Phase II Trial of Moderate Dose Bolus Interleukin-2 in Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
To determine whether Interleukin-2 at the dose and schedule will help to increase tumor shrinkage
详细描述
In this phase II trial, the previously described IL-2 schedule (daily IL-2 for 5 days (per week) every 3 weeks) will be tested in a larger cohort of patients with melanoma to attempt to determine the response rate, median duration of response, and median survival. The dose intensity of this schedule would allow a patient treated on this regimen to achieve the target threshold (> 1440 million IU/m2/year).
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 a histologic diagnosis of metastatic melanoma. Patients may have received prior systemic therapy or may be previously untreated.
- •Patients must have bi-dimensional measurable disease on physical exam or radiologic studies.
- •ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
- •White blood count of > 3500/mm3, platelet count > 100,000/mm3, hemoglobin > 9.0 gm/dl; bilirubin, ALT, AST < 3 x upper limit of normal; serum creatinine < 2.0 mg/dl.
- •Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
- •Patients with elevated temperatures > 100.5 F must have sources of occult infection excluded.
- •Patients must be felt to have recovered from effects of prior therapy, such as > 2 weeks after prior chemotherapy.
- •Patient consent must be obtained prior to entrance onto study.
- •Women of childbearing potential must have a negative pregnancy test and must take adequate precautions to prevent pregnancy during treatment
排除标准
- •Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
- •Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
- •Prior history of psychiatric disorder which could be exacerbated by interleukin-
- •Lactation or pregnancy.
- •Evidence of significant cardiovascular disease including history of recent (< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
- •Current brain metastasis.
研究组 & 干预措施
Interleukin-2
Interleukin-2 will be used in this group
干预措施: Interleukin-2 (Drug)
结局指标
主要结局
Response Rate
时间窗: Measured until Disease Progression or death from any cause up to 2 years
Radiographic studies to evaluate for response were done after every 2 cycles (6 weeks) until disease progression or death from any cause up to 2 years. Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = 100%(CR + PR/total number of patients receiving Interleukin-2).
次要结局
- Median Duration of Response(Measured until Disease Progression or death from any cause up to 2 years)
- Median Survival(From time of study entry until death, up to 10 years)