NCT00072345已完成2 期
A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide and thalidomide with lomustine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide with lomustine in treating patients who have unresectable stage III or stage IV melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of temozolomide, thalidomide, and lomustine, in terms of objective response rate, in patients with unresectable stage III or stage IV melanoma.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the duration of response and overall survival of patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic malignant melanoma
- •Unresectable stage III OR stage IV disease
- •Ocular, mucosal, and cutaneous melanoma allowed
- •Measurable disease
- •Indicator lesions within a prior radiotherapy field must have recent evidence of disease progression
- •Indicator lesions must be distinct from the surgical and/or radiation changes induced by prior local therapies
- •No more than 2 symptomatic hemorrhagic lesions in the brain
- •No hemorrhagic lesion(s) greater than 1 cm in diameter
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Karnofsky 80-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •SGOT and SGPT no greater than 2 times ULN
- •Alkaline phosphatase no greater than 2 times ULN
- •Lactic dehydrogenase no greater than 2 times ULN
- •Creatinine no greater than 2 mg/dL
- •Cardiovascular
- •No history of severe cardiovascular disease
- •No myocardial infarction within the past 6 months
- •No unstable angina
- •No New York Heart Association class III or IV congestive heart failure
- •No ventricular arrhythmia
- •No uncontrolled arrhythmia
- •Gastrointestinal
- •No frequent vomiting
- •No other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 4 weeks after study participation
- •HIV negative
- •No AIDS-related illness
- •No serious infection requiring IV antibiotics
- •No other uncontrolled medical illness that would preclude study participation
- •No other malignancy within the past 2 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer meeting all of the following criteria:
- •Detected incidentally at transurethral resection of the prostate (TURP)
- •Comprises less than 5% of resected tissue
- •Prostate-specific antigen normal since TURP
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 weeks since prior immunotherapy or biologic therapy
- •No concurrent immunotherapy
- •Chemotherapy
- •No prior systemic chemotherapy for melanoma
- 另有 14 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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