Patients with metastatic clear cell renal cell carcinoma MedDRA version: 9.1 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Interventions
Product Name: cG250
Product Code: cG250
Pharmaceutical Form: Solution for infusion
Sponsors
Radboud university nijmegen medical centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the clinical efficacy of multiple doses of 177Lu-DOTA-cG250 at MTD in patients with advanced renal cancer using RECIST criteria;Secondary Objective: To determine the toxicity of the treatment as defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v3.0) To determine the targeting and dosimetry of 111In-DOTA-cG250 in patients with advanced renal cancer, as a surrogate for 177Lu-DOTA-cG250 ;Primary end point(s): After all 9 patients have finished the study (up to three treatment cycles) the efficacy of the treatment will be determined. | — |
Countries
Netherlands
Outcome results
None listed