Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
Recruitment status was Recruiting
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 studying the effectiveness of radiolabeled octreotide in treating children who have advanced or refractory solid tumors.
Brain and Central Nervous System Tumors
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Unspecified Childhood Solid Tumor, Protocol Specific
Radiation: yttrium Y 90-edotreotide
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I, Open Label, Maximum Tolerated Dose-Finding Study to Evaluate the Safety and Tolerability of 90Y-DOTA-tyr3-Octreotide Administered by Intravenous Infusion to Children With Refractory Somatostatin-Receptor Positive Tumors|
|Study Start Date:||January 2002|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049023
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242-1002|
|Contact: Cancer Information Service 800-237-1225|
|Study Chair:||M. Sue O'Dorisio, MD, PhD||Holden Comprehensive Cancer Center|