A Phase II Trial of Intravenous Administration of Reovirus Serotype 3 - Dearing Strain (Reolysin®) in Patients With Metastatic Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Tumor Response
研究概览
简要总结
This phase II trial is studying the side effects and how well viral therapy works in treating patients with metastatic melanoma. Viral therapy may be able to kill tumor cells without damaging normal cells.
详细描述
PRIMARY OBJECTIVES:
I. Assess the antitumor effect of wild-type reovirus (Reolysin®), in terms of tumor response rate and clinical benefit rate (i.e., partial response and complete response), in patients with metastatic melanoma.
II. Assess the toxicity profile of Reolysin® in these patients.
SECONDARY OBJECTIVES:
I. Assess the progression-free survival and overall survival of these patients. II. Assess viral replication in metastatic melanoma deposits after intravenous administration of Reolysin®.
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 or cytologically confirmed malignant melanoma
- •All melanomas, regardless of origin, are allowed
- •Metastatic disease
- •Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20mm by conventional techniques or as ≥ 10 mm by spiral CT scan
- •Must have ≥ 1 metastatic lesion that can be safely biopsied
- •Must have received ≥ 1 prior treatment for metastatic disease
- •Not a candidate for curative surgery for metastatic disease
- •No known brain metastases
- •Eastern Cooperative Oncology Group performance status 0-2
- •Life expectancy > 12 weeks
- •Total White Blood Cell (WBC) ≥ 3,000/mcL
- •Absolute neutrophil count ≥ 1,500/mcL
- •Platelet count ≥ 100,000/mcL
- •Hemoglobin ≥ 9 g/dL
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Aspartate Aminotransferase (AST) ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Troponin-T normal
- •Left ventricular ejection fraction (LVEF) ≥ 50% by ECHO or MUGA
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Agrees to provide blood and tissue samples for the mandatory translational research component of the study
- •Must be able to avoid direct contact with pregnant or nursing women, infants, and immuno compromised individuals during study and for ≥ 3 weeks following the last dose of study agent
- •No concurrent uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris, cardiac arrhythmia, or myocardial infarction within the past year
- •Psychiatric illness/social situation that would preclude study compliance
- •No known HIV positivity
- •Patients with a clinical history suggestive of an immuno compromised status are required to undergo HIV testing
- •More than 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered
- •More than 2 weeks since prior radiotherapy, immunotherapy, or treatment with small molecule cell cycle inhibitors
- •No other concurrent investigational agents
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Tumor Response
时间窗: Every 4 weeks after 4 courses of treatment, assessed up to 5 years
A tumor response is defined to be a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD.
次要结局
- Time to Disease Progression(Time from registration to documentation of disease progression, assessed up to 5 years)
- Overall Survival(Time from registration to death due to any cause, assessed up to 5 years)