Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381641
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2006-09-26
Brief Title:
Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Sunitinib SU11248 in Iodine-131 Refractory Unresectable Differentiated Thyroid Cancers and Medullary Thyroid Cancers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
This phase II trial studies how well sunitinib malate works in treating patients with thyroid cancer that did not respond to iodine I 131 radioactive iodine and cannot be removed by surgery Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate of single agent sunitinib sunitinib malate in patients with iodine refractory unresectable well-differentiated thyroid cancer WDTC who have evidence of disease progression within 6 months of study enrollment
II Determine the response rate of single agent sunitinib in patients with medullary thyroid cancer MTC who have evidence of disease progression within 6 months of study enrollment
III Determine the toxicity duration of response progression free survival and overall survival in patients with WDTC or MTC treated with single agent sunitinib
IV Determine whether the presence of ret proto-oncogene RET gene rearrangements in patients with WDTC or RET mutations in patients with MTC predict response to sunitinib
V Determine whether therapy with sunitinib affects phosphorylation of downstream RET effector mitogen-activated protein kinase 1 ERK in WDTC and MTC tissue
VI Determine whether specific germ-line polymorphisms in the RET gene are associated with favorable outcome in patients with WDTC treated with sunitinib
OUTLINE Patients are assigned to 1 of 2 cohorts according to type of thyroid cancer medullary vs well-differentiated
Patients receive sunitinib malate orally PO once daily QD on days 1-28 Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically for up to 2 years
I Determine the response rate of single agent sunitinib sunitinib malate in patients with iodine refractory unresectable well-differentiated thyroid cancer WDTC who have evidence of disease progression within 6 months of study enrollment
II Determine the response rate of single agent sunitinib in patients with medullary thyroid cancer MTC who have evidence of disease progression within 6 months of study enrollment
III Determine the toxicity duration of response progression free survival and overall survival in patients with WDTC or MTC treated with single agent sunitinib
IV Determine whether the presence of ret proto-oncogene RET gene rearrangements in patients with WDTC or RET mutations in patients with MTC predict response to sunitinib
V Determine whether therapy with sunitinib affects phosphorylation of downstream RET effector mitogen-activated protein kinase 1 ERK in WDTC and MTC tissue
VI Determine whether specific germ-line polymorphisms in the RET gene are associated with favorable outcome in patients with WDTC treated with sunitinib
OUTLINE Patients are assigned to 1 of 2 cohorts according to type of thyroid cancer medullary vs well-differentiated
Patients receive sunitinib malate orally PO once daily QD on days 1-28 Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically for up to 2 years
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 |
|---|---|---|---|
| P30CA014599 | NIH | CTEP | httpsreporternihgovquickSearchP30CA014599 |
| NCI-2009-00213 | REGISTRY | None | None |
| UCCRC-14696A | None | None | None |
| CDR0000502260 | None | None | None |
| NCI-7735 | None | None | None |
| 14696A | None | None | None |
| 7735 | OTHER | None | None |
| 7735 | OTHER | None | None |
| N01CM62201 | NIH | None | None |
| N01CM62202 | NIH | None | None |