Treatment of metastatic renal cell carcinoma using interleukin-12 secreting dendritic cells. Phase I/II clinical trial.

Masaryk University0 个研究点目标入组 30 人开始时间: 2011年9月14日最近更新: 2016年11月14日

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•Male and female patients, aged between 18-80 years.
•Eligible for TKI treatment with Sunitinib or Sorafenib according the doctor's instructions.
•The patients must undergo nephrectomy or nephron-sparing surgery or metastasectomy.
•At least one measurable lesion at baseline as per the RECIST criteria, determined by CT scan or MRI.
•ECOG performance status 0-1.
•Histologically confirmed clear cell mRCC after surgery is necessary.
•Written informed consent obtained prior to study entry.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•Pregnancy or nursing.
•Prior immune suppressive therapy (less than 4 week before screening).
•Evidence of an active infectious disease or active autoimmune disease.
•Other malignancies within the last 5 years.
•Renal insufficiency requiring haemodialysis.
•Impaired renal function (serum creatinine >2.0 times upper limit of normal (ULN).
•Impaired hepatic function (ALT or AST >2.5 times ULN).
•At least two out of three positive risk factors (modified from Molina et al.):
•Lactate dehydrogenase >1.5 times ULN;
•Serum calcium >2.5 mmol/l
•Haemoglobin < 120 g/l (in women), < 130 g/l (in men).
•Impaired haematological parameters, including WBC < 4x109/l, haemoglobin < 100 g/l, or platelet count <100x109/l.
•History of significant cardiovascular disease (myocardial infarct <3 months, unstable angina, NYHA (New York Heart Assotiation) class II-IV, serious cardiac arrhythmia requiring medication).
•Untreated hypertension (systolic >180 mm Hg and/or diastolic >100 mm Hg).
•Sero-positivity for HIV1, 2, Treponema pallidium or active Hepatitis B or C infection.

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