Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072189
Status:
TERMINATED
Last Update Posted:
2015-03-02
First Post:
2003-11-04
Brief Title:
A Phase II Study of UCN-01 in Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of UCN-01 in Metastatic Melanoma
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early termination for discouraging results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth This phase II trial is studying how well UCN-01 works in treating patients with metastatic melanoma
Detailed Description:
PRIMARY OBJECTIVES
I To assess the anti-tumor activity of UCN-01 7-hydroxystaurosporine in metastatic melanoma as determined by the response rate
II To assess the clinical and laboratory toxicities of UCN-01 III To study the effects of UCN-01 administration on potential markers of specific G1-phase cell cycle regulators
OUTLINE This is a multicenter study
Patients receive UCN-01 IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 17-33 patients will be accrued for this study within 18 months
I To assess the anti-tumor activity of UCN-01 7-hydroxystaurosporine in metastatic melanoma as determined by the response rate
II To assess the clinical and laboratory toxicities of UCN-01 III To study the effects of UCN-01 administration on potential markers of specific G1-phase cell cycle regulators
OUTLINE This is a multicenter study
Patients receive UCN-01 IV over 3 hours on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 17-33 patients will be accrued for this study within 18 months
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-2012-02829 | REGISTRY | None | None |
| PHII-33 | OTHER | None | None |
| 5536 | OTHER | None | None |
| N01CM17101 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17101 |