A Phase II Study Of Temozolomide And Thalidomide In Patients With Metastatic Melanoma In The Brain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Response rate (defined as complete or partial)
研究概览
简要总结
This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide with thalidomide may kill more tumor cells
详细描述
OBJECTIVES: Primary I. Determine the objective response rate in patients with brain metastases secondary to melanoma treated with temozolomide and thalidomide.
Secondary I. Determine the toxic effects of and tolerance to this regimen in these patients.
II. Determine the objective response rate in extracranial metastases of patients treated with this regimen.
III. Determine the time to first disease progression (intra- or extracranial) in patients treated with this regimen.
OUTLINE: This is a multicenter study.
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 metastatic melanoma
- •Clinical evidence of brain metastases
- •At least 1 unidimensionally measurable brain lesion at least 2.0 cm by conventional techniques OR at least 1.0 cm by spiral CT scan or MRI
- •The following lesions are not considered measurable:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
- •Lesions situated in a previously irradiated area, unless new growth is documented
- •Performance status - CTC 0-1
- •Granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- •Lactic dehydrogenase no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 2 mg/dL
- •No history of active angina
- •No history of significant ventricular arrhythmia
- •No history of deep vein thrombosis
- •No myocardial infarction within the past 6 months
- •No acute abnormality by EKG
- •No uncontrolled arrhythmia
- •No history of pulmonary embolism
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use 1 highly-effective and 1 additional method of contraception for 28 days before, during, and for 4 weeks after study participation
- •No known HIV disease
- •Thyroid-stimulating hormone normal
- •Serum anticonvulsant levels normal (for patients on anticonvulsants)
- •No frequent vomiting and/or any other medical condition (e.g., partial bowel obstruction) that would preclude oral medication intake
- •No preexisting neuropathy greater than grade 1
- •No uncontrolled seizures
- •No other concurrent medical condition that would preclude study participation
- •At least 4 weeks since prior cytokines
- •Biologic agents used as adjuvants, vaccines, and cellular therapies do not require a 4-week washout period
- •No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
- •No more than 1 prior chemotherapy regimen
- •No prior chemotherapy for brain metastases
- •No prior continuous daily temozolomide
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •No other concurrent chemotherapy
- •No concurrent hormonal therapy except steroids and hormones administered for non-disease-related conditions (e.g., insulin for diabetes) or for control of intracranial edema from brain metastases
- •See Disease Characteristics
- •Prior whole brain radiotherapy (WBRT) allowed provided patient has progressive disease in a measurable CNS lesion
- •Prior stereotactic radiotherapy allowed provided patient has progressive disease in a measurable CNS lesion
- •At least 4 weeks since prior WBRT
- •At least 3 weeks since prior stereotactic radiosurgery
- •No concurrent radiotherapy
- 另有 4 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (temozolomide, thalidomide)
Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses of therapy beyond CR.
干预措施: temozolomide (Drug)
Treatment (temozolomide, thalidomide)
Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses of therapy beyond CR.
干预措施: thalidomide (Drug)
结局指标
主要结局
Response rate (defined as complete or partial)
时间窗: Up to 5 years
90% confidence intervals will be used.
次要结局
- Time to first progression(Up to 5 years)
- Overall survival(Up to 5 years)