At a glance
ClinicalIndex Comparison Record- ✓Advanced and progressive renal cell carcinoma of clear-cell histology
- ✓At least one evaluable lesion <5 cm
- ✓Karnofsky performance status ≥70%
- ✓Age >18 years
- ✕Known brain metastases
- ✕Untreated hypercalcemia
- ✕Metastatic disease limited to bone only
- ✕Prior exposure to murine or chimeric antibody therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Study of Increasing Doses of Lutetium-177 Labeled Chimeric Monoclonal Antibody cG250 (177^Lu-DOTA-cG250) in Patients With Advanced Renal Cancer
In Brief
A Phase 2 clinical trial evaluating 111-In-DOTA-cG250 and 177-Lu-DOTA-cG250 for Metastatic Renal Cell Carcinoma. Completed, enrolled 26 participants across 1 site.
Detailed Summary
This was a Phase I/II, single-center, dose-escalation study. 177-Lutetium-1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid-cG250 (177-Lu-DOTA-cG250) was administered at a starting dose of 30 mCi/m\^2 of 177-Lu (fixed dose of 10 mg cG250) and escalated in increments of 10 mCi/m\^2 of 177-Lu in sequentially enrolled cohorts according to a standard 3 + 3 design until determination of the maximum tolerated dose (MTD). The primary objectives were to determine the safety, targeting, and dosimetry of 177-Lu-DOTA-cG250 in subjects with advanced renal cell carcinoma. The secondary objective was measurement of tumor response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0.
Study Details
Timeline
Interventions
On Day 1, each subject received a single intravenous (IV) infusion of 10 mg of cG250 coupled to DOTA and labeled with 5 mCi of 111-In.
On Day 8, 9, or 10, each subject received a single IV infusion of 10 mg of cG250 coupled to DOTA and labeled with a dose of 177-Lu at a starting dose of 30 mCi/m\^2 in the initial cohort.