A Phase II Study of Anti-angiogenesis Therapy for Metastatic Melanoma Using ABT-510
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 42
- 主要终点
- 18-week progression-free survival rate
研究概览
简要总结
RATIONALE: ABT-510 may stop the growth of melanoma by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well giving ABT-510 works in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
- Examine the safety profile of ABT-510 in patients with metastatic malignant melanoma.
- Examine the antitumor activity (i.e., time to progression and response rates) in patients treated with ABT-510.
- Determine the pharmacodynamic effects of ABT-510 and its potential impact on immune cell function in these patients.
OUTLINE: Patients receive ABT-510 subcutaneously twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are obtained at baseline, before treatment on day 1 of cycles 2 and 3, and then every other course thereafter for pharmacological and ancillary studies. Samples are evaluated for EC enumeration, expression profiling, circulating tumor cell quantification, analysis of T-cell functions (i.e., immunophenotyping for NK-, T- and B-cell phenotypes as well as ELISPOT analysis against common environmental pathogens and T cell spectratyping), and angiogenesis bioassays. Patients also undergo ultrasound-guided core tumor biopsies for histological analysis of microvascular density (CD38 and von Willebrand Factor immunohistochemistry) at baseline and before treatment on day 1 of courses 3 and 5.
After completion of study treatment, patients are followed every 3 months for up to 5 years.
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 malignant melanoma
- •Stage IV disease
- •No known potentially curative standard therapy that exists or is proven capable of extending life expectancy
- •Measurable disease
- •No history of or current CNS metastases
- •MRI of the brain to confirm absence of CNS metastases within the past 28 days is required
- •No known, presently active carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 6 months
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Alkaline phosphatase ≤ 3 times upper limit of normal (ULN)
- •AST ≤ 3 times ULN
- •Creatinine ≤ 2.5 times ULN
- •Hemoglobin ≥ 9.0 g/dL
- •Prothrombin time normal
- •Willing to return to Mayo Clinic Rochester, Jacksonville or Scottsdale for follow-up
- •Must be able to self-administer or has a caregiver who can reliably administer subcutaneous injections
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No uncontrolled or current infection
- •No New York Heart Association class III-IV heart disease
- •No recent history of (i.e., ≤ 12 weeks from study day 1) or current cancer-related bleeding event (e.g., hemoptysis)
- •No recent history of (within the past 4 weeks) or current noncancer-related clinically significant bleeding event
- •No uncontrolled hypertension
- •No history of stroke or other CNS bleeding events (e.g., aneurysms)
- •PRIOR CONCURRENT THERAPY:
- •At least 4 weeks since prior chemotherapy and recovered (6 weeks for mitomycin C or nitrosoureas)
- •At least 4 weeks since prior immunotherapy, biologic therapy, radiotherapy, or surgery
- •No concurrent anticoagulation therapy or antiplatelet therapy
- •No other concurrent antineoplastic agents (e.g., cytotoxic chemotherapy, immunotherapy, radiotherapy, or investigational therapy) except local radiotherapy for supportive reasons involving a small radiation field
排除标准
- 未提供
结局指标
主要结局
18-week progression-free survival rate
次要结局
- Objective response rate as defined by RECIST criteria
- Overall survival time
- Frequency of NK-cells, T-cells, and B-cells before the start of the first 5 courses of treatment