NCT00026143已完成2 期
Phase II Trial of Interleukin-12 (NSC #672423, IND #6798) Followed by Interferon Alfa-2B in Patients With Metastatic Malignant Melanoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in treating patients who have metastatic malignant melanoma. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells. Interferon alfa may interfere with the growth of the cancer cells. Combining interleukin-12 and interferon alfa may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the clinical response rates in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b.
II. To estimate the progression-free survival in patients with metastatic malignant melanoma treated with rhIL-12 and interferon alfa-2b.
SECONDARY OBJECTIVES:
I. To measure serum levels of interferon-gamma. II. To measure levels of JAK-STAT signaling intermediates in patient PBMCs and tumor samples.
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
- •Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of distant, metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease
- •Patients must have measurable disease; measurable disease is defined as the presence of at least one measurable lesion; if the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology; measurable lesions are defined as lesions that can be accurately measured in at least one dimension with the longest diameter >= 20 mm using conventional techniques or >= 10 mm with spiral CT scan
- •Lesions that are considered intrinsically non-measurable include the following:
- •Bone lesions;
- •Leptomeningeal disease;
- •Pleural/pericardial effusion;
- •Inflammatory breast disease;
- •Lymphangitis cutis/pulmonis;
- •Abdominal masses that are not confirmed and followed by imaging techniques;
- •Lytic lesions;
- •Lesions that are situated in a previously irradiated area
- •No history of peripheral neuropathy, brain metastases or other central nervous system disease
- •No history of/active autoimmune disease, hemolytic anemia or concurrent requirement for corticosteroids, including topical or inhaled
- •No hepatitis BSAg, known HIV disease or other major active illness; patients with risk factors for HIV should be tested; patients with these illnesses are more likely to experience significant side effects from the study treatment
- •No history of severe peptic ulcer disease or gastrointestinal bleeding unless there is objective evidence that the condition is inactive or resolved
- •No uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection
- •No chemotherapy, radiotherapy, or anti-hormonal therapy within three weeks prior to the initiation of therapy on this study
- •No prior therapy with IL-12
- •No prior therapy with IFN-alpha for metastatic disease (e.g., biochemotherapy); prior adjuvant therapy with IFN-a is acceptable as long as the patient remained disease-free for 12 months or longer following the last IFN-a treatment
- •No prior cytokine therapy for metastatic disease (e.g., high-dose IL-2)
- •No more than one prior chemotherapy regimen
- •CTC (ECOG) performance status 0-1
- •Non-pregnant, non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control; women of child-bearing age will undergo pregnancy testing
- •ANC >= 1500/μL
- •Platelets >= 100,000/μL
- •Hemoglobin > 9 g/dL (may be post transfusion or may receive EPO)
- •U-HCG or Serum HCG Negative (if patient of child-bearing potential)
排除标准
- 未提供
结局指标
主要结局
Response rate
时间窗: Up to 2 years
PFS
时间窗: From registration until time of documented progression of disease or death from any cause, assessed up to 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
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