NCT00003027已完成3 期
A Randomized Phase III Trial of Concurrent Biochemotherapy With Cisplatin, Vinblastine, Dacarbazine, IL-2 and Interferon A-2B Versus Cisplatin, Vinblastine, Dacarbazine Alone in Patients With Metastatic Malignant Melanoma
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 482
- 试验地点
- 94
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use 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 melanoma cells. Interferon alfa may interfere with the growth of tumor cells. It is not yet known whether combination chemotherapy plus interleukin-2 and interferon alfa is more effective than combination chemotherapy alone for metastatic melanoma.
PURPOSE: Randomized phase III trial to compare combination chemotherapy with or without interleukin-2 and interferon alfa in treating patients who have metastatic melanoma that cannot be treated by surgery.
详细描述
OBJECTIVES:
- Compare response rate, duration of response, and survival rate in patients with metastatic malignant melanoma treated with cisplatin, vinblastine, and dacarbazine with or without interleukin-2 and interferon alfa-2b.
- Determine the toxic effects of these regimens in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to performance status (0 vs 1), prior interferon (yes vs no), and number of involved sites. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive cisplatin IV over 30 minutes daily immediately followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 60 minutes on day 1 following vinblastine.
- Arm II: Patients receive treatment as in arm I. Patients also receive interleukin 2 (IL-2) IV continuously on days 1-4 and interferon alfa-2b subcutaneously (SC) daily before IL-2 on days 1-4 and after IL-2 on day 5, followed by filgrastim (G-CSF) (SC) daily on days 7-16.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed surgically incurable metastatic malignant melanoma
- •Measurable disease
- •No active brain metastases or edema
- •No leptomeningeal disease
- •No ocular melanoma
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT less than 3 times the upper limit of normal unless due to liver metastases
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance at least 75 mL/min
- •Cardiovascular:
- •No congestive heart failure
- •No symptoms of coronary artery disease
- •No serious cardiac arrhythmias
- •No prior myocardial infarction on EKG
- •Normal cardiac stress test required for the following:
- •Over 50 years of age
- •Abnormal EKG
- •Prior history of cardiac disease
- •No symptomatic pulmonary disease
- •FEV1 greater than 2.0 L OR at least 75% predicted if over 50 years of age or with history of pulmonary symptoms
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No significant infection
- •HIV negative
- •No other prior malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No organ allografts
- •No significant disease other than malignancy
- •No seizure disorder
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior interleukin-2 therapy for metastatic disease
- •At least 4 weeks since prior vaccine therapy
- •At least 4 weeks since prior adjuvant immunotherapy
- •Chemotherapy:
- •No prior chemotherapy for disease
- •Endocrine therapy:
- •No concurrent corticosteroids
- •Radiotherapy:
- •No prior radiation therapy to measurable disease site unless disease is clearly progressive
- 另有 4 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Response rate (complete and partial response)
- Durable complete response rate
- Response duration
研究者
研究点 (94)
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