NCT00005971已完成2 期
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Previously Untreated Metastatic Malignant Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 50
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.
PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have metastatic malignant melanoma.
详细描述
OBJECTIVES:
- Assess the efficacy of flavopiridol in patients with previously untreated metastatic malignant melanoma.
- Assess the toxicity of this treatment in these patients.
- Assess the time to progression, early progression rate, and response duration in these patients when treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment continues every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks, and then every 3 months until disease progression or death.
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 120 Years（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 not amenable to standard curative therapies
- •No prior regional or systemic therapy for metastatic disease
- •Measurable disease
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •Bone lesions not considered measurable
- •No known CNS metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than upper limit of normal (ULN)
- •AST no greater than 2.5 times ULN
- •Creatinine no greater than ULN
- •Cardiovascular:
- •If history of cardiac disease, ejection fraction greater than 50%
- •No clinically significant cardiac symptomology
- •If history of pulmonary disease, FEV1, FVC, and TLC greater than 60% predicted and DLCO greater than 50% predicted
- •No clinically significant pulmonary symptomology
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other concurrent serious disease
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior adjuvant immunotherapy allowed
- •No prior immunotherapy for metastatic disease
- •Chemotherapy:
- •No prior chemotherapy for metastatic disease
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •At least 4 weeks since prior adjuvant hormonal therapy
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •Must have measurable disease outside irradiated area OR
- •Evidence of progression or new lesions in irradiated area
- •No more than 25% of functioning bone marrow irradiated
- •No concurrent radiotherapy to sole site of measurable disease
- •At least 4 weeks since prior major surgery
- •No other concurrent anticancer therapy or investigational anticancer agents
排除标准
- 未提供
研究者
研究点 (50)
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