DRKS00000249已完成1 期

Phase I study of a gene modified, B7/IL-2 transfected allogeneic tumor cell vaccine for the treatment of metastatic renal cell carcinoma

udwig-Maximilians-Universität MünchenLabor für Tumorimmunologie, LIFE-Zentrum0 个研究点目标入组 15 人开始时间: 2011年11月10日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Histologically proven metastatic renal cell carcinoma (stage IV Holland/Robson)
•- Patients must be HLA-A*0201
•- ECOG 0-1
•- Life expectancy > 3 months
•- Age > 18 y. and < 75y.
•- Interval between the last therapy course and enrollment in the study should be at least 3 months
•- Interval between surgery and enrollment in the study should be at least 4 weeks
•- At least one evaluable marker lesion other than bone or brain metastases should be present
•- Written informed consent

•- Pregnancy or nursing
•- Anamnestic, clinical or laboratory evidence of active autoimmune disease
•- History of severe allergy
•- Systemic corticosteroid therapy or other immunosuppressive therapy
•- Patients with organ allografts
•- HIV positivity
•- Active systemic infection or other major medical illness, including severe heart disease, severe respiratory diseases or nervous system disorders.
•- Active brain metastatic lesions
•- Serum creatinine > 2.5 mg /dl
•- Bilirubin > 3.0 mg /dl, Transaminases > 100 U/L
•- WBC < 2500 / mm^3, hemoglobin < 7.5 g /dl or platelets < 100.000 / mm^3
•- Evidence or history of other malignant tumor in the previous 5 years
•- Use of unapproved biologic agents such as mistletoe extracts, live cells, live-cell extracts or other immune activating agents.

发起方

udwig-Maximilians-Universität MünchenLabor für Tumorimmunologie, LIFE-Zentrum