Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025012
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-10-11
Brief Title:
Isotretinoin in Preventing Skin Cancer
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Use Of Isotretinion For Prevention Of Skin Cancer In Patients With Xeroderma Pigmentosum Or Nevoid Basal Cell Carcinoma Syndrome
Status:
COMPLETED
Status Verified Date:
2007-11
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 Isotretinoin may be effective in preventing the development or recurrence of skin cancer
PURPOSE Clinical trial to study the effectiveness of isotretinoin in preventing or slowing the growth of skin cancer in patients who have xeroderma pigmentosum or basal cell carcinoma
PURPOSE Clinical trial to study the effectiveness of isotretinoin in preventing or slowing the growth of skin cancer in patients who have xeroderma pigmentosum or basal cell carcinoma
Detailed Description:
OBJECTIVES I Determine the lowest effective dose of oral isotretinoin for long-term therapy that is capable of reducing the rate of formation of new skin cancers in patients with xeroderma pigmentosum or nevoid basal cell carcinoma syndrome II Determine the possible side effects associated with long-term use of isotretinoin in this patient population
OUTLINE Patients are stratified according to disease type xeroderma pigmentosum vs nevoid basal cell carcinoma syndrome Patients not previously treated with isotretinoin receive oral isotretinoin daily for 2 years and then are followed without receiving isotretinoin for 1 year After the follow-up period treatment may be resumed if the rate of new skin tumor formation reaches 2 per year provided original eligibility criteria are met Treatment may be resumed during the follow-up period if the rate of new skin tumor formation increases to the rate observed before study Patients previously treated with oral isotretinoin continue treatment and are followed to evaluate any long-term effects of treatment
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study
OUTLINE Patients are stratified according to disease type xeroderma pigmentosum vs nevoid basal cell carcinoma syndrome Patients not previously treated with isotretinoin receive oral isotretinoin daily for 2 years and then are followed without receiving isotretinoin for 1 year After the follow-up period treatment may be resumed if the rate of new skin tumor formation reaches 2 per year provided original eligibility criteria are met Treatment may be resumed during the follow-up period if the rate of new skin tumor formation increases to the rate observed before study Patients previously treated with oral isotretinoin continue treatment and are followed to evaluate any long-term effects of treatment
PROJECTED ACCRUAL Approximately 30 patients will be 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 |
|---|---|---|---|
| NCI-91-C-0161 | None | None | None |
| NIAMS-91-AR-0161 | None | None | None |