Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003390
Status:
COMPLETED
Last Update Posted:
2013-06-21
First Post:
1999-11-01
Brief Title:
6-Hydroxymethylacylfulvene in Treating Patients With Metastatic Kidney Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of 6-Hydroxymethylacylfulvene MGI-114 in Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2000-05
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 6-hydroxymethylacylfulvene in treating patients with metastatic kidney cancer
PURPOSE Phase II trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients with metastatic kidney cancer
Detailed Description:
OBJECTIVES I Evaluate the efficacy of 6-hydroxymethylacylfulvene HMAF in patients with metastatic renal cell carcinoma II Investigate the safety of HMAF given to this patient population
OUTLINE Patients receive 6-hydroxymethylacylfulvene intravenously for 5 minutes every day for 5 consecutive days Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed after every 2 treatment courses
PROJECTED ACCRUAL Approximately 12-37 patients will be accrued for this study within 6-19 months
OUTLINE Patients receive 6-hydroxymethylacylfulvene intravenously for 5 minutes every day for 5 consecutive days Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity Patients are followed after every 2 treatment courses
PROJECTED ACCRUAL Approximately 12-37 patients will be accrued for this study within 6-19 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-T97-0119 | None | None | None |
| MSKCC-98009 | None | None | None |
| MSKCC-98007 | None | None | None |