|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Topical Sirolimus in Patients With Basal Cell Nevus Syndrome and in Healthy Participants | ||||
| Official Title † | In Vivo and In Vitro Pharmacology of Sirolimus in Subjects With Basal Cell Nevus Syndrome | ||||
| Brief Summary | RATIONALE: Studying samples of blood and tissue from patients with basal cell nevus syndrome and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to basal cell nevus syndrome. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of sirolimus may keep basal cell skin cancer from forming in patients with basal cell nevus syndrome. PURPOSE: This phase I trial is studying topical sirolimus in patients with basal cell nevus syndrome and in healthy participants. |
||||
| Detailed Description | OBJECTIVES: Primary
OUTLINE: Patients and healthy participants receive topical sirolimus ointment twice daily for 12 weeks. Blood and skin biopsies are obtained at baseline and at week 12 for gene and protein expression studies. Alterations in RNA are measured by microarray analysis. Alterations in protein expression are measured by 2-dimensional gel electrophoresis and matrix-assisted laser desorption ionization time-of-flight mass spectrometry. After completion of study therapy, patients and healthy participants are followed at 4 weeks. PROJECTED ACCRUAL: A total of 16 patients and healthy participants will be accrued for this study. |
||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Open Label | ||||
| Primary Outcome Measure † | Alterations in RNA as measured by microarray analysis [ Designated as safety issue: No ] Alterations in protein expression as measured by 2-dimensional gel electrophoresis and matrix-assisted laser desorption ionization time-of-flight mass spectroscopy [ Designated as safety issue: No ] |
||||
| Secondary Outcome Measure † | |||||
| Condition † | Neoplastic Syndrome Non-Melanomatous Skin Cancer |
||||
| Intervention † | Drug: sirolimus Procedure: biopsy Procedure: comparative genomic hybridization Procedure: gene expression analysis Procedure: gene expression profiling Procedure: laboratory biomarker analysis Procedure: mass spectrometry Procedure: protein expression analysis Procedure: proteomic profiling |
||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 16 | ||||
| Start Date † | |||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00433485 | ||||
| Organization ID | CDR0000522464 | ||||
| Secondary IDs †† | YALE-HIC-26866 | ||||
| Study Sponsor † | Yale University | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2007 | ||||
| First Received Date † | February 8, 2007 | ||||
| Last Updated Date | July 23, 2008 | ||||