T cell therapy for patients with advanced Ovarian Cancer

Center for Cancer Immune Therapy0 个研究点开始时间: 2015年4月9日最近更新: 2017年5月22日

适应症

试验速览

暂无简介。

•1. Histological proven advanced ovarian cancer with the possibility of surgical removal of tumor tissue of > 1 cm3. Histology must be high grade serous carcinoma.
•2. Progressive or recurrent resistant disease after platin-based chemotherapy or progressive or recurrent disease after second line or additional chemotherapy
•3. Age: 18 – 70 years
•4. ECOG performance status of =1
•5. Life expectancy of > 6 months
•6. At least one measurable parameter in accordance with RECIST 1.1 –criteria’s
•7. No significant toxicities or side effects (CTC = 1) from possible previous treatments, except sensoric- and motoric neuropathy (CTC = 2) and/or alopecia (CTC = 2).
•8. Sufficient organ function.
•9. Women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment.
•10. Signed statement of consent after receiving oral and written study information
•11. Willingness to participate in the planned controls and capable of handling toxicities.
•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

•1. Patients with other cancers within 5 years.
•2. Known hypersensitivity to one of the active drugs or one or more of the excipients.
•3. Serious comorbidity or autoimmune disease.
•4. Creatinine clearence < 70 ml/min (in selected cases it can be decided to include patients with a lower GFR with the use of a reduced dose of chemotherapy).
•5. Acutte/chronic infection with HIV, hepatitis, tuberculosis among others.
•6. Severe allergies or previous anaphylactic reactions.
•7. Pregnant women and women breastfeeding.
•8. Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone, metothrexate among others).
•9. Simultaneous treatment with other experimental drugs.
•10. Simultaneous treatment with other systemic anti-cancer treatments.
•11. Patients with active and uncontrollable hypercalcaemia.

发起方

Center for Cancer Immune Therapy