Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003601
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
1999-11-01
Brief Title:
Tretinoin With or Without Fenretinide in Treating Patients With Dysplastic Nevus Syndrome
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Double-Blind Study of Topical Tretinoin With or Without Oral 4-HPR Fenretinide in Patients With the Dysplastic Nevus Syndrome
Status:
COMPLETED
Status Verified Date:
2023-06
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 tretinoin andor fenretinide may be an effective way to prevent the recurrence or further development of dysplastic nevus syndrome
PURPOSE Randomized phase II trial to compare the effectiveness of tretinoin with or without fenretinide in treating patients with dysplastic nevus syndrome
PURPOSE Randomized phase II trial to compare the effectiveness of tretinoin with or without fenretinide in treating patients with dysplastic nevus syndrome
Detailed Description:
OBJECTIVES I Compare the efficacy clinical and histologic evidence of regression of topical tretinoin with or without systemic fenretinide in patients with dysplastic nevi with personal or family history of cutaneous melanoma
OUTLINE This is a randomized double-blind study Patients are stratified according to personal history of cutaneous melanoma vs family history of cutaneous melanoma in at least 2 blood relatives Patients are randomized to one of two treatment arms Arm I Patients receive topical tretinoin twice daily and oral fenretinide once a day for 6 months Tretinoin is applied to one half of the back with the untreated side of the back serving as a matched control Arm II Patients receive topical tretinoin as in arm I twice daily and oral placebo once a day for 6 months Treatment continues in both arms in the absence of disease progression or unacceptable toxicity Patients are followed at 6 months
PROJECTED ACCRUAL There will be 38 patients accrued for this study
OUTLINE This is a randomized double-blind study Patients are stratified according to personal history of cutaneous melanoma vs family history of cutaneous melanoma in at least 2 blood relatives Patients are randomized to one of two treatment arms Arm I Patients receive topical tretinoin twice daily and oral fenretinide once a day for 6 months Tretinoin is applied to one half of the back with the untreated side of the back serving as a matched control Arm II Patients receive topical tretinoin as in arm I twice daily and oral placebo once a day for 6 months Treatment continues in both arms in the absence of disease progression or unacceptable toxicity Patients are followed at 6 months
PROJECTED ACCRUAL There will be 38 patients 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 |
|---|---|---|---|
| E-2695 | None | None | None |
| UPCC-2600 | None | None | None |
| NCI-P98-0134 | None | None | None |