Phase II Study of Lutetium-177 Labeled Girentuximab in Patients With Advanced Renal Cancer

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the efficacy of multiple doses Lutetium-177-DOTA-girentuximab in patients with advanced clear cell renal cell carcinoma using RECIST criteria.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid; Antibodies, Monoclonal

Criteria

Inclusion criteria:

• Patients with proven advanced and progressive RCC of the clear cell type

• Presence of RECIST v.1.1 evaluable lesions, all < 5 cm

• Performance status: Karnofsky > 70 %

• Laboratory values: • White blood cells (WBC) > 3.5 x 109/l • Platelet count > 150 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) • MDRD ≥ 40 ml/min

• Negative pregnancy test for women of childbearing potential (urine or serum)

• Age over 18 years

• Written informed consent

Exclusion criteria:

• Known or suspected CNS metastases including leptomeningeal metastases. History or clinical evidence of (CNS) metastases (unless they are previously-treated CNS metastases and patients meet all 3 of the following criteria: are asymptomatic, have had no evidence of active CNS metastases for ≥3 months prior to enrollment, and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days)

• Untreated hypercalcemia

• Chemotherapy, external beam radiation, immunotherapy or angiogenesis inhibitors or mTOR 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 4 months.