Trial Information

Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Chimeric Monoclonal Antibody cG250 (90Y-DOTA-cG250) in Patients With Advanced Renal Cancer

This is a Phase I dose escalation study using 90Y-DOTA-cG250 for treatment of patients with
advanced kidney carcinoma. The initial group of patients will be treated with 0.2 mCi/Kg of
yttrium-90. Subsequent treatments will be in 0.1 mCi/Kg increments, with the last cohort
increasing by 0.05 mCi/Kg. At least three patients per dose level will be followed for up to
8 weeks (or after recovery from toxicity) with imaging, biochemical, serological, and
hematologic tests for toxicity. CT scans will be carried out at baseline and after 6-8 weeks
(or after recovery from toxicity).

Patients will initially receive 5 mCi/10 mg 111In-DOTA-cG250 antibody (an imaging dose).
Whole body and blood measurements of radioactivity will be obtained on at least three
occasions for one week to determine targeting and dosimetry. Therapeutic 90Y-DOTA-cG250 will
be administered the following week, if there is evidence of In-111 cG250 targeting to
lesions > 2 cm detected on CT. Patients will be treated as outpatients and will receive only
one treatment.