NCT00002669已完成2 期
TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL
European Organisation for Research and Treatment of Cancer - EORTC24 个研究点 分布在 9 个国家目标入组 90 人开始时间: 1995年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 24
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. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.
PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.
详细描述
OBJECTIVES:
- Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.
- Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses.
Patients are followed every 2 months for 6 months, then every 3 months thereafter.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed melanoma that is metastatic and unresectable
- •Measurable, progressive disease (by physical exam and/or noninvasive imaging)
- •No prior irradiation of indicator lesions
- •No CNS metastases (confirmed by CT or MRI)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •Greater than 3 months
- •Hematopoietic:
- •WBC at least 2,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No serious hepatic disease
- •Creatinine no greater than 1.65 mg/dL
- •No serious renal disease
- •Cardiovascular:
- •No serious cardiac disease
- •No serious pulmonary disease
- •No organ allograft
- •No autoimmune disease
- •No uncontrolled infection
- •No active peptic ulcer
- •No hyper or hypothyroidism
- •No requirement for corticosteroids
- •No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunotherapy with interleukin-2
- •No prior interferon alfa in combination with cisplatin or dacarbazine
- •Chemotherapy:
- •No prior chemotherapy with cisplatin in combination with dacarbazine
- •More than 3 months since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior radiotherapy allowed
- •Not specified
排除标准
- 未提供
研究者
研究点 (24)
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