NCT01833767撤回2 期
Phase 2 Trial of T-cell Based Low-dose Cyclophosphamide and Outpatient Intravenous Interleukin-2 in Metastatic Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
The purpose of this study is to determine response rates by administering low dose cyclophosphamide on day 1, followed by 5 days of outpatient IL2.
详细描述
To determine the response rate, median duration of response and median survival of patients treated with this low-dose cyclophosphamide + moderate dose bolus Interleukin-2 schedule.
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 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.
- •Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
- •Patient consent must be obtained prior to entrance onto study.
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 untreated brain metastasis.
研究组 & 干预措施
Cyclophosphamide and Interleukin-2
Experimental
Cytoxan IV on day 1, IL2 IV on days 1-5
干预措施: Cyclophosphamide and Interleukin 2 (Drug)
结局指标
主要结局
Response Rate
时间窗: One year
次要结局
- Median Survival(One year)
研究者
Jordan Waypa
Research Director
Western Regional Medical Center
研究点 (1)
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