NCT00003802已完成2 期
A Phase II Trial of Pyrazoloacridine (NSC 366140, IND 36325) in Metastatic Cutaneous and Ocular Melanoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
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 pyrazoloacridine in treating patients who have metastatic skin or eye melanoma.
详细描述
OBJECTIVES:
- Assess the antitumor activity of pyrazoloacridine (PZA) in chemotherapy naive patients with metastatic cutaneous or ocular melanoma.
- Determine the toxic effects of PZA in this patient population.
- Determine the pharmacokinetic profile of PZA in these patients.
OUTLINE: Patients are stratified into cutaneous or ocular melanoma treatment groups.
Patients receive pyrazoloacridine IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 28-70 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 metastatic cutaneous or ocular melanoma that is chemotherapy naive
- •Bidimensionally measurable disease
- •No pleural effusions or ascites
- •No untreated CNS metastases
- •Stable brain metastases by CT or MRI scan
- •At least 4 weeks since prior steroid therapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN (unless due to hepatic metastases)
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No active infection
- •No known hypersensitivity to E.coli derived proteins
- •No other serious medical problems
- •No more than 1 primary malignancy within past 5 years, other than:
- •Nonmelanomatous skin cancer
- •Carcinoma in situ of the cervix
- •No history of spinal cord compression
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior biologic therapy allowed (e.g., interleukin-2, interferon alfa, or vaccine therapy)
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •See Disease Characteristics
- •Radiotherapy:
- •Prior radiotherapy for primary ocular melanoma, brain metastases, or to metastatic sites encompassing less than 25% of the bone marrow allowed
- •No other prior radiotherapy
- •At least 2 weeks since prior surgery and recovered
排除标准
- 未提供
研究者
研究点 (1)
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