Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082719
Status:
COMPLETED
Last Update Posted:
2015-05-14
First Post:
2004-05-14
Brief Title:
Short-Term Low-Dose Interferon Alfa in Treating Patients With Cancer of the Urothelium
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Modulation of Death Effector Expression By Short-Term Exposure to Low-Dose Interferon
Status:
COMPLETED
Status Verified Date:
2015-05
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 Interferon alfa may interfere with the growth of tumor cells and slow the growth of urothelial cancer
PURPOSE This randomized phase I trial is studying how well low-dose interferon alfa works in treating patients with cancer of the urothelium
PURPOSE This randomized phase I trial is studying how well low-dose interferon alfa works in treating patients with cancer of the urothelium
Detailed Description:
OBJECTIVES
Determine the modulation of apoptosis-related pathways in patients with cancer of the urothelium treated with short-term low-dose interferon alfa
OUTLINE This is a randomized study Patients are randomized to 1 of 4 treatment arms
In all arms treatment begins at the time of the pre-operative visit and continues until the time of cystoscopy
Arm I Patients receive low-dose interferon alfa subcutaneously SC twice daily
Arm II Patients receive interferon alfa as in arm I at a higher dose
Arm III Patients receive interferon alfa SC once daily
Arm IV Patients receive interferon alfa as in arm III at a higher dose In all arms treatment continues in the absence of unacceptable toxicity
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
Determine the modulation of apoptosis-related pathways in patients with cancer of the urothelium treated with short-term low-dose interferon alfa
OUTLINE This is a randomized study Patients are randomized to 1 of 4 treatment arms
In all arms treatment begins at the time of the pre-operative visit and continues until the time of cystoscopy
Arm I Patients receive low-dose interferon alfa subcutaneously SC twice daily
Arm II Patients receive interferon alfa as in arm I at a higher dose
Arm III Patients receive interferon alfa SC once daily
Arm IV Patients receive interferon alfa as in arm III at a higher dose In all arms treatment continues in the absence of unacceptable toxicity
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
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-2012-02015 | REGISTRY | NCI CTRP | httpsreporternihgovquickSearchP30CA016672 |
| P50CA091846 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-ID-030172 | OTHER | None | None |
| CDR0000355831 | REGISTRY | None | None |