EUCTR2016-001454-18-DK进行中（未招募）1 期
T cell therapy for patients with advanced Renal Cell Carcinoma
Center for Cancer Immune Therapy0 个研究点目标入组 6 人开始时间: 2016年7月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
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. Histological proven mRCC with the possibility of surgical removal of tumor tissue of > 1 cm3. Histology must include a clear cell component with or without a sarcomatoid dedifferentiation.
- •2. Metastatic disease irrespective of number of previous treatment lines. Treatment naïve pt’s can be included.
- •3. Age: 18 – 70 years.
- •4. ECOG performance status of =1.
- •5. IMDC prognostic group ‘Favorable’ or ‘Intermediary’
- •6. Life expectancy of > 6 months.
- •7. At least one measurable parameter after surgery in accordance with RECIST 1.1 –criteria’s.
- •8. No significant toxicities or side effects (CTC = 1) from previous treatments.
- •9. Normal ejection fraction (EF) measured by a multigated acquisition (MUGA) scan.
- •10. Crom EDTA clearance >40 ml/min
- •11. Sufficient organ function.
- •12. LDH = 5 times upper normal limit as a measure of tumor burden
- •13. Women in the fertile age must use effective contraception. Likewise, men included in the study, as well as their partners, must use effective contraception. This applies from inclusion and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered safe contraceptives.
- •14. Signed statement of consent after receiving oral and written study information. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research
- •15. Willingness to participate in the planned controls.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. A history of prior malignancies, exept curatively treated non-melanoma skin cancer and CIS of the cervix uteri. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 3 years after treatment.
- •2. Patients with cerebral metastases.
- •3. Patients with widespread bone or bone only metastases.
- •4. Known hypersensitivity to one of the active drugs or one or more of the excipients.
- •5. Severe medical conditions, such as severe asthma/COLD, ischemic hearth disease/significant cardiac disease (e.g. NYHA class =2), poorly regulated insulin dependent diabetes mellitus among others, which can interfere with patient compliance and/or significantly increase the risk of side effects upon investigators clinical judgement.
- •6. Acutte/chronic infection with HIV, hepatitis, tuberculosis among others.
- •7. Severe allergies or previous anaphylactic reactions.
- •8. Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosis, Sjögren’s syndrome, sclerodermia, myasthenia gravis, Goodpasteur’s disease, Addison’s disease, Hashimotos thyroiditis, active Graves disease.
- •9. Pregnant women and women breastfeeding.
- •10. Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, methotrexate among others).
- •11. Simultaneous treatment with other experimental drugs.
- •12. Simultaneous treatment with other systemic anti-cancer treatments.
- •13. Patients with active and uncontrollable hypercalcaemia.
研究者
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