Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 32
- 主要终点
- Plasma b-FGF Level Response
研究概览
简要总结
RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma.
详细描述
OBJECTIVES:
- Determine the ability of low-dose PEG-interferon alfa-2b to suppress plasma basic fibroblast growth factor (b-FGF) levels to normal in patients with metastatic melanoma over-expressing b-FGF.
- Determine the antitumor effect of this drug, in terms of progression-free and overall survival and tumor response, in these patients.
- Correlate tumor activity of this drug with b-FGF and vascular endothelial growth factor levels in the plasma and urine of these patients.
- Determine the safety profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
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 confirmed stage IV melanoma
- •Stage M1a, M1b, or M1c
- •Mucosal, ocular, or unknown primary melanoma
- •Previously untreated OR received up to 3 prior systemic therapy regimens (excluding vaccine therapy) for metastatic disease
- •Plasma basic fibroblast growth factor level at least 15 pg/mL
- •Measurable or evaluable disease
- •Central nervous system (CNS) involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months
- •Brain computed tomography (CT) scan or Magnetic resonance imaging (MRI) to confirm stable disease required ≤ 4 weeks prior to study entry
- •Age: 18 and over
- •ECOG Performance status of 0-2
- •Life expectancy at least 6 months
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 8 g/dL (transfusions allowed)
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •Alanine Aminotransferase (ALT) no greater than 2 times ULN
- •Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
- •At least 4 weeks since prior interferon in the adjuvant or metastatic setting
- •At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting
- •At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting
- •At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting
- •At least 4 weeks since prior surgery in the adjuvant or metastatic setting
- •At least 4 weeks since other prior therapy in the adjuvant or metastatic setting
- •Negative pregnancy test
- •Fertile patients must use effective contraception
排除标准
- •Myocardial infarction within the past 6 months
- •Other active malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •Other concurrent illness that would preclude study participation
- •History of severe depression
- •Pregnant or nursing
研究组 & 干预措施
PEG-interferon alfa-2b
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
干预措施: PEG-interferon alfa-2b (Biological)
结局指标
主要结局
Plasma b-FGF Level Response
时间窗: assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation
The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.
次要结局
- Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)(assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years)
- Progression Free Survival(assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years)
- Overall Survival(assessed every 3 months if <2 years, and every 6 months if 2-3 years)