NCT00036842已完成2 期
Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 186
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating men who have germ cell cancer that has not responded to previous treatment.
详细描述
OBJECTIVES:
- Determine the response rate (confirmed complete and partial responses) in men with refractory testicular or extragonadal germ cell malignancies treated with arsenic trioxide.
- Determine the overall and progression-free survival of patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Assess the biomarker response rate in patients with elevated biomarkers treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive arsenic trioxide IV over 1-2 hours on days 1-5. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete or partial response receive up to 3 additional courses past response.
Patients are followed every 2 months for 3 years or until disease progression.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed testicular or extragonadal germ cell cancer
- •Refractory disease, defined by at least 1 of the following criteria:
- •Disease progression during or within 4 weeks of cisplatin-containing regimen
- •Progression is defined as the appearance of new or progression of known locally advanced or metastatic disease or a rise in tumor markers (beta-human chorionic gonadotropin (beta-HCG) or alpha fetoprotein (AFP)) by at least 50% relative to the nadir
- •When the only evidence of germ cell progression or recurrence before study entry is the appearance of a new lesion in the absence of tumor marker elevation, a biopsy is required to confirm the diagnosis
- •Disease recurrence after at least 2 chemotherapy regimens, one of which includes high-dose therapy (chemotherapy with stem cell support)
- •Disease recurrence after at least 2 chemotherapy regimens and not eligible for high-dose therapy
- •At least 1 of the following:
- •Unidimensionally measurable disease
- •Soft tissue, irradiated within the past 2 months, is not considered measurable
- •Elevated beta-HCG (more than 20 mIU/mL)
- •AFP greater than 2 times upper limit of normal
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status:
- •Zubrod 0-2
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •WBC at least 3,000/mm^3
- •Bilirubin less than 2.5 times upper limit of normal (ULN)
- •SGOT less than 5 times ULN
- •Alkaline phosphatase less than 5 times ULN
- •Creatinine no greater than 2.5 times ULN OR
- •Creatinine clearance at least 40 mL/min
- •Potassium normal
- •Magnesium normal
- •No renal dialysis
- •Cardiovascular:
- •No prior torsades de pointes-type ventricular arrhythmia
- •No prolonged QT interval (greater than 450 msec) on ECG in presence of normal potassium and magnesium
- •Fertile patients must use effective contraception
- •No active serious infection not controlled by antibiotics
- •No known hypersensitivity to arsenic
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II disease in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •See Disease Characteristics
- •More than 28 days since prior cytotoxic agents
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 28 days since prior radiotherapy and recovered
- •Not specified
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (186)
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