Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006370
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2000-10-04
Brief Title:
Radiolabeled SMT-487 Yttrium Y 90-DOTA-tyr3-octreotide in Treating Patients With Refractory Small Cell Lung Cancer or Metastatic Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Open-label Multi-Center Study to Evaluate the Efficacy of 90Y-SMT 487 Administered Intravenously to Patients With Refractory Small Cell Lung or Advanced Metastatic Breast Cancer Expressing Somatostatin Receptors as Determined by OctreoScan Scintigraphy
Status:
COMPLETED
Status Verified Date:
2013-04
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 drugs such as yttrium Y 90-DOTA-tyr3-octreotide can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase II trial to study the effectiveness of yttrium Y 90-DOTA-tyr3-octreotide in treating patients who have refractory small cell lung cancer or metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of yttrium Y 90-DOTA-tyr3-octreotide in treating patients who have refractory small cell lung cancer or metastatic breast cancer
Detailed Description:
OBJECTIVES I Determine the tumor response rate of yttrium Y 90 SMT 487 in patients with refractory small cell lung cancer or advanced metastatic breast cancer expressing somatostatin receptor II Determine the safety of this treatment regimen in these patients III Determine the overall survival of these patients with this treatment regimen IV Determine the quality of life in these patients with this treatment regimen V Determine the frequency of tumors which are positive 3 or 4 for OctreoScan scintigraphy in this patient population
OUTLINE This is a multicenter study Patients receive yttrium Y 90 SMT 487 IV over 10-15 minutes on day 1 Treatment repeats every 6-9 weeks for up to 3 courses in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline and at course 3 week 6 Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A total of 10-29 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive yttrium Y 90 SMT 487 IV over 10-15 minutes on day 1 Treatment repeats every 6-9 weeks for up to 3 courses in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline and at course 3 week 6 Patients are followed at 6 and 12 months
PROJECTED ACCRUAL A total of 10-29 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-G00-1858 | Registry Identifier | PDQ Physician Data Query | None |
| MCC-12338 | None | None | None |
| MCC-IRB-5803 | None | None | None |
| CDR0000068243 | REGISTRY | None | None |