A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage IV melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
详细描述
OBJECTIVES:
I. Determine the efficacy of BMS-247550 in patients with stage IV melanoma. II. Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to the number of prior chemotherapy regimens (0 vs 1-2, including dacarbazine or temozolomide).
Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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 or cytologically confirmed stage IV melanoma
- •At least 1 measurable lesion
- •Greater than 20 mm by conventional techniques
- •Greater than 10 mm by spiral CT scan
- •Known brain metastases allowed if all of the following criteria are met:
- •Radiologically stable for at least 6 weeks after completion of whole brain radiotherapy
- •Stable at time of study
- •No mass effect present radiologically
- •No concurrent steroids to control symptoms of brain metastases
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •At least 3 months
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST/ALT no greater than 2.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN
- •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 severe allergic reactions (grade III or IV or grade II not responsive to steroids) to taxanes or medications containing Cremophor EL
- •No pre-existing grade 2 or greater peripheral neuropathy
- •No HIV-positive patients receiving combination antiretroviral therapy
- •No other concurrent uncontrolled illness
- •No ongoing or active infection
- •No psychiatric illness that would preclude study
- •Prior vaccine therapy allowed
- •Prior immunotherapy (e.g., interleukin-2 or interferon) allowed
- •Stratum I:
- •No prior chemotherapy
- •Stratum II:
- •No more than 2 prior chemotherapy regimens (must have included dacarbazine or temozolomide)
- •See Disease Characteristics
- •See Disease Characteristics
- •Prior limb-perfusion therapy allowed (stratum II)
- •No other concurrent investigational or commercial agents or therapies intended to treat malignancy
- •No concurrent Hypericum perforatum
排除标准
- 未提供
研究组 & 干预措施
Treatment
Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: ixabepilone (Drug)
Treatment
Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacogenomic studies (Other)
Treatment
Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response rate
时间窗: Up to 2 years
The 95% confidence intervals will be provided.
次要结局
- Median time to progression(Time from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 years)
- Incidence of related toxicities graded according to the revised NCI CTC version 2.0(Up to 2 years)