Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098852
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
2004-12-08
Brief Title:
Rosiglitazone in Treating Patients With Locoregionally Extensive or Metastatic Thyroid Cancer
Sponsor:
University of California San Francisco
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study of Rosiglitazone in Patients With Incurable Differentiated Thyroid Cancer
Status:
UNKNOWN
Status Verified Date:
2009-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Drugs such as rosiglitazone may make tumor cells more sensitive to radioactive iodine
PURPOSE This phase II trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer
PURPOSE This phase II trial is studying how well rosiglitazone works in treating patients with locoregionally extensive or metastatic thyroid cancer
Detailed Description:
OBJECTIVES
Primary
Determine complete response in patients with locoregionally extensive or metastatic differentiated thyroid cancer treated with rosiglitazone
Secondary
Compare the long-term response of patients treated with this drug with historical controls
Determine the toxicity profile of this drug in these patients
Determine the presencepersistence of tumor in patients treated with this drug
Determine the quality of life of patients treated with this drug
Determine overall survival of patients treated with this drug
OUTLINE This is a pilot study
Patients receive oral rosiglitazone once daily on weeks 1-8 Patients also receive oral liothyronine sodium twice daily on weeks 1-6 in preparation for radioactive iodine scan Treatment continues in the absence of disease progression or unacceptable toxicity At week 8 all patients undergo whole body radioactive iodine scan followed by a treatment dose of radioiodine to assess radioiodine uptake by tumor
Quality of life is assessed at baseline and at the end of study treatment
Patients are followed at 2 weeks 1 4 and 10 months and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 20-25 patients will be accrued for this study
Primary
Determine complete response in patients with locoregionally extensive or metastatic differentiated thyroid cancer treated with rosiglitazone
Secondary
Compare the long-term response of patients treated with this drug with historical controls
Determine the toxicity profile of this drug in these patients
Determine the presencepersistence of tumor in patients treated with this drug
Determine the quality of life of patients treated with this drug
Determine overall survival of patients treated with this drug
OUTLINE This is a pilot study
Patients receive oral rosiglitazone once daily on weeks 1-8 Patients also receive oral liothyronine sodium twice daily on weeks 1-6 in preparation for radioactive iodine scan Treatment continues in the absence of disease progression or unacceptable toxicity At week 8 all patients undergo whole body radioactive iodine scan followed by a treatment dose of radioiodine to assess radioiodine uptake by tumor
Quality of life is assessed at baseline and at the end of study treatment
Patients are followed at 2 weeks 1 4 and 10 months and then every 6 months for 1 year
PROJECTED ACCRUAL A total of 20-25 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GSK-UCSF-H28355-22994-01 | None | None | None |
| UCSF-03201 | None | None | None |
| UCSF-H28355-22994-01 | None | None | None |