High Dose Interleukin-2 (IL-2) Therapy In "Lymphodepleted Primed" Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with high-dose interleukin-2 works in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in lymphodepleted patients with metastatic melanoma treated with cyclophosphamide, fludarabine, and high-dose interleukin-2.
- Determine the feasibility of this regimen in these patients.
Secondary
- Determine the quality and quantity of lymphocyte recovery in these patients during and after treatment with this regimen.
- Determine time to disease progression and survival in patients treated with this regimen.
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
- •Histologically confirmed melanoma
- •Metastatic disease
- •Measurable disease
- •No history of brain metastases
- •Karnofsky 60-100%
- •Life expectancy At least 12 weeks
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Hemoglobin ≥ 8.5 g/dL
- •aspartate aminotransferase ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- •Bilirubin ≤ 2 times ULN (except for patients with Gilbert's syndrome)
- •Hepatitis B and C negative
- •Creatinine ≤ 2.0 times ULN
- •Creatinine clearance ≥ 50 mL/min
- •Cardiovascular
- •Ejection fraction ≥ 50%
- •No evidence of congestive heart failure
- •No symptoms of coronary artery disease
- •No serious cardiac arrhythmias
- •No myocardial infarction within the past 6 months
- •Cardiac stress test negative or of low probability for patients > 40 years of age OR who have had prior myocardial infarction > 6 months ago
- •Pulmonary Forced expiratory volume 1 ≥ 2.0 liters OR at least 75% of predicted for height and age
- •Diffusing capacity of lung for carbon monoxide ≥ 60%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
排除标准
- •No uncontrolled diabetes
- •No history of autoimmune disease
- •No active infection
- •No other concurrent significant illness that would preclude study participation
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or non-invasive cancer (e.g., carcinoma in situ of the cervix, superficial bladder cancer without local recurrence, or carcinoma in situ of the breast)
- •At least 4 weeks since prior immunotherapy and recovered
- •No other concurrent anticancer biologic agents
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- •No concurrent chemotherapy
- •At least 4 weeks since prior steroid therapy
- •No concurrent corticosteroids
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •At least 4 weeks since prior surgery and recovered
- •No concurrent immunosuppressive therapy
研究组 & 干预措施
IL-2, CTX, fludarabine, GM-CSF
Aldesleukin (IL-2), cyclophosphamide, fludarabine phosphate, sargramostim
干预措施: aldesleukin (Biological)
IL-2, CTX, fludarabine, GM-CSF
Aldesleukin (IL-2), cyclophosphamide, fludarabine phosphate, sargramostim
干预措施: sargramostim (Biological)
IL-2, CTX, fludarabine, GM-CSF
Aldesleukin (IL-2), cyclophosphamide, fludarabine phosphate, sargramostim
干预措施: cyclophosphamide (Drug)
IL-2, CTX, fludarabine, GM-CSF
Aldesleukin (IL-2), cyclophosphamide, fludarabine phosphate, sargramostim
干预措施: fludarabine phosphate (Drug)
结局指标
主要结局
Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST
时间窗: Response at 12 weeks
Objective response as measured by radiological and physical examination using RECIST criteria.
次要结局
- Number of Participants With Lymphocyte Recovery as Measured by Blood Count(on days 1-15, weekly for 2 weeks, and then every 2-3 months)
- Time to Progression as Measured by RECIST(From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months)