Clinical Trial · NCT00142415

Phase I/II Dose-escalation Study of Lutetium-177-labeled cG250 in Patients With Advanced Renal Cancer

Overview

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.

Sponsor

Olivia Newton-John Cancer Research Institute

Phase

Phase 1/2

Contacts

W.J.G. Oyen, MD (PRINCIPAL_INVESTIGATOR)

P.F.A. Mulders, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00142415

Drug / Compound

cG250

Isotope(s):

Target(s):

CAIX

Ligand Class: Antibodies

Chelator: DOTA

cG250

Isotope(s):

Target(s):

CAIX

Ligand Class: Antibodies

Chelator: DOTA

Eligibility

Inclusion

Negative pregnancy test for women of childbearing potential (urine or serum).
At least one evaluable lesion \< 5 cm.
Subjects with proven advanced and progressive renal cell carcinoma (RCC) of the clear cell type.
Serum creatinine ≤ 2 × ULN
Platelet count ≥ 100 × 10\^9/L

Exclusion

Metastatic disease limited to the bone.
Chemotherapy, external beam radiation or immunotherapy within 4 weeks prior to study. Limited field external beam radiotherapy to prevent pathological fractures was allowed, when unirradiated, evaluable lesions were present elsewhere.
Known metastases to the brain.