A Phase I, Open-Label, Maximum Tolerated Single-Cycle and Four-Cycle Dose-Finding Study to Evaluation the Safety and Tolerability of 90Y-SMT 487 Administered by Intravenous Infusion to Subjects With Refractory Somatostatin-Receptor Positive Tumors
OBJECTIVES: I. Determine the maximum tolerated dose of yttrium Y 90-SMT 487 in patients with
recurrent malignant neoplasms that prove positive for somatostatin receptors. II. Determine
the safety and lifetime serious adverse event profile of this regimen in these patients. II.
Determine the antitumor effect and the effect of repeated administrations on the renal
excretion pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study. Patients undergo octreotide
scintigraphy to determine the location of somatostatin receptors. Patients then receive
yttrium Y 90-SMT 487 IV over 15 minutes on day 1. Treatment continues every 6 weeks for up
to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients each are entered on course I (vertical dose escalation) and courses II, III, and IV
(horizontal dose escalation). Cohorts receive escalating doses of yttrium Y 90-SMT 487 until
the maximum tolerated dose (MTD) is determined. MTDs are determined for a single course and
for 4 courses. The MTD is defined as the dose preceding that at which no more than 2 of 6
patients experience dose limiting toxicities. Results of course I determine the dosage of
subsequent courses. Patients are evaluated on days 2 and 7, and at weeks 4 and 6, following
each injection of yttrium Y 90-SMT 487. Patients are followed at 12 and 18 months and then
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Primary Purpose: Treatment
Larry K. Kvols, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
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