NCT01416844撤回2 期
Phase II Exploratory Study of Immune Responses in Patients With Metastatic Melanoma Treated With Mouse Monoclonal Anti-OX40
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Increased number of tumor antigen specific circulating T Cells
研究概览
简要总结
In this study, anti-OX40 will be given to patients with melanoma to find out how the immune system responds to treatment with anti-OX40. It is hoped that this treatment will cause an immune response against melanoma resulting in tumor regression, but this is not known at this time. Anti-OX40 is a large protein that can help immune cells that fight bacteria, viruses and cancer cells.
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
- •Patients with measurable or evaluable unresectable, stage IV metastatic melanoma. Either histologic or cytologic diagnosis is acceptable.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, or 1 (Appendix A.)
- •Age 18 years or above.
- •Laboratory values (performed within 28 days prior to enrollment) as follows:
- •WBC ≥2000/microliter
- •Absolute lymphocyte count >300/mm3
- •Serum creatinine <1.5 X upper limit of laboratory normal
- •Hgb >8g/dl (patients may be transfused to reach this level)
- •Hct > 24%
- •Platelets >100,000 cells/mm3
- •Total bilirubin <1.5 X upper limit of laboratory normal, unless due to Gilbert's disease
- •AST (SGOT)/ALT (SGPT) <2.5 X upper limit of laboratory normal
- •Alkaline phosphatase <2.5 X upper limit of laboratory normal
- •HIV Negative
- •Hepatitis B surface antigen Negative
- •Hepatitis C antibody Negative
- •Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment. Men must avoid fathering a child while on treatment. This exclusion is required due to the unknown toxicities that anti-OX40 may have on the forming fetus, spermatogenesis or the nursing child. Also, because pregnancy may impair immune function it may limit the treatment efficacy.
- •Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.
- •No active bleeding.
- •No clinical coagulopathy (INR <1.5, PT <16 seconds, PTT < 38 seconds).
- •Anticipated lifespan greater than 12 weeks.
- •Failed at least one prior medical therapy for metastatic melanoma.
排除标准
- •Active infection.
- •History of or active autoimmune disease.
- •Prior mouse monoclonal antibody treatment.
- •Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
- •Need for chronic maintenance oral steroids.
- •Active brain metastatic disease. Treated brain metastases with surgery, gamma-knife radiosurgery and/or whole brain radiation and stable for at least 4 weeks and off steroids are eligible.
- •Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures.
结局指标
主要结局
Increased number of tumor antigen specific circulating T Cells
时间窗: Screening (baseline) and Day 15
T Cells will be harvested by apheresis at baseline and Day 15 following anti-OX40 administration.
次要结局
未报告次要终点
研究者
研究点 (2)
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