TheranosticTrials.org

Clinical Trial · NCT02002312

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

Overview

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

Sponsor

Radboud University Medical Center

Phase

Phase 2

Contacts

W. J. Oyen, MD, PhD (PRINCIPAL_INVESTIGATOR)

P. F. Mulders, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02002312

Drug / Compound

girentuximab

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Antibodies
Chelator: DOTA

girentuximab

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Antibodies
Chelator: DOTA

Eligibility

Inclusion

  • Patients with proven advanced and progressive RCC of the clear cell type
  • 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
  • Presence of RECIST v.1.1 evaluable lesions, all \< 5 cm
  • Performance status: Karnofsky \> 70 %
  • Negative pregnancy test for women of childbearing potential (urine or serum)

Exclusion

  • 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.
  • Patients who are pregnant, nursing or of reproductive potential and are not practicing an effective method of contraception
  • Life expectancy shorter than 4 months.
  • 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
  • Cardiac disease with New York Heart Association classification of III or IV
  • 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)