EUCTR2008-002130-30-DE进行中（未招募）1 期
Targeted Natural Killer (NK) cell based adoptive immunotherapy for the treatment of patients with Non-Small Cell Lung Cancer (NSCLC) after radiochemotherapy (RCT)
Technische Universität München Fakultät für Medizin0 个研究点目标入组 90 人开始时间: 2008年6月9日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •1.First diagnose of histologically and/or cytologically proven and unresectable NSCLC with clinically stage III A and III B
- •2.Completion of radiochemotherapy no longer than 8 weeks ago
- •3.Progression free according to RECIST 1.1 criteria at the first assessment after completion of radiochemotherapy
- •4.Confirmed presence of Hsp70 on patient´s tumors
- •5.Female or male, age 18 to 75 years
- •6.ECOG Status = 2
- •7.Neutrophil count = 1.5 x 109/l after completion of radiochemotherapy
- •8.WBC = 2.5 x 109/l after completion of radiochemotherapy
- •9.Haemoglobin >8g/l after completion of radiochemotherapy
- •10.Platelet count = 100 x 109/l after completion of radiochemotherapy
- •11.Normal renal function (creatinine <150% ULN)
- •12.Normal liver function (Bilirubin <200% ULN; G-GT, GPT und GOT <250% ULN;)
- •13.Normal blood coagulation (PTT 25-40s)
- •14.Measurable disease according to irRC criteria
- •15.Female patients of childbearing potential must have negative pregnancy test performed during screening period (= 14 days before initiation of study drug dosing). Postmenopausal women must be amenorrheal for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for 6 months following discontinuation of study drug.
- •16.Written (signed) Informed Consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment and to participate in the study
- •17.Ability to comply with study and follow-up procedures
- •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 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prior treatment with any other investigational drug within 4 weeks prior to first dose of study medication
- •2.Any severe heart disease or any severe concomitant disease (ECOG stage > 2)
- •3.NSCLC patients (stage IIIA/B) eligible for initial surgery with a confirmed consent of an interdiscipliary Tumorboard
- •4.Patients that show ALK positivity or an activating mutation of the EGFR-TK domain
- •5.Patients with locally advanced or metastastic non-small cell lung cancer other than predominantly squamous cell histology
- •6.Any disease (including psychotic disorders, drug abuse, active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding likely (in the investigator’s opinion) to affect the evaluation of the study or place the patient at risk whilst on treatment
- •7.Any serious infection or sepsis
- •8.Any active autoimmune disease
- •9.Any immunodeficiency syndrome
- •10.Surgery or immunotherapy within 4 weeks before study entry
- •11.Patients with known hypersensitivity to any of the administered substances should be excluded from the clinical trial
- •12.Patients with a positive HIV test should be excluded from the clinical trial as well as patients with positive Hepatitis A, B, C tests
- •13.Receipt of immunosuppressive drugs including high dose systemic corticosteroids within 3 weeks before study entry. Low dose corticosteroids as they are a common treatment option for patients suffering from COPD are not an exclusion criterium.
- •14.Radio-, cytostatic-, and immuno-therapy in parallel or within 4 weeks prior to study start
- •15.Women who are pregnant or breast feeding
- •16.Female patients of reproductive potential unwilling to practice a highly effective method of birth control
- •17.History of noncompliance with medical regimens
- •18.Patients unwilling to or unable to comply with the protocol
研究者
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