Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098813
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2004-12-08
Brief Title:
Romidepsin in Treating Patients With Recurrent andor Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Single Agent Depsipeptide FK228 in Radioiodine RAI-Refractory Metastatic Non-medullary Papillary Follicular and Hurthle Cell Variants Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-10
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 romidepsin works in treating patients with recurrent andor metastatic thyroid cancer that has not responded to radioactive iodine Romidepsin may stop the growth of tumor cells by blocking the some of the enzymes needed for cell growth It may also help radioactive iodine and chemotherapy work better by making tumor cells more sensitive to the drug
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor activity of romidepsin depsipeptide in terms of the proportion of patients achieving a complete or partial response or disease stabilization in patients with progressive recurrent andor metastatic non-medullary thyroid carcinoma that is refractory to radioactive iodine RAI
II Determine the safety and tolerability of this drug in these patients
SECONDARY OBJECTIVES
I Document changes in RAI uptake by comparing pre- and post-treatment RAI scans in patients treated with this drug
II Evaluate changes in the expression of the NaI- symporter NIS in tumors as measured by immunohistochemistry on pre- and post-treatment biopsy specimens and real time reverse transcriptase polymerase chain reaction RT-PCR for NIS mRNA on pre- and post-treatment changes biopsy specimens
III Determine post-treatment changes in serum thyroglobulin in patients treated with this drug
IV Correlate changes in post-treatment positron-emission tomography scans with whole-body RAI scans in patients treated with this drug
OUTLINE
Patients receive romidepsin IV over 4 hours on days 1 8 and 15 Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression
I Determine the antitumor activity of romidepsin depsipeptide in terms of the proportion of patients achieving a complete or partial response or disease stabilization in patients with progressive recurrent andor metastatic non-medullary thyroid carcinoma that is refractory to radioactive iodine RAI
II Determine the safety and tolerability of this drug in these patients
SECONDARY OBJECTIVES
I Document changes in RAI uptake by comparing pre- and post-treatment RAI scans in patients treated with this drug
II Evaluate changes in the expression of the NaI- symporter NIS in tumors as measured by immunohistochemistry on pre- and post-treatment biopsy specimens and real time reverse transcriptase polymerase chain reaction RT-PCR for NIS mRNA on pre- and post-treatment changes biopsy specimens
III Determine post-treatment changes in serum thyroglobulin in patients treated with this drug
IV Correlate changes in post-treatment positron-emission tomography scans with whole-body RAI scans in patients treated with this drug
OUTLINE
Patients receive romidepsin IV over 4 hours on days 1 8 and 15 Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression
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 |
|---|---|---|---|
| CDR0000396783 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62206 |
| 04-059 | None | None | None |
| N01CM62206 | NIH | None | None |