Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT00085293
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2004-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine
Status:
COMPLETED
Status Verified Date:
2018-10
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 is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells. Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine. Decitabine may help thyroid cancer cells regain the ability to respond to treatment with radioactive iodine.
Detailed Description:
PRIMARY OBJECTIVE:
I. Determine whether decitabine can restore iodine I 131 (131I) uptake in patients with metastatic papillary thyroid or follicular thyroid cancer lesions that are undetectable by low-dose iodine 131I scanning.
SECONDARY OBJECTIVES:
I. Determine the efficacy of 131I therapy, administered after restoration of 131I uptake by decitabine, in these patients.
II. Determine the effect of decitabine on clinical and molecular markers of thyroid cancer cell differentiation in these patients.
III. Determine the safety and tolerability of decitabine in patients undergoing thyroid hormone withdrawal-induced hypothyroidism and 131I therapy.
OUTLINE: This is an open-label, multicenter study.
Patients receive decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). On week 3, patients undergo iodine I 131 (131I) scanning using thyrotropin alfa injections. Patients whose scan does not demonstrate iodine uptake continue suppressive thyroid hormone therapy but receive no further study therapy. These patients undergo study follow up.
Patients whose scan demonstrates iodine uptake undergo thyroid hormone withdrawal on weeks 4-8 and receive a second course of decitabine (as in course 1) on weeks 7 and 8. Patients then receive 131I therapy on week 9.
Patients are followed at 3 and 6 months.
I. Determine whether decitabine can restore iodine I 131 (131I) uptake in patients with metastatic papillary thyroid or follicular thyroid cancer lesions that are undetectable by low-dose iodine 131I scanning.
SECONDARY OBJECTIVES:
I. Determine the efficacy of 131I therapy, administered after restoration of 131I uptake by decitabine, in these patients.
II. Determine the effect of decitabine on clinical and molecular markers of thyroid cancer cell differentiation in these patients.
III. Determine the safety and tolerability of decitabine in patients undergoing thyroid hormone withdrawal-induced hypothyroidism and 131I therapy.
OUTLINE: This is an open-label, multicenter study.
Patients receive decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). On week 3, patients undergo iodine I 131 (131I) scanning using thyrotropin alfa injections. Patients whose scan does not demonstrate iodine uptake continue suppressive thyroid hormone therapy but receive no further study therapy. These patients undergo study follow up.
Patients whose scan demonstrates iodine uptake undergo thyroid hormone withdrawal on weeks 4-8 and receive a second course of decitabine (as in course 1) on weeks 7 and 8. Patients then receive 131I therapy on week 9.
Patients are followed at 3 and 6 months.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00033 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CDR0000368467 | None | None | View | |
| 5954 | None | None | View | |
| 2003-0308 | OTHER | M D Anderson Cancer Center | View | |
| 5954 | OTHER | CTEP | View | |
| P30CA016672 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM62207 | NIH | None | https://reporter.nih.gov/quic… | View |