NCT00095953已完成2 期
A Phase II Study of SB-715992 (NSC 727990) 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
- 17
- 试验地点
- 7
- 主要终点
- Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with metastatic or recurrent malignant melanoma.
详细描述
OBJECTIVES:
- Determine the efficacy of SB-715992, in terms of response rate, in patients with previously untreated metastatic or recurrent malignant melanoma.
- Determine the toxic effects of this drug in these patients.
- Determine the early progression rate and response duration in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
- Correlate pharmacokinetics with safety and efficacy endpoints of this drug in these patients.
- Correlate β-tubulin and kinesin spindle protein expression in tumor tissue with clinical outcomes in patients treated with this drug.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All patients are followed at 4 weeks after completion of protocol therapy. Patients with ongoing complete response, partial response, or stable disease are followed every 3 months thereafter until relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant melanoma
- •Previously untreated metastatic or recurrent disease
- •Considered incurable by standard therapies
- •Measurable disease
- •At least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Bone metastases are not considered measurable disease
- •Outside any previously irradiated area
- •Patients whose sole site of measurable disease is in a previously irradiated area are ineligible unless there is evidence of progression or new lesions documented in the irradiated field
- •No known CNS metastases
- •CT scans or MRI are not required to rule out CNS metastases unless patient exhibits neurological signs or symptoms
- •Patients with a prior solitary brain metastasis surgically resected with no evidence of residual disease are eligible provided CT scan or MRI confirms no evidence of disease within the past 28 days
- •Archival paraffin tumor specimen available
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 12 weeks
- •Hematopoietic
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin normal
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Creatinine ≤ 1.5 times 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 other malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years
- •No other uncontrolled illness
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study participation
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to SB-715992
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 3 months since prior adjuvant immunotherapy
- •No prior immunotherapy for metastatic or recurrent disease
- •Chemotherapy
- •No prior chemotherapy, including regional therapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy except for low-dose, non-myelosuppressive radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior major surgery
- •More than 28 days since prior investigational agents
- 另有 26 项未显示
排除标准
- 未提供
结局指标
主要结局
Response
时间窗: 2 years
次要结局
- Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed)(2 years)
- Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs)(2 years)
- Toxicity(2 years)
研究者
研究点 (7)
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