Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026533
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2001-11-09
Brief Title:
Thalidomide in Treating Patients With Thyroid Cancer
Sponsor:
Kenneth Ain
Organization:
University of Kentucky
Study Overview
Official Title:
Phase II Trial of Thalidomide for Therapy of Radioiodine-Unresponsive Papillary and Follicular Thyroid Carcinomas and Medullary Thyroid Carcinomas
Status:
COMPLETED
Status Verified Date:
2017-06
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 Thalidomide may stop the growth of thyroid cancer by stopping blood flow to the tumor
PURPOSE Phase II trial to study the effectiveness thalidomide in treating patients who have thyroid cancer
PURPOSE Phase II trial to study the effectiveness thalidomide in treating patients who have thyroid cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of thalidomide in terms of tumor response and duration of response in patients with metastatic follicular papillary or medullary thyroid carcinoma that is unresponsive to systemic radioiodine
Compare the differences in antitumor activity of this drug in patients with medullary carcinomas vs those with papillary or follicular carcinomas
Determine the toxic effects and duration of toxic effects of this drug in these patients
OUTLINE Patients receive oral thalidomide once daily for 2 weeks and then twice daily Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A maximum of 50 patients will be accrued for this study
Determine the antitumor activity of thalidomide in terms of tumor response and duration of response in patients with metastatic follicular papillary or medullary thyroid carcinoma that is unresponsive to systemic radioiodine
Compare the differences in antitumor activity of this drug in patients with medullary carcinomas vs those with papillary or follicular carcinomas
Determine the toxic effects and duration of toxic effects of this drug in these patients
OUTLINE Patients receive oral thalidomide once daily for 2 weeks and then twice daily Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A maximum of 50 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 |
|---|---|---|---|
| UKMC-IRB-010069 | None | None | None |