Phase II Study of Lutetium-177 Labeled Girentuximab in Patients With Advanced Renal Cancer
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|ClinicalTrials.gov Identifier: NCT02002312|
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : August 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Clear Cell Renal Cell Carcinoma||Drug: Lu-177-DOTA-girentuximab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Of Lutetium-177 Labeled Chimeric Monoclonal Antibody Girentuximab (177Lu-DOTA-girentuximab) in Patients With Advanced Renal Cell Cancer|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Patients in receive 10 mg of girentuximab coupled to DOTA and labeled with 65 mCi/m2 of Lu-177 if targeting of In-111-DOTA-girentuximab is observed in at least 1 lesion. 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.
Drug: In-111-DOTA-girentuximab At day 1, every patient received girentuximab at a dose of 10 mg coupled to DOTA and labeled with 5 mCi of In-111.
Drug: Lu-177-DOTA-girentuximab At day 8-10, every patient receives girentuximab at a dose of 10 mg coupled to DOTA and labeled with 65 mCi/m2 of Lu-177. If eligible, patients are retreated at a dose 75% of the previous dose, for a total of not more than three treatments.
Other Name: Lu-177-DOTA-cG250
- Tumor response [ Time Frame: 12 weeks ]Evaluation according to RECIST criteria
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002312
|Radboud University Medical Center|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||W. J. Oyen, MD, PhD||Department of Nuclear Medicine, Radboud University Medical Center Nijmegen|
|Principal Investigator:||P. F. Mulders, MD, PhD||Department of Urology, Radboud University Medical Center Nijmegen|