RATIONALE: Radiolabeled octreotide can locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. PURPOSE: This phase I trial is to study the safety and effectiveness of radiolabeled octreotide in treating children who have advanced or refractory solid tumors.
OBJECTIVES: * Determine the maximum tolerated dose of yttrium Y 90-DOTA-tyr3-octreotide in children with advanced or refractory somatostatin receptor-positive tumors. * Determine the short-term and long-term safety and the serious adverse-event profiles of this drug in these patients. * Determine any potential antitumor effect of this drug in these patients. * Correlate level of somatostatin receptor type 2 expression with response in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive yttrium Y 90-DOTA-tyr3-octreotide IV over 5-10 minutes on day 1. Treatment repeats every 6 weeks for up to 3 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of yttrium Y 90-DOTA-tyr3-octreotide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly after each treatment course, 6 weeks after the last course, and then every 6 months thereafter for life. PROJECTED ACCRUAL: Approximately 25-35 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Establish the three-cycle maximum-tolerated dose of 90Y-DOTA-tyr3-Octreotide
Establish the three-cycle maximum-tolerated dose of 90Y-DOTA-tyr3-Octreotide administered by intravenous infusion to children with refractory somatostatin-receptor positive tumors based upon the 6 week/cycle dose-limiting-toxicity profile.
Time frame: 6 weeks per cycle
Evaluate the short term and long term safety (mild/moderate/severe/life-threatening adverse events, premature discontinuations and serious adverse events)
2\. Evaluate the short-term (6 weeks/cycle) and long term (4-6 months) safety (mild/moderate/severe/life-threatening adverse events, premature discontinuations and serious adverse events) serious adverse event profile of three-cycles of 90Y-DOTA-tyr3-Octreotide administered by intravenous infusion to children with refractory somatostatin-receptor positive tumors.
Time frame: short term (6 weeks/cycle); long term (4-6 mos./cycle)
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