NCT00003641进行中（未招募）3 期
Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage T2bN0, T3a-bN0, T4a-bN0, and T1-4, N1a,2a (Microscopic) Melanoma
ECOG-ACRIN Cancer Research Group973 个研究点 分布在 1 个国家目标入组 1,150 人开始时间: 1999年3月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,150
- 试验地点
- 973
- 主要终点
- 5-year Relapse-free Survival Rate
研究概览
简要总结
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.
PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.
详细描述
OBJECTIVES:
Primary Objective:
- Compare the effect of high-dose interferon alfa-2b treatment on the relapse-free survival of patients with stage II or III resected malignant melanoma.
Secondary Objectives:
- Compare the effect of this treatment regimen on overall survival of these patients.
- Assess the toxicity of this treatment in these patients.
- Compare the effect of treatment on quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 primary melanoma of cutaneous origin
- •Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)
- •Clinically negative regional lymph node pathologic status unknown OR
- •Histologically negative regional lymph nodes
- •Stage III (T4 N0 M0)
- •Greater than 4.0 mm Breslow depth OR
- •Stage III (T1-4 N1)
- •One lymph node positive microscopically
- •Patients must meet at least 1 of the following criteria:
- •T2b N0 - primary melanoma 1.01-2.0 mm with ulceration, node negative
- •T3a-b N0 - primary melanoma 2.01-4.0 mm with and without ulceration, node negative
- •T4a-b N0 - primary melanoma > 4.0 mm with or without ulceration, node negative
- •T1a N1a-2a (microscopic) - primary melanoma of any thickness with microscopically positive lymph node (any number)
- •Patients with a positive sentinel node should undergo complete lymphadenectomy of the nodal basin prior to study
- •Must complete all primary therapy (wide excision with or without lymphadenectomy) and be randomized in this study within 84 days of wide excision
- •Must have undergone an adequate wide excision of the primary lesion
- •Age 18 and over (For ECOG patients only, patients must be >=10 years)
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1
- •Adequate hematopoietic, hepatic, and renal function based on the following tests:
- •White blood cell (WBC) cout at least 3,000/mm^3
- •Platelet count at least 125,000/mm^3
- •Hematocrit at least 30%
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •Aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and alkaline phosphatase no greater than 2 times ULN
- •If lactate dehydrogenase or alkaline phosphatase is above normal, a contrast-enhanced computed tomography (CT) scan or Magnetic resonance imaging (MRI) of the liver is required to document the absence of tumor
- •Blood urea nitrogen (BUN) no greater than 33 mg/dL OR Creatinine no greater than 1.8 mg/dL
- •No other concurrent or prior malignancies within the past 5 years except:
- •Cancer in situ
- •Lobular carcinoma in situ of the breast
- •Carcinoma in situ of the cervix
- •Atypical melanocytic hyperplasia or Clark 1 melanoma in situ
- •Basal or squamous cell skin cancer
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study
排除标准
- •Clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
- •Clinically palpable lymphadenopathy
- •Evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation
- •Other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation
- •Pregnant or nursing
- •Other history of invasive melanoma
- •Autoimmune disorders or conditions of immunosuppression
- •History of active ischemic heart disease
- •Cerebrovascular disease
- •Congestive heart failure (New York Heart Association class III or IV heart disease)
- •Prior or concurrent chemotherapy
- •Prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma
- •Concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers
- •Prior or concurrent radiotherapy
- •Other concurrent immunosuppressive medications
研究组 & 干预措施
Observation
Other
Patients undergo observation for 4 weeks.
干预措施: observation (Other)
Interferon Alfa-2b
Experimental
Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.
干预措施: interferon alfa-2b (Biological)
结局指标
主要结局
5-year Relapse-free Survival Rate
时间窗: assessed every 3 months for 2 years, every 6 months for 3 years
Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients.
次要结局
- 5-year Overall Survival Rate(assessed every 3 months for 2 years, every 6 months for 3 years)
研究者
研究点 (973)
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