Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005884
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2000-06-02
Brief Title:
Eflornithine to Prevent Skin Cancer in Patients With Previously Treated Early Stage Skin Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Chemoprevention of Skin Cancers With DFMO A Controlled Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2015-09
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 The use of eflornithine may be an effective way to prevent the recurrence of or further development of skin cancer
PURPOSE Randomized phase III trial to determine the effectiveness of eflornithine in preventing skin cancer in patients who have previously received treatment for early stage skin cancer
PURPOSE Randomized phase III trial to determine the effectiveness of eflornithine in preventing skin cancer in patients who have previously received treatment for early stage skin cancer
Detailed Description:
OBJECTIVES I Compare the rate of new skin cancer in patients with previously treated stage 0 I or II basal or squamous cell skin cancer treated with eflornithine DFMO vs placebo II Determine whether inhibition of TPA-induced ornithine decarboxylase activity serves as an intermediary marker for response to DFMO in these patients III Determine whether inhibition of skin polyamine levels serves as an intermediary marker for response to DFMO in these patients IV Assess the long term toxic effects of this treatment in these patients
OUTLINE This a randomized double blind placebo controlled multicenter study Patients receive oral placebo daily for the first 4 weeks Patients who comply with taking 80-100 of placebo are randomized to one of two treatment arms Arm I Patients receive oral eflornithine DFMO daily Arm II Patients receive an oral placebo daily Treatment continues for 3-5 years in the absence of unacceptable toxicity Patients who develop skin cancer during study undergo surgical excision and continue treatment on the arm to which they were originally randomized Patients are followed every 6 months through year 5
PROJECTED ACCRUAL A total of 334 patients 167 per arm will be accrued for this study over 2 years
OUTLINE This a randomized double blind placebo controlled multicenter study Patients receive oral placebo daily for the first 4 weeks Patients who comply with taking 80-100 of placebo are randomized to one of two treatment arms Arm I Patients receive oral eflornithine DFMO daily Arm II Patients receive an oral placebo daily Treatment continues for 3-5 years in the absence of unacceptable toxicity Patients who develop skin cancer during study undergo surgical excision and continue treatment on the arm to which they were originally randomized Patients are followed every 6 months through year 5
PROJECTED ACCRUAL A total of 334 patients 167 per arm will be accrued for this study over 2 years
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-P00-0155 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA077158 |
| U01CA077158 | NIH | None | None |
| WCCC-CO-9737 | None | None | None |