Phase II Study of Melanoma Vaccine (NSC #683472/675756, IND #6123) and Low-Dose, Subcutaneous Interleukin-2 in Advanced Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical response rate (CR or PR)
研究概览
简要总结
Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 in treating patients who have advanced melanoma. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Melanoma vaccine plus interleukin-2 may kill more cancer cells
详细描述
PRIMARY OBJECTIVES:
I. Determine clinical response rates in patients with advanced melanoma treated with gp100:209-217(210M) melanoma vaccine and low-dose interleukin-2.
II. Assess response duration and progression-free intervals in these patients receiving this treatment.
OUTLINE:
Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 subcutaneously (SC) on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a complete response (CR) receive 3 additional courses after achieving CR.
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 or cytologically confirmed cutaneous melanoma with clinical evidence of distant, metastatic, unresectable regional lymphatic, or extensive in-transit recurrent disease
- •HLA-A2*0201 positive by genotyping
- •Measurable disease as defined by the following:
- •At least 1 lesion accurately measured in at least 1 dimension
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •Lesions considered intrinsically nonmeasurable include:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •Lesions situated in a previously irradiated area
- •No ocular or mucosal melanoma
- •No prior or concurrent liver or brain metastases
- •Performance status - ECOG 0-1
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL
- •LDH normal
- •Bilirubin normal
- •AST no greater than 2.5 times upper limit of normal
- •Creatinine normal
- •No congestive heart failure, angina, or symptomatic cardiac arrhythmia
- •No myocardial infarction within the past 6 months
- •No severe chronic pulmonary disease
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No primary or secondary immunodeficiency or autoimmune disease
- •No currently active second malignancy (e.g., patient has completed therapy and is considered unlikely to have recurrence within 1 year) other than nonmelanoma skin cancer
- •At least 4 weeks since prior immunotherapy
- •No prior interleukin-2
- •No prior whole cell or gp100:209-217(210M)-targeted melanoma vaccine
- •No other concurrent cytokines or growth factors
- •At least 4 weeks since prior chemotherapy
- •At least 1 month since prior systemic corticosteroids
- •No concurrent systemic, inhaled, or topical corticosteroids
- •At least 1 month since other prior immunosuppressive medication
- •No antihypertensive medications from 1 day prior until 2 days after first course
排除标准
- 未提供
研究组 & 干预措施
Treatment (gp100:209-217, aldesleukin )
Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 SC on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a CR receive 3 additional courses after achieving CR.
干预措施: gp100:209-217(210M) peptide vaccine (Biological)
Treatment (gp100:209-217, aldesleukin )
Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 SC on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a CR receive 3 additional courses after achieving CR.
干预措施: laboratory biomarker analysis (Other)
Treatment (gp100:209-217, aldesleukin )
Patients receive gp100:209-217(210M) emulsified in Montanide ISA-51 SC on day 1 and interleukin-2 SC on days 1-5 and 8-13. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression. Patients with a CR receive 3 additional courses after achieving CR.
干预措施: aldesleukin (Biological)
结局指标
主要结局
Clinical response rate (CR or PR)
时间窗: From the start of treatment until disease progression/recurrence, assessed up to 3 years
次要结局
- Response duration(Up to 3 years)
- Progression-free intervals(Up to 3 years)
- Immunologic response rate using ELISPOT assay(Up to 3 years)