Metastatic Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
Phase II Study Of Lutetium-177 Labeled Chimeric Monoclonal Antibody Girentuximab (177Lu-DOTA-girentuximab) in Patients With Advanced Renal Cell Cancer
To determine the efficacy of multiple doses Lutetium-177-DOTA-girentuximab in patients with advanced clear cell renal cell carcinoma using RECIST criteria.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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