Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049023
Status:
COMPLETED
Last Update Posted:
2016-06-21
First Post:
2002-11-12
Brief Title:
Radiolabeled Octreotide in Treating Children With Advanced or Refractory Solid Tumors
Sponsor:
ODorisio M S
Organization:
University of Iowa
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V02-1710 | None | None | None |
| UIHC-200008086 | None | None | None |