Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079131
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2004-03-08
Brief Title:
Oblimersen in Treating Patients With Merkel Cell Carcinoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of G3139 Genasense in Patients With Merkel Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 oblimersen works in treating patients with Merkel cell cancer Biological therapies such as oblimersen may interfere with the growth of tumor cells and slow the growth of Merkel cell carcinoma skin cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the overall response rate in patients with Merkel cell carcinoma treated with oblimersen
SECONDARY OBJECTIVES
I Determine the time to progression in patients treated with this drug II Determine the response duration in patients treated with this drug III Determine the safety and tolerability of this drug in these patients IV Determine the pharmacodynamic effects of this drug on bcl-2 expression and apoptosis in tumor biopsy specimens from these patients
OUTLINE This is an open-label multicenter study
Patients receive oblimersen IV continuously on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
I Determine the overall response rate in patients with Merkel cell carcinoma treated with oblimersen
SECONDARY OBJECTIVES
I Determine the time to progression in patients treated with this drug II Determine the response duration in patients treated with this drug III Determine the safety and tolerability of this drug in these patients IV Determine the pharmacodynamic effects of this drug on bcl-2 expression and apoptosis in tumor biopsy specimens from these patients
OUTLINE This is an open-label multicenter study
Patients receive oblimersen IV continuously on days 1-14 Courses repeat every 21 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 |
| 03-105 | None | None | None |
| CDR0000354418 | None | None | None |
| NCI-5907 | None | None | None |
| MSKCC-03105 | None | None | None |
| N01CM62207 | NIH | None | None |