EUCTR2010-023277-19-AT进行中（未招募）不适用
CD20-Immunotargeting in Stage IV Melanoma Patients- A Prospective, Open Label, Two-Period Pilot Study to Evaluate Overall Tumor Responsive Rate - CD20-Immunotargeting
Med. Univ. Wien, Univ. Klinik für Dermatologie0 个研究点目标入组 49 人开始时间: 2011年4月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Signed informed consent prior to any study-mandated procedure.
- •Metastatic non-ocular melanoma (clinical stage IV)
- •measurable disease with more than one metastatic lesion
- •One of these metastases must be resectable prior to anti-CD20 therapy. ECOG performance status of 0-2.
- •As soon as BRAF inhibitors are standard of care, we will include only patients with tumors containing BRAF wildtype.
- •Negative pregnancy test in female patients of childbearing potential and adequate contraception in female patients of childbearing age.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with active brain metastasis and Ig-deficiency will be excluded.
- •Subjects meeting any of the following criteria must not be enrolled in an ofatumumab study:
- •Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- •Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
- •Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
- •Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
- •History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
- •HIV positive
- •Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
- •Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.
- •Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
- •Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result
- •Screening laboratory values:
- •platelets <70 x 109/L
- •leukocytes <1.5 x 109/L
- •creatinine >2.0 times upper normal limit
- •total bilirubin >1.5 times upper normal limit
- •ALT >2.5 times upper normal limit
- •alkaline phosphatase >2.5 times upper normal limit
- •Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening.
- •Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence.
- •Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
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