Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00021294
Status:
COMPLETED
Last Update Posted:
2018-09-11
First Post:
2001-07-11
Brief Title:
Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Phase IIB Randomized Double-Blinded Placebo Controlled Study to Evaluate the Safety and Efficacy of Topical Difluoromethylornithine DFMO With and Without a Topical Corticosteroid Cream Triamcinolone 01 in the Therapy of Actinic Keratoses AK on the Forearms
Status:
COMPLETED
Status Verified Date:
2018-09
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 Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer Eflornithine with or without triamcinolone may be effective in preventing nonmelanoma skin cancer
PURPOSE Randomized phase II trial to compare the effectiveness of eflornithine with or without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic keratosis
PURPOSE Randomized phase II trial to compare the effectiveness of eflornithine with or without triamcinolone in preventing nonmelanoma skin cancer in patients who have actinic keratosis
Detailed Description:
OBJECTIVES I Compare the safety and efficacy of eflornithine DFMO vs placebo as chemoprevention of non-melanoma skin cancer in patients with moderate to heavy actinic keratosis AK II Determine whether this drug reverses AK in these patients III Determine whether triamcinolone reduces DFMO-induced skin irritation in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to 1 of 4 treatment arms Arm I Patients receive eflornithine DFMO topically and triamcinolone topically to forearms once daily Arm II Patients receive DFMO and placebo topically as in arm I Arm III Patients receive placebo and triamcinolone topically as in arm I Arm IV Patients receive 2 placebos topically as in arm I Treatment continues for 6 months in the absence of unacceptable toxicity Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study within 1 year
OUTLINE This is a randomized double-blind placebo-controlled study Patients are randomized to 1 of 4 treatment arms Arm I Patients receive eflornithine DFMO topically and triamcinolone topically to forearms once daily Arm II Patients receive DFMO and placebo topically as in arm I Arm III Patients receive placebo and triamcinolone topically as in arm I Arm IV Patients receive 2 placebos topically as in arm I Treatment continues for 6 months in the absence of unacceptable toxicity Patients are followed at 2 weeks
PROJECTED ACCRUAL A total of 150 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-H01-0075 | US NIH GrantContract | None | httpsreporternihgovquickSearchP01CA027502 |
| P01CA027502 | NIH | None | None |
| UARIZ-HSC-0072 | None | None | None |