Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-04 @ 4:54 AM
Study NCT ID:
NCT01833767
Status:
WITHDRAWN
Last Update Posted:
2017-08-24
First Post:
2013-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Cyclophosphamide and Outpatient IV Interleukin-2 in Metastatic Melanoma
Sponsor:
Western Regional Medical Center
Organization:
Study Overview
Official Title:
Phase 2 Trial of T-cell Based Low-dose Cyclophosphamide and Outpatient Intravenous Interleukin-2 in Metastatic Melanoma
Status:
WITHDRAWN
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine response rates by administering low dose cyclophosphamide on day 1, followed by 5 days of outpatient IL2.
Detailed Description:
To determine the response rate, median duration of response and median survival of patients treated with this low-dose cyclophosphamide + moderate dose bolus Interleukin-2 schedule.
Study Oversight
Has Oversight DMC:
False
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?: