Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005968
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2000-07-05
Brief Title:
Irofulven in Treating Patients With Stage IV Melanoma
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
A Multicenter Phase II Trial of MGI-114 in Patients With Stage IV Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2002-12
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients who have stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of irofulven in treating patients who have stage IV melanoma
Detailed Description:
OBJECTIVES I Determine the response rate and duration of response in patients with stage IV malignant melanoma treated with 6-hydroxymethylacylfulvene II Determine the toxicity of this regimen in these patients
OUTLINE This is a multicenter study Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-5 Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after completion of course 2 receive additional courses Patients are followed every 3 months for 5 years and then annually thereafter until death
PROJECTED ACCRUAL Approximately 16-35 patients will be accrued for this study within 1 year
OUTLINE This is a multicenter study Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes on days 1-5 Treatment repeats every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease after completion of course 2 receive additional courses Patients are followed every 3 months for 5 years and then annually thereafter until death
PROJECTED ACCRUAL Approximately 16-35 patients will be accrued for this study within 1 year
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-T99-0070 | None | None | None |
| UCHSC-99468 | None | None | None |