Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006368
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2000-10-04
Brief Title:
Yttrium Y 90 SMT 487 in Treating Patients With Refractory or Recurrent Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase I Open-Label Maximum Tolerated Single-Cycle and Four-Cycle Dose-Finding Study to Evaluation the Safety and Tolerability of 90Y-SMT 487 Administered by Intravenous Infusion to Subjects With Refractory Somatostatin-Receptor Positive Tumors
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 SMT 487 can locate tumor cells and deliver tumor-killing substances to them without harming normal cells
PURPOSE Phase I trial to study the effectiveness of yttrium Y 90 SMT 487 in treating patients who have refractory or recurrent cancer
PURPOSE Phase I trial to study the effectiveness of yttrium Y 90 SMT 487 in treating patients who have refractory or recurrent cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of yttrium Y 90-SMT 487 in patients with recurrent malignant neoplasms that prove positive for somatostatin receptors II Determine the safety and lifetime serious adverse event profile of this regimen in these patients II Determine the antitumor effect and the effect of repeated administrations on the renal excretion pharmacokinetics of this regimen in these patients
OUTLINE This is a dose escalation multicenter study Patients undergo octreotide scintigraphy to determine the location of somatostatin receptors Patients then receive yttrium Y 90-SMT 487 IV over 15 minutes on day 1 Treatment continues every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each are entered on course I vertical dose escalation and courses II III and IV horizontal dose escalation Cohorts receive escalating doses of yttrium Y 90-SMT 487 until the maximum tolerated dose MTD is determined MTDs are determined for a single course and for 4 courses The MTD is defined as the dose preceding that at which no more than 2 of 6 patients experience dose limiting toxicities Results of course I determine the dosage of subsequent courses Patients are evaluated on days 2 and 7 and at weeks 4 and 6 following each injection of yttrium Y 90-SMT 487 Patients are followed at 12 and 18 months and then annually thereafter
PROJECTED ACCRUAL Approximately 20 patients will be accrued for this study
OUTLINE This is a dose escalation multicenter study Patients undergo octreotide scintigraphy to determine the location of somatostatin receptors Patients then receive yttrium Y 90-SMT 487 IV over 15 minutes on day 1 Treatment continues every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients each are entered on course I vertical dose escalation and courses II III and IV horizontal dose escalation Cohorts receive escalating doses of yttrium Y 90-SMT 487 until the maximum tolerated dose MTD is determined MTDs are determined for a single course and for 4 courses The MTD is defined as the dose preceding that at which no more than 2 of 6 patients experience dose limiting toxicities Results of course I determine the dosage of subsequent courses Patients are evaluated on days 2 and 7 and at weeks 4 and 6 following each injection of yttrium Y 90-SMT 487 Patients are followed at 12 and 18 months and then annually thereafter
PROJECTED ACCRUAL Approximately 20 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-G00-1857 | Registry Identifier | PDQ Physician Data Query | None |
| MCC-12275 | None | None | None |
| MCC-IRB-5473 | None | None | None |
| CDR0000068241 | REGISTRY | None | None |