Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089180
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2004-08-04
Brief Title:
T4N5 Liposomal Lotion in Preventing The Recurrence of Nonmelanoma Skin Cancer in Patients Who Have Undergone a Kidney Transplant
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase IIb Randomized Double-Blind Placebo-Controlled Clinical Trial of Topical Bacteriophage T4 Endonuclease V in Renal Allograft Recipients With a History of Non-melanoma Skin Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This randomized phase II trial is studying how well T4N5 liposomal lotion works in preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant Chemoprevention therapy is the use of certain drugs to try to prevent the development of or recurrence of cancer T4N5 liposomal lotion may be effective preventing the recurrence of nonmelanoma skin cancer in patients who have undergone a kidney transplant
Detailed Description:
PRIMARY OBJECTIVES
I Compare the incidence of nonmelanoma skin cancer NMSC average per patient on the sun-exposed skin of renal transplant recipients with a history of NMSC treated with T4N5 liposomal lotion vs placebo
SECONDARY OBJECTIVES
I Compare the proportion of these patients who develop NMSC on sun-exposed skin during treatment and after cessation of treatment with these regimens
II Compare the incidence of NMSC on the sun-exposed skin of these patients after cessation of treatment with these regimens
III Compare the incidence of recurrent and de novo actinic keratoses AKs in patients treated with these regimens
IV Determine whether either of these regimens induces regression of AKs left untreated on the sun-exposed skin of these patients
V Compare the proportion of these patients who develop melanoma in both treated and untreated sites during and after cessation of treatment with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to study center Patients are randomized to 1 of 2 arms
Six months before randomization lesions suspicious for nonmelanoma skin cancer NMSC are surgically removed and histologically analyzed All but 10 randomly selected non-suspicious lesions are removed Of these 10 lesions 5 are shave biopsied immediately pre-treatment for histologic and surrogate endpoint biomarker SEB analysis and to determine a baseline actinic keratosis wart ratio Patients also undergo a pre-treatment biopsy of normal appearing sun-exposed and non-sun-exposed skin buttocks
Arm I Patients apply T4N5 liposomal lotion topically to non-occluded sun-exposed areas of the head neck face and upper extremities once daily for 12 months
Arm II Patients apply placebo topically to non-occluded sun-exposed areas of the head neck face and upper extremities once daily for 12 months
Treatment in both arms continues in the absence of the development of metastatic cutaneous squamous cell cancer or melanoma Patients are followed every 3 months
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study within 6 months
I Compare the incidence of nonmelanoma skin cancer NMSC average per patient on the sun-exposed skin of renal transplant recipients with a history of NMSC treated with T4N5 liposomal lotion vs placebo
SECONDARY OBJECTIVES
I Compare the proportion of these patients who develop NMSC on sun-exposed skin during treatment and after cessation of treatment with these regimens
II Compare the incidence of NMSC on the sun-exposed skin of these patients after cessation of treatment with these regimens
III Compare the incidence of recurrent and de novo actinic keratoses AKs in patients treated with these regimens
IV Determine whether either of these regimens induces regression of AKs left untreated on the sun-exposed skin of these patients
V Compare the proportion of these patients who develop melanoma in both treated and untreated sites during and after cessation of treatment with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to study center Patients are randomized to 1 of 2 arms
Six months before randomization lesions suspicious for nonmelanoma skin cancer NMSC are surgically removed and histologically analyzed All but 10 randomly selected non-suspicious lesions are removed Of these 10 lesions 5 are shave biopsied immediately pre-treatment for histologic and surrogate endpoint biomarker SEB analysis and to determine a baseline actinic keratosis wart ratio Patients also undergo a pre-treatment biopsy of normal appearing sun-exposed and non-sun-exposed skin buttocks
Arm I Patients apply T4N5 liposomal lotion topically to non-occluded sun-exposed areas of the head neck face and upper extremities once daily for 12 months
Arm II Patients apply placebo topically to non-occluded sun-exposed areas of the head neck face and upper extremities once daily for 12 months
Treatment in both arms continues in the absence of the development of metastatic cutaneous squamous cell cancer or melanoma Patients are followed every 3 months
PROJECTED ACCRUAL A total of 100 patients 50 per treatment arm will be accrued for this study within 6 months
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 |
|---|---|---|---|
| UAB-0323 | None | None | None |
| CDR0000378098 | None | None | None |
| N01CN15136 | OTHER_GRANT | US NIH GrantContract Award Number | None |