Clinical Study of OncoSorb® in Patients With Advanced Cancer Entities
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 11
- 主要终点
- Occurrence of: possible catheter infection, suitability of citrate/heparin anticoagulation, adverse events/serious adverse events in general
研究概览
简要总结
The purpose of this study is to collect further data for safety and feasibility for the use of the medical device OncoSorb® in clinical routine for the treatment of patients with solid metastatic cancer entities who have failed standard therapies. OncoSorb® device is intended to specifically adsorb three soluble receptors (sTNF-R1, sTNF-R2 and sIL-2R α), which are known to inhibit the natural immune response of cancer patients mediated via tumor necrosis factor α (TNF- α).
详细描述
STUDY PURPOSE: The purpose of this study is to collect further data for safety and feasibility for the use of the medical device OncoSorb® in clinical routine for the treatment of patients with solid metastatic cancer entities who have failed standard therapies.
MEDICAL DEVICE: The medical device used in this clinical study is the OncoSorb® column. It is used with a specially modified Fresenius ART apheresis machine, associated tubing sets and an Albuflow plasma filter, also from Fresenius. These components comprise the extracorporeal immune apheresis system. The OncoSorb® column was CE certified in April 2008. The OncoSorb® device is intended to specifically adsorb three soluble receptors (sTNF-R1, sTNF-R2 and sIL-2R α), which are known to inhibit the natural immune response of cancer patients mediated via tumor necrosis factor α (TNF- α).
OBJECTIVES: Primary objective:
The primary objective is to evaluate the use of OncoSorb® therapy in clinical practice in terms of both safety and feasibility. This involves the evaluation of system-immanent issues (particularly occurrence of possible catheter infections and suitability of citrate/heparin anticoagulation) during the course of the clinical study prior the initiation of a phase II study.
Primary variables:
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 metastatic solid cancer who have documented progressive disease and who have failed standard therapy
- •Measurable disease (RECIST criteria)
- •Expected survival of at least 4 months
- •Performance status ECOG 0 and 1
- •Vital laboratory parameters within normal range, or protocol specified ranges
- •Able to give written informed consent
- •The patient's sTNF-R1, sTNF-R2 levels in citrate plasma are > 500 pg/ml and > 1000 pg/ml respectively
- •The patient has adequate renal function as evidenced by glomerular filtration rate > 80 ml/min
- •Patient 5 with metastatic melanoma must have skin lesion(s)
- •Patient 5 with metastatic melanoma should have slow tumor progression
- •Patient 5 with metastatic melanoma must have an intact TNF-receptor signaling cascade, resulting in measurable induction of cancer cell apoptosis following the exposition to TNF-α in vitro. This will be evidenced by destruction of primary autologous cancer cells obtained by biopsy.
排除标准
- •Other serious or significant illnesses
- •Other malignancy within the last 3 years, except for target oncological indication (does not exclude metastatic sites)
- •Known immunodeficiency
- •Known HIV or hepatitis positivity
- •Using systemic immunosuppressive drugs. (Exceptions: Specific COX-2 inhibitors; low dose aspirin for cardiovascular event prevention; topical/inhaled steroids)
- •Chemotherapy, immunotherapy or radiotherapy within two weeks prior to start of OncoSorb® treatments provided that all prior therapy related toxicities are resolved
- •Participation in a prior clinical trial involving an investigational agent within the last 2 weeks
- •Not available for clinical follow-up assessments
- •Pregnancy or breastfeeding
- •Refusal or inability to use effective means of contraception for women of childbearing potential
- •Mental impairment that may compromise ability to give informed consent and to comply with study requirements
- •History of a myocardial infarction within 6 months prior to the start of study, uncontrolled congestive heart failure, or any current Grade 3 or 4 cardiovascular disorder despite treatment
- •Coagulation disorders and / or a history of thromboembolic complications
- •Any significant disease that, in the Investigator's opinion, should exclude the patient from the study
- •Known hypersensitivity or allergy to rabbit proteins
- •Known hypersensitivity to heparin or citrate
- •The patient receives Angiotensin-Converting Enzyme (ACE) inhibitors or Coumadin (Marcumar®) as concomitant medication
- •Patient 5 with metastatic melanoma with brain metastases (MRT scan)
- •Patient 5 with metastatic melanoma is severely immunocompromised (patient must have average or low TREG counts, no dysfunctional T cells like e.g. CD28-)
结局指标
主要结局
Occurrence of: possible catheter infection, suitability of citrate/heparin anticoagulation, adverse events/serious adverse events in general
时间窗: 0-6 months
次要结局
- Overall response defined by RECIST criteria(8 week response rate)
- Quality of life questionaire (as assessed by EORTC QLQ-C30 rev. 3.0)(0-6 months)
- Kinetics of sTNF-R1, sTNF-R2 and sIL-2R α(receptor levels will be measured on treatment day 4)