Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024011
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2001-09-13
Brief Title:
PS-341 in Treating Patients With Metastatic Malignant Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of PS-341 in the Treatment of Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic malignant melanoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the progression-free survival at 18 weeks and overall survival of patients with metastatic malignant melanoma treated with PS-341
II Determine the objective response rate of patients treated with this drug III Correlate p27 levels in tumor tissue with objective response rate in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive PS-341 IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3-6 months for up to 2 years after registration
PROJECTED ACCRUAL A total of 22-50 patients will be accrued for this study within 12 months
I Determine the progression-free survival at 18 weeks and overall survival of patients with metastatic malignant melanoma treated with PS-341
II Determine the objective response rate of patients treated with this drug III Correlate p27 levels in tumor tissue with objective response rate in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive PS-341 IV over 3-5 seconds on days 1 4 8 and 11 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3-6 months for up to 2 years after registration
PROJECTED ACCRUAL A total of 22-50 patients will be accrued for this study within 12 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 |
|---|---|---|---|
| MC007A | None | None | None |
| N01CM17104 | NIH | None | None |
| CDR0000068883 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17104 |