Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002947
Status:
TERMINATED
Last Update Posted:
2014-07-02
First Post:
1999-11-01
Brief Title:
Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
A Phase I Study of 111In-DTPA-D-Phe-Octreotide in Patients With Refractory Malignancies Expressing Somatostatin Receptors
Status:
TERMINATED
Status Verified Date:
2014-07
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 Radiation therapy uses high-energy x-rays and other sources to damage tumor cells Giving radiation therapy in different ways may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating patients who have refractory cancer
PURPOSE Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating patients who have refractory cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD toxic effects and the preliminary antitumor activity of indium In 111 pentetreotide
OUTLINE This is a dose escalation study Patients receive indium In III pentetreotide OctreoScan IV on day 1 Imaging is conducted on days 3 and 6 Treatment continues weekly for a total of 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of at least 3 patients receive escalating doses of OctreoScan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities Patients are followed every 3 months for the first year then every 6 months thereafter
PROJECTED ACCRUAL Up to 35 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive indium In III pentetreotide OctreoScan IV on day 1 Imaging is conducted on days 3 and 6 Treatment continues weekly for a total of 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of at least 3 patients receive escalating doses of OctreoScan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose limiting toxicities Patients are followed every 3 months for the first year then every 6 months thereafter
PROJECTED ACCRUAL Up to 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-G97-1154 | None | None | None |
| YALE-HIC-9041 | None | None | None |