NCT00085306已完成2 期
Phase II Trial Of Interferon-B In Patients With Metastatic Cutaneous Melanoma And Metastatic Ocular Melanoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Objective clinical response rate to IFN-B the maximum tolerated dose as measured by a CTC Grade III hematologic or a Grade IV granulocyte toxicity which persists > 3 days at 1 week after each course
研究概览
简要总结
RATIONALE: Interferon beta may interfere with the growth of tumor cells.
PURPOSE: This phase II trial is studying how well interferon beta works in treating patients with metastatic cutaneous (skin) melanoma or ocular (eye) melanoma.
详细描述
OBJECTIVES:
- Determine the objective clinical response rate in patients with metastatic cutaneous or ocular melanoma treated with interferon beta.
- Determine the frequency and degree of apoptosis induction in patients treated with this drug.
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to type of melanoma (ocular vs cutaneous).
Patients receive interferon beta subcutaneously once daily in the absence of disease progression or unacceptable toxicity.
Patients are followed within 3 days after completion of study treatment and then for survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic melanoma
- •Cutaneous or ocular disease
- •Measurable disease
- •No active unstable CNS metastases by neurologic exam AND CT scan or MRI
- •Irradiated and/or resected CNS lesions allowed if there is no evidence of disease by head MRI or CT scan for > 6 months after surgery and/or radiotherapy
- •Patients with cutaneous metastases and previously irradiated and/or resected CNS metastases are eligible if the CNS metastases are controlled and do not require dexamethasone
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •ECOG 0-1 (0-2 for patients with cutaneous metastases)
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,200/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9.5 g/dL
- •Bilirubin ≤ 1.5 mg/dL
- •AST ≤ 3.0 times normal
- •Alkaline phosphatase ≤ 2.5 times normal (10 times normal if due to bone metastases)
- •Hepatitis B surface antigen negative
- •Creatinine ≤ 1.5 mg/dL
- •Cardiovascular
- •No serious cardiac arrhythmia requiring treatment
- •No congestive heart failure
- •No angina pectoris
- •No New York Heart Association class II-IV heart disease
- •No other severe cardiovascular disease
- •HIV negative
- •No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the uterine cervix
- •No history of seizure disorder
- •No severe psychiatric disorder
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •More than 12 months since prior adjuvant interferon alfa-2 (IFNα-2) therapy
- •More than 30 days since prior IFNα-2 therapy for metastatic disease (6 months for patients with cutaneous metastases)
- •No more than 1 prior systemic regimen (chemotherapy or biologic) for metastatic disease (3 regimens for patients with cutaneous metastases)
- •Chemotherapy
- •See Biologic therapy
- •No concurrent chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •Concurrent replacement therapy with physiologic doses of corticosteroids allowed
- •No concurrent dexamethasone or other steroidal antiemetics or anti-inflammatories
- •No other concurrent hormonal agents except steroids administered for preexisting adrenal failure or hormones administered for non-disease-related conditions (e.g., insulin for diabetes)
- •Radiotherapy
- •See Disease Characteristics
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排除标准
- 未提供
研究组 & 干预措施
Recombinant interferon beta
Experimental
干预措施: recombinant interferon beta (Biological)
结局指标
主要结局
Objective clinical response rate to IFN-B the maximum tolerated dose as measured by a CTC Grade III hematologic or a Grade IV granulocyte toxicity which persists > 3 days at 1 week after each course
次要结局
未报告次要终点
研究者
研究点 (1)
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