Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087386
Status:
TERMINATED
Last Update Posted:
2013-04-10
First Post:
2004-07-08
Brief Title:
Tanespimycin in Treating Patients With Stage III-IV Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of 17-N-allylamino-17-demethoxy Geldanamycin 17-AAG NSC 330507 Diluted in EPL Diluent NSC 704057 in Metastatic Melanoma Patients
Status:
TERMINATED
Status Verified Date:
2013-04
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 stage III or stage IV melanoma Antitumor antibiotics such as tanespimycin may stop the growth of melanoma by stopping blood flow to the tumor
Detailed Description:
PRIMARY OBJECTIVES
I Determine if treatment with 17-AAG results in measurable anti-tumor effects and calculate the proportion of clinical responses
II Test the hypothesis that treatment with 17-AAG can disrupt the MAPK pathway by depleting intra-tumor stores of RAF kinases andor downstream proteins such as phospho-ERK CDK4 and cyclin D1
III Determine if either of these effects correlates with the presence of mutated BRAF within the melanoma tumor
OUTLINE This is a multicenter study Patients are stratified according to presence of BRAF mutation in tumor yes vs no
Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity
I Determine if treatment with 17-AAG results in measurable anti-tumor effects and calculate the proportion of clinical responses
II Test the hypothesis that treatment with 17-AAG can disrupt the MAPK pathway by depleting intra-tumor stores of RAF kinases andor downstream proteins such as phospho-ERK CDK4 and cyclin D1
III Determine if either of these effects correlates with the presence of mutated BRAF within the melanoma tumor
OUTLINE This is a multicenter study Patients are stratified according to presence of BRAF mutation in tumor yes vs no
Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM62206 | NIH | None | httpsreporternihgovquickSearchN01CM62206 |
| 04-056 | None | None | None |
| NCI-6480 | None | None | None |
| CDR0000374980 | None | None | None |
| MSKCC-04056 | None | None | None |