Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Primary Objective
研究概览
简要总结
High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above.
详细描述
The primary objectives of this phase II multicenter trial are to:
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population.
The secondary objectives are to:
Determine the freedom from progression (FFP). Measure the response rate (RR). Obtain immunological data from the use of this regimen in vivo (as separate project: Moffitt?).
The proposed study is a multicenter phase II trial of HD-IL-2 in combination with GM-CSF. GM-CSF will be started 7 days before day 1 of HD-IL-2 and will be continued for 4 weeks to day 28, encompassing two cycles of HD-IL2. The first 9 patients will be closely monitored for unexpected toxicity.
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
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of melanoma with measurable disease
- •Patients with stage IV or unresectable advanced melanoma
- •Age at least 16 years.
- •ECOG performance status of 0-1
- •Life expectancy > 3 months
- •Adequate major organ function to tolerate therapy, as defined by:
- •Total bilirubin 2.0 mg/dL.
- •Creatinine 1.8 mg/dL.
- •WBC 3,000/mm
- •Platelet count 100,000/mm
- •Patients 50 years of age with one or more cardiac risk factors must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation
- •Left ventricular ejection fraction > 40%
- •Women of childbearing age must agree to use barrier method birth control and demonstrate a negative pregnancy test prior to initiation of protocol therapy. Periodic negative urine pregnancy tests will also be required.
- •Patients must give written informed consent
排除标准
- •No prior HD- IL-2 for stage IV/unresectable advanced disease. Prior low dose IL-2 is allowed.
- •No more than 2 prior chemotherapy regimens are allowed.
- •No active CNS metastases. Treated CNS metastases without recurrence or progression for > 8 weeks are allowed.
- •No concurrent use of systemic corticosteroids
- •Pregnant and/or lactating are excluded
- •No concurrent antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccines, or other experimental therapies.
- •No treatment for melanoma within the previous 4 weeks.
结局指标
主要结局
Primary Objective
时间窗: one - two years
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population
次要结局
未报告次要终点
研究者
Jose Lutzky
Principal Investigator Jose Lutzky, M.D.
Mt. Sinai Medical Center, Miami