Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004062
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
1999-12-10
Brief Title:
Azacitidine to Restore Thyroid Function in Patients With Persistent or Metastatic Thyroid Cancer
Sponsor:
Lucille P Markey Cancer Center at University of Kentucky
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Restoration of Radioiodine Uptake in Thyroid Carcinoma A Clinical Trial
Status:
COMPLETED
Status Verified Date:
2004-05
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 Azacitidine may help thyroid cancer cells regain the ability to take up iodine This would allow the cancer to be detected and treated by radioactive iodine
PURPOSE Phase I trial to study the effectiveness of azacitidine to restore thyroid function in treating patients who have persistent or metastatic thyroid cancer
PURPOSE Phase I trial to study the effectiveness of azacitidine to restore thyroid function in treating patients who have persistent or metastatic thyroid cancer
Detailed Description:
OBJECTIVES I Determine the ability of azacitidine to restore iodine uptake by dedifferentiated thyroid cancer enabling detection and treatment with iodine I 131 in patients with metastatic follicular or papillary thyroid cancer II Evaluate different doses and schedules of azacitidine administration to determine an optimally effective combination for restoration of iodine I 131 uptake with acceptable toxicity in this patient population III Determine the efficacy of azacitidine plus iodine I 131 in this patient population
OUTLINE This is a dose escalation study of azacitidine Patients undergo a control phase consisting of oral liothyronine sodium twice daily on weeks 1-4 and a low iodine diet on weeks 4-7 At week 6 patients receive a scan dose of iodine I 131 followed by whole body scanning over 5 days Beginning at week 7 patients undergo a treatment phase consisting of oral liothyronine sodium twice daily for 3 weeks azacitidine subcutaneously daily for 10 or 20 days weeks 7-11 and a low iodine diet on weeks 8-11 During week 11 patients undergo additional whole body scanning over 5 days followed by a therapeutic dose of iodine I 131 Patients achieving successful therapy receive 5 additional doses of azacitidine Cohorts of 4 patients receive escalating doses of azacitidine until demonstrable radioiodine uptake is seen or the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity Patients are followed weekly for 8 weeks
PROJECTED ACCRUAL A total of 38 patients will be accrued for this study
OUTLINE This is a dose escalation study of azacitidine Patients undergo a control phase consisting of oral liothyronine sodium twice daily on weeks 1-4 and a low iodine diet on weeks 4-7 At week 6 patients receive a scan dose of iodine I 131 followed by whole body scanning over 5 days Beginning at week 7 patients undergo a treatment phase consisting of oral liothyronine sodium twice daily for 3 weeks azacitidine subcutaneously daily for 10 or 20 days weeks 7-11 and a low iodine diet on weeks 8-11 During week 11 patients undergo additional whole body scanning over 5 days followed by a therapeutic dose of iodine I 131 Patients achieving successful therapy receive 5 additional doses of azacitidine Cohorts of 4 patients receive escalating doses of azacitidine until demonstrable radioiodine uptake is seen or the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity Patients are followed weekly for 8 weeks
PROJECTED ACCRUAL A total of 38 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-T99-0045 | None | None | None |
| UKMC-9700053 | None | None | None |