NCT00053781已完成2 期
A Phase II Study Of Perifosine (D-21266) In Previously Untreated Patients With Metastatic Or Recurrent 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
- 18
- 试验地点
- 6
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 perifosine in treating patients who have metastatic or recurrent malignant melanoma.
详细描述
OBJECTIVES:
- Determine the efficacy of perifosine, in terms of response rate, in previously untreated patients with metastatic or recurrent malignant melanoma.
- Assess the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral perifosine daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or partial response (PR) receive 2 additional courses after documentation of CR or stable PR (i.e., no further tumor shrinkage).
Patients are followed at 4 weeks and then every 3 months thereafter.
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 malignant melanoma
- •Metastatic or recurrent disease deemed incurable by standard therapies
- •Clinically and/or radiologically documented disease by at least 1 site that is unidimensionally measurable as follows:
- •At least 20 mm by x-ray or physical exam
- •At least 10 mm by spiral CT scan
- •At least 20 mm by non-spiral CT scan
- •Bone lesions are not considered measurable
- •Outside previously irradiated area unless evidence of progression or new lesions within irradiated field
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •AST no greater than 2.5 times ULN
- •Creatinine no greater than ULN
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reactions to compounds of similar chemical or biological composition to perifosine
- •No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- •No ongoing or active infection
- •No other concurrent uncontrolled medical illness, psychiatric illness, or social situation that would preclude study entry
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 months since prior adjuvant immunotherapy
- •No prior immunotherapy for recurrent/metastatic disease
- •Chemotherapy
- •No prior chemotherapy (including regional therapy)
- •No other concurrent cytotoxic chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy (except for low-dose, nonmyelosuppressive radiotherapy)
- •At least 4 weeks since prior major surgery
- •No other concurrent anticancer therapy or investigational agents
排除标准
- 未提供
研究者
研究点 (6)
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