A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor. Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic melanoma that has been previously treated
详细描述
PRIMARY OBJECTIVES:
I. Determine the objective response rate and stabilization of disease rates of patients with previously treated metastatic melanoma treated with SU5416.
II. Determine the toxicity of SU5416 in this patient population. III. Determine the median and overall survival and time to progression in these patients receiving this treatment.
OUTLINE: This is a multicenter study.
Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed melanoma with documented metastatic disease
- •In transit metastases allowed
- •Lesion accessible for biopsy
- •Measurable disease
- •Greater than 20 mm by conventional techniques ORgreater than 10 mm by spiral CT
- •Documented progressive disease by radiologic study or physical examination
- •Known history of CNS metastasis who have had treatment, are neurologicallystable, and do not require intravenous antibiotics or anticonvulsants eligibleprovided oral steroids are not required and brain scan (CT or MRI) showsabsence of active or residual disease
- •If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required
- •Performance status - WHO 0-2
- •At least 12 weeks
- •WBC at least 3,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •Transaminases no greater than 2.5 times upper limit of normal
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No uncompensated coronary artery disease
- •No history of myocardial infarction or severe/unstable angina within past 6 months
- •No severe peripheral vascular disease associated with diabetes mellitus
- •No deep venous or arterial thrombosis within past 3 months
- •No pulmonary embolism within past 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other significant uncontrolled underlying medical or psychiatric illness
- •No serious active infections
- •No other malignancy within past 5 years except for curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel
- •No other concurrent chemotherapy
- •No other concurrent investigational antineoplastic drugs
- •See Disease Characteristics
- •No prior radiotherapy to only site of measurable disease
- •At least 4 weeks since prior radiotherapy and recovered
- •No concurrent radiotherapy
- •No greater than 1 prior therapy for metastatic disease
- •At least 4 weeks since prior therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (semaxanib)
Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
干预措施: semaxanib (Drug)
Treatment (semaxanib)
Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Complete response rate
时间窗: Up to 3 years
Overall response rate (complete and partial responses)
时间窗: Up to 3 years
Maintenance of stable disease
时间窗: Up to 3 years
Treatment toxicity
时间窗: Up to 4 weeks post treatment
Time to progression
时间窗: Up to 3 years
Kaplan-Meier estimates will be calculated.
Survival
时间窗: Up to 3 years
Kaplan-Meier estimates will be calculated.
次要结局
未报告次要终点