NCT00087373终止2 期
Phase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Local response defined as complete response (CR), a partial response (PR) stable disease (SD), or progressive disease (PD) in the injected lesion according to RECIST criteria
研究概览
简要总结
Vaccines may make the body build an immune response to kill tumor cells. Injecting a vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.
详细描述
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of intratumoral fowlpox-TRICOM in patients with metastatic melanoma.
II. Determine the local response rate in patients treated with this agent. III. Determine systemic clinical response in patients treated with this agent.
SECONDARY OBJECTIVES:
I. Determine the increase in transgene expression of B7-1, leukocyte function-associated antigen-3 (LFA-3), and intercellular adhesion molecule-1 (ICAM-1) in patients treated with this agent.
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 melanoma
- •Stage IV disease
- •Measurable disease
- •At least 1 cutaneous or lymph node mass ≥ 1 cm AND amenable to biopsy and percutaneous injection AND can be accurately measured with standard calipers
- •Must be tested for expression of HLA-A2 prior to study
- •Must have 1 of the following criteria:
- •Circulating melanoma-specific CD8-positive T cells against ≥ 1 defined antigen (Melan-A, gp100 antigen, tyrosinase, MAGE-A10, Trp-2, or NA17) as measured by tetramer or ELISpot directly ex-vivo or after a 10 day in vitro expansion
- •Detectable intratumoral T cells measured in the index lesion that is to be injected with rF-TRICOMTM by immunohistochemistry (IHC) for CD4, CD8 or another T cell marker, or by real time RT-PCR for CD8a, CD4, or other T cell transcripts
- •No untreated or edematous brain metastases or leptomeningeal disease
- •Treated CNS disease allowed provided patient remains stable off corticosteroid therapy
- •Performance status - Karnofsky 70-100%
- •More than 12 weeks
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No uncontrolled bleeding disorder that would increase the risk of bleeding from the injected lesion
- •No active thrombotic thrombocytopenic purpura within the past 2 years
- •PT/PTT ≤ 1.25 times upper limit of normal (ULN)
- •AST and ALT ≤ 1.5 times ULN
- •Bilirubin ≤ 1.5 times ULN
- •No chronic hepatitis B or C
- •Creatinine ≤ 2.0 mg/dL
- •Creatinine clearance ≥ 60 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •HIV negative
- •No prior significant allergic reaction or hypersensitivity to eggs or egg products
- •No disease that limits the function of the spleen (e.g., sickle cell disease)
- •No uncontrolled active or chronic infection
- •No active autoimmune disorders or disease
- •No immunosuppression, defined as concurrent or possible requirement for systemic corticosteroids
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 4 weeks after study participation
- •Able to avoid direct contact of the immunization site with the following individuals:
- •Children < 3 years of age
- •Immunocompromised individuals (including those on systemic corticosteroids)
- •Pregnant women
- •Individuals with extensive skin disease
- •No active seizure disorder
- •No skin disease and/or open unhealing wounds
- •No psychiatric illness or social situation that would preclude study compliance
- •No other significant medical illness that would significantly increase the risk associated with immunotherapy
- •No other active malignancy requiring concurrent therapy except squamous cell or basal cell skin cancer or undetectable hormone-responsive prostate cancer (as measured by normal prostate-specific antigen)
- •No other concurrent uncontrolled illness that would preclude study participation
- •No prior fowlpox virus-based therapy
- •No prior B7-1, intercellular adhesion molecule-1 (ICAM-1), or leukocyte function-associated antigen-3 (LFA-3)
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •See Disease Characteristics
- •Concurrent adjuvant hormonal therapy for early-stage or high-risk breast cancer allowed
- 另有 8 项未显示
排除标准
- 未提供
结局指标
主要结局
Local response defined as complete response (CR), a partial response (PR) stable disease (SD), or progressive disease (PD) in the injected lesion according to RECIST criteria
时间窗: Up to 15 years
Overall clinical response (CR or PR) as measured by RECIST criteria
时间窗: Up to 15 years
次要结局
- Time to tumor progression(Up to 15 years)
- Change in mRNA expression of B7-1, LFA-3, and/or ICAM-1in the tumor microenvironment(Baseline and week 10)
- Changes in tumor associated T cells(Baseline and week 10)
研究者
研究点 (2)
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