A Phase 2 Study of Bevacizumab and Interferon-Alpha-2b in Metastatic Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Objective Response Rate
研究概览
简要总结
This randomized phase II trial is studying giving bevacizumab together with interferon alpha to see how well it works compared to giving bevacizumab alone in treating patients with metastatic malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Interferon alpha may interfere with the growth of the cancer cells and slow the growth of the tumor. Combining bevacizumab with interferon alpha may kill more tumor cells.
详细描述
OBJECTIVES:
I. Compare the objective response rate and progression-free survival in patients with metastatic malignant melanoma treated with bevacizumab with or without low- or high-dose interferon alpha.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive bevacizumab intravenously (IV) over 30-90 minutes on day 1. Patients also receive low-dose interferon alpha (IFN-alpha) subcutaneously (SC) on days 1-14.
ARM II: Patients receive bevacizumab as in arm I.
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 or cytologically confirmed cutaneous malignant melanoma
- •Must meet one of the following criteria:
- •Clinical evidence of metastatic disease
- •Unresectable regional lymphatic disease
- •Extensive in transit recurrent disease
- •Measurable disease
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan
- •No known brain metastases
- •No ocular melanoma
- •Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
- •Performance status - Karnofsky 60-100%
- •More than 6 months
- •White blood cells (WBC) at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •No clinical evidence of coagulopathy
- •Bilirubin =< 2.0 mg/dL (3.0 mg/dL for patients with Gilbert's disease provided patient is stable and asymptomatic)
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) no greater than 2.5 times upper limit of normal (ULN)
- •Prothrombin time (PT)/International normalized ratio (INR) less than 1.5
- •Creatinine =< 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •Protein < 1,000 mg on 24-hour urine collection for patients with proteinuria >= 1+
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No history of thrombosis (e.g., deep vein thrombosis), unless the following criteria are met:
- •INR in normal range (usually 2-3) AND on a stable dose of warfarin or low molecular weight heparin
- •No active bleeding or pathologic condition that would confer a high risk of bleeding (e.g., known varices or tumor involving major vessels)
- •No uncontrolled hypertension
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reactions to compounds of similar chemical or biologic composition to bevacizumab or interferon alfa
- •No ongoing or active infection
- •No other concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •Human immunodeficiency virus (HIV) allowed provided otherwise well
- •At least 4 weeks since prior adjuvant interferon alfa
- •No prior interferon alfa for metastatic disease
- •No prior cytokine therapy for metastatic disease (e.g., high-dose interleukin-2 [IL-2])
- •Prior IL-2 allowed for patients randomized to arm III only
- •No prior investigational antiangiogenic agents
- •No more than 1 prior chemotherapy regimen for metastatic disease
- •At least 4 weeks since prior chemotherapy and recovered
- •At least 4 weeks since prior radiotherapy and recovered
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Objective Response Rate
时间窗: Up to 2 years
Measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Progression-free Survival
时间窗: Up to 2 years
Defined as the time from treatment start date until documentation of progressive disease. Evaluated using the new international criteria proposed by the RECIST Committee. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
次要结局
- Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa(At baseline)
- New Vessel Formation in Patient Tumor Samples(Up to 2 years)