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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study Of Lutetium-177 Labeled Chimeric Monoclonal Antibody Girentuximab (177Lu-DOTA-girentuximab) in Patients With Advanced Renal Cell Cancer

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

Detailed Summary:

This is a Phase II study using Lu-177-DOTA-girentuximab for treatment of patients with advanced clear cell renal cell carcinoma. The trial requires 14 patients. CT scans will be carried out at baseline and after 12 weeks, for response assessment using RECIST criteria.

Patients will initially receive 5 mCi/10 mg Indium-111-DOTA-girentuximab antibody (an imaging dose preceeding Lu-177-girentuximab treatment). Whole body and blood measurements of radioactivity will be obtained on at least three occasions for one week to determine targeting and dosimetry. Only if at least one known and evaluable metastatic lesion is visualized with In-111-DOTA-girentuximab, therapeutic Lu-177-DOTA- girentuximab will be administered the following week. In the absence of disease progression and after recovery from toxicity, patients may be retreated no sooner than 12 weeks after the prior treatment with a dose of no more than 75% of the previous dose, for a total of not more than three treatments. Only patients who have normal pharmacokinetics on the preceding diagnostic In-111-girentuximab study (indicative of human antichimeric antibodies (HACA) negativity) are eligible for retreatment.


Sponsor: Radboud University

Current Primary Outcome: Tumor response [ Time Frame: 12 weeks ]

Evaluation according to RECIST criteria


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression free survival [ Time Frame: 3 years ]
    Progression free survival is defined as the time measured from the day of first administration of Lu-177-girentuximab to first progression or death, whichever comes first.
  • Toxicity [ Time Frame: up to 14 weeks after last therapeutic infusion ]
    Toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v3.0)


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: November 29, 2013
Date Started: August 2011
Date Completion:
Last Updated: August 12, 2015
Last Verified: August 2015