NCT00398450已完成1 期
A Phase I Study of 5-azacytidine (Vidaza) With Interferon α2b in Metastatic Melanoma Patients
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Interferon alfa may interfere with the growth of tumor cells. Giving azacitidine together with interferon alfa may be an effective treatment for melanoma.
PURPOSE: This phase I trial is studying the side effects and best dose of azacitidine when given together with interferon alfa in treating patients with metastatic melanoma.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of azacitidine in combination with interferon alfa-2b in patients with metastatic melanoma.
- Determine if the MTD of this regimen is biologically active in these patients.
- Define and describe the toxicities associated with this regimen.
Secondary
- Determine, preliminarily, the response in patients treated with this regimen.
- Describe, preliminarily, the time to progression and overall survival of patients treated with this regimen.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic melanoma
- •At least one lesion appropriate for 3 separate punch or core needle biopsies
- •Must have received and failed ≥ 1 prior systemic treatment for metastatic disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT < 2 times ULN
- •Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known allergies to azacitidine, interferon alfa, benzyl alcohol, or mannitol
- •No uncontrolled infection
- •No known HIV positivity
- •No hepatitis B or hepatitis C infection
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 3 weeks since prior systemic therapy
- •More than 4 weeks since prior radiotherapy to target lesions with evidence of progression
- •No concurrent radiotherapy to target lesions
- •No concurrent oral or IV corticosteroids
- •Topical creams or ocular steroid drops are allowed
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
Toxicity
次要结局
- Response
- Relapse-free survival
- Survival at day 1, 12 months, 3 years, and 5 years
- Time to relapse
研究者
Gregory Daniels
Professor
University of California, San Diego
研究点 (2)
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