PHASE II STUDY OF LUTETIUM-177 LABELED CHIMERIC MONOCLONAL ANTIBODY cG250 (177Lu-DOTA-cG250) IN PATIENTS WITH ADVANCED RENAL CANCER - Phase II Lutetium

Radboud university nijmegen medical centre0 个研究点开始时间: 2009年11月30日最近更新: 2012年3月19日

试验速览

暂无简介。

•Patients with proven advanced and progressive renal cell carcinoma of the clear cell type
•At least one evaluable lesion less than 5 cm
•Performance status: Karnofsky > 70 %
•Laboratory values obtained less than 14 days prior to registration:
•White blood cells (WBC) > 3.5 x 109/l
•Platelet count > 100 x 109/l
•Hemoglobin > 6 mmol/l
•Total bilirubin < 2 x upper limit of normal (ULN)
•ASAT, ALAT < 3 x ULN (< 5 x ULN if liver metastases present)
•Serum creatinine < 2 x ULN
•Negative pregnancy test for women of child¬bearing potential (urine or serum)
•Age over 18 years
•Ability to provide written informed consent
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Known metastases to the brain
•Untreated hypercalcemia
•Metastatic disease limited to the bone
•Pre-exposure to murine/chimeric antibody
•Chemotherapy, external beam radiation, immunotherapy or angiogenesis inhibitors within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures is allowed, when unirradiated, evaluable lesions elsewhere are present.
•Cardiac disease with New York Heart Association classification of III or IV
•Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
•Any unrelated illness, e.g. active infection, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator will significantly affect patients’ clinical status
•Life expectancy shorter than 6 months

发起方

Radboud university nijmegen medical centre