.
排除标准
- •Patients who have received prior systemic chemotherapy with regimens including taxanes.
- •Patients with history of central nervous system (CNS) metastasis prior to registering to this study.
- •Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential. Patients may not breast-feed while on this study.
- •Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).
- •Patients with current peripheral neuropathy of any etiology that is greater than grade one.
- •Patients with unstable or serious concurrent medical conditions are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
- •Patients must not have had major surgery including node dissection, resection of melanoma metastatic to an organ or other surgical procedures that require hospitalization and administration of general anesthesia within the past 14 days.
- •Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.
- •Known HIV disease or infection.
- •Patients with ascites are not eligible.
研究组 & 干预措施
Nab-paclitaxel (Abraxane)
Day 1 of Cycles 1-6, Starting Dose of 130 mg/m2 received through arterial catheter over 30 minutes. Cycle is 21 Days.
Day 1 of Cycle 7+, Dose received through catheter in vein over 30 minutes. Cycle is 21 Days.
干预措施: Nab-Paclitaxel (Abraxane) (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Nab-Paclitaxel
时间窗: 6 weeks
The MTD of nab-paclitaxel in participants with metastatic melanoma, previously untreated with systemic chemotherapy, defined as the dose level prior to that resulting in dose limiting toxicity (DLT) (ie., the highest dose level of nab-paclitaxel at which 0 out of 3 patients or 1 out of 6 patients experience DLT).
次要结局
- Survival Rate(After 3, 21 day cycles)