Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003611
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
1999-11-01
Brief Title:
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Chemoprevention Trial of Acitretin Versus Placebo in Solid Organ Transplant Recipients With Multiple Prior Treated Skin Cancers
Status:
COMPLETED
Status Verified Date:
2016-07
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 acitretin may be an effective way to prevent the recurrence or further development of skin cancer
PURPOSE Randomized clinical trial to study the effectiveness of acitretin in preventing skin cancers in patients with at least two previously treated skin cancers who have undergone organ transplantation
PURPOSE Randomized clinical trial to study the effectiveness of acitretin in preventing skin cancers in patients with at least two previously treated skin cancers who have undergone organ transplantation
Detailed Description:
OBJECTIVES
Determine the chemopreventive efficacy of acitretin in immunosuppressed solid organ transplant recipients with a history of multiple previous basal cell carcinoma BCC or squamous cell carcinoma SCC skin cancer resections
Evaluate human papillomavirus HPV as a possible etiologic cofactor in the development of cutaneous epidermal dysplasiacarcinoma from skin tissues of these patients
Determine the effect of acitretin on potential surrogate endpoint biomarkers and HPV DNA in normal sun protected sun-exposed and dysplastic and carcinoma SCCBCC skin specimens
OUTLINE This is a randomized study Patients are stratified according to age at least 18 to under 50 vs 50 to 59 vs 60 to 69 vs 70 and over number of prior skin cancers in past 5 years 2 vs 3 vs at least 4 time since most recent skin cancer occurrence less than 12 months vs at least 12 months sunburn susceptibility none vs moderate vs high visible skin damage mild vs moderate vs severe
Patients receive either oral acitretin or placebo daily for 2 years Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies
Patients are followed every 6 months
Determine the chemopreventive efficacy of acitretin in immunosuppressed solid organ transplant recipients with a history of multiple previous basal cell carcinoma BCC or squamous cell carcinoma SCC skin cancer resections
Evaluate human papillomavirus HPV as a possible etiologic cofactor in the development of cutaneous epidermal dysplasiacarcinoma from skin tissues of these patients
Determine the effect of acitretin on potential surrogate endpoint biomarkers and HPV DNA in normal sun protected sun-exposed and dysplastic and carcinoma SCCBCC skin specimens
OUTLINE This is a randomized study Patients are stratified according to age at least 18 to under 50 vs 50 to 59 vs 60 to 69 vs 70 and over number of prior skin cancers in past 5 years 2 vs 3 vs at least 4 time since most recent skin cancer occurrence less than 12 months vs at least 12 months sunburn susceptibility none vs moderate vs high visible skin damage mild vs moderate vs severe
Patients receive either oral acitretin or placebo daily for 2 years Skin biopsies are obtained at 1 year from normal areas and from any areas with skin cancer for genetic studies
Patients are followed every 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 |
|---|---|---|---|
| NCI-P98-0137 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066688 | REGISTRY | None | None |