Trials / Completed
CompletedNCT00049023
Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (actual)
- Sponsor
- O'Dorisio, M S · Academic / Other
- Sex
- All
- Age
- 2 Years – 25 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Brain and Central Nervous System Tumors
- Gastrointestinal Carcinoid Tumor
- Islet Cell Tumor
- Neuroblastoma
- Pheochromocytoma
- Sarcoma
- Unspecified Childhood Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | 90Y-DOTA-tyr3-OCTREOTIDE |
Timeline
- Start date
- 2002-01-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2003-01-27
- Last updated
- 2016-06-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00049023. Inclusion in this directory is not an endorsement.