Phase I/II Study of Increasing Doses of Lutetium-177 Labeled Chimeric Monoclonal Antibody cG250 in Patients With Advanced Renal Cancer
This is a Phase I/II dose escalation study using 177Lu-DOTA-cG250 for treatment of patients
with advanced renal cell carcinoma. The trial requires a minimum of 6 patients and a maximum
of 18 patients. The initial group of patients will be treated with 30 mCi/m2 of Lu-177.
Subsequent treatments will be in 10 mCi/m2 increments. At least three patients per dose
level will be followed for up to 12 weeks with imaging, biochemical and hematologic tests to
determine the safety of 177Lu-DOTA-cG250. CT scans will be carried out at baseline and
after 12 weeks (or after recovery from toxicity), for response assessment.
Patients will initially receive 5 mCi/10 mg 111In-DOTA-cG250 antibody (an imaging dose
preceeding Lu-177-cG250 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-cG250,
therapeutic 177Lu-DOTA-cG250 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-cG250 study (indicative of HACA
negativity) are eligible for retreatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety of increasing doses of 177Lu-DOTA-cG250 in patients with advanced renal cancer to establish the MTD
W.J.G. Oyen, MD, PhD
Department of Nuclear Medicine, University Medical Center Nijmegen
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)