Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00118248
Status:
COMPLETED
Last Update Posted:
2017-02-15
First Post:
2005-07-08
Brief Title:
Tanespimycin in Treating Patients With Inoperable Locoregionally Advanced or Metastatic Thyroid Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of 17-Allylaminogeldanamycin 17AAG in Advanced Medullary and Differentiated Thyroid Carcinoma
Status:
COMPLETED
Status Verified Date:
2016-12
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 tanespimycin works in treating patients with inoperable locoregionally advanced or metastatic thyroid cancer Drugs used in chemotherapy such as tanespimycin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
PRIMARY OBJECTIVES
I Determine the 1-year treatment failure rate in patients with inoperable locoregionally advanced or metastatic medullary or differentiated thyroid carcinoma treated with 17-N-allylamino-17-demethoxygeldanamycin 17-AAG tanespimycin
SECONDARY OBJECTIVES
I Determine the toxicity of this drug in these patients Determine the 1-year progression-free rate in patients treated with this drug
II Determine the response rate and duration of response in patients treated with this drug
III Determine the time to treatment failure and time to subsequent therapy in patients treated with this drug
IV Determine the time to disease progression and overall survival of patients treated with this drug
V Correlate the incidence rate of RAS RAF and RET mutations with clinical outcome in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to type of thyroid carcinoma medullary vs differentiated
Patients receive tanespimycin intravenously IV over 2-6 hours on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry
I Determine the 1-year treatment failure rate in patients with inoperable locoregionally advanced or metastatic medullary or differentiated thyroid carcinoma treated with 17-N-allylamino-17-demethoxygeldanamycin 17-AAG tanespimycin
SECONDARY OBJECTIVES
I Determine the toxicity of this drug in these patients Determine the 1-year progression-free rate in patients treated with this drug
II Determine the response rate and duration of response in patients treated with this drug
III Determine the time to treatment failure and time to subsequent therapy in patients treated with this drug
IV Determine the time to disease progression and overall survival of patients treated with this drug
V Correlate the incidence rate of RAS RAF and RET mutations with clinical outcome in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to type of thyroid carcinoma medullary vs differentiated
Patients receive tanespimycin intravenously IV over 2-6 hours on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry
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-2009-00063 | REGISTRY | None | None |
| JHOC-B06174 | None | None | None |
| NCI-6482 | None | None | None |
| JHOC-JS0652 | None | None | None |
| CDR0000433150 | None | None | None |
| MC0476 | OTHER | None | None |
| 6482 | OTHER | None | None |
| N01CM62205 | NIH | None | None |
| P30CA015083 | NIH | None | None |
| N01CM62207 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62207 |