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

Phase 2

Completed

• Conditions: Metastatic Clear Cell Renal Cell Carcinoma
• Interventions: Drug: Lu-177-DOTA-girentuximab

• Registration Number: NCT02002312
• Lead Sponsor: Radboud University Medical Center

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 Description

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-11-29
• Study First Submitted QC: 2013-11-29
• Study First Posted: 2013-12-05
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu-177-DOTA-girentuximab	Lu-177-DOTA-girentuximab	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.

Primary Outcome Measures

Name	Time	Method
Tumor response	12 weeks	Evaluation according to RECIST criteria

Secondary Outcome Measures

Name	Time	Method
Progression free survival	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	up to 14 weeks after last therapeutic infusion	Toxicity defined by NCI Common Terminology Criteria for Adverse Events (CTCAE v3.0)

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands