Non-melanomatous Skin Cancer Clinical Trial
Official title:
In Vivo and In Vitro Pharmacology of Sirolimus in Subjects With Basal Cell Nevus Syndrome
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.
OBJECTIVES:
Primary
- Compare messenger RNA and protein expression patterns in patients with basal cell nevus
syndrome (BCNS) vs in cultured cells of healthy participants (control) before treatment
to identify a set of genes that are differentially expressed in BCNS.
- Assess the effects of topical sirolimus on gene expression (genes identified in the
primary objective) in vivo using keratinocytes, fibroblasts, and lymphocytes from
patients with BCNS and from healthy participants (controls) by targeted expression
methods.
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.
;
Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT00423397 -
Gefitinib and PEG-Interferon Alfa-2a in Treating Patients With Unresectable or Metastatic Skin Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT00103246 -
Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides
|
Phase 1 | |
| Active, not recruiting |
NCT00391300 -
Bioelectric Field Imaging in Diagnosing Melanoma and Other Skin Cancers in Patients With Skin Lesions
|
Phase 1 | |
| Completed |
NCT00066872 -
Topical Imiquimod Compared With Surgery in Treating Patients With Basal Cell Skin Cancer
|
Phase 3 | |
| Completed |
NCT00002963 -
Photodynamic Therapy in Treating Patients With Skin Cancer
|
Phase 2 | |
| Completed |
NCT00021294 -
Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis
|
Phase 2 | |
| Completed |
NCT00003611 -
Acitretin in Preventing Skin Cancers in Patients With Previously Treated Skin Cancers Who Have Undergone Organ Transplantation
|
N/A | |
| Terminated |
NCT00663910 -
Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
|
Phase 0 | |
| Recruiting |
NCT00295906 -
Computer-Based Continuing Education for Doctors in Examination and Counseling of Patients on Skin Cancer or Weight Control
|
N/A | |
| Completed |
NCT00025012 -
Isotretinoin in Preventing Skin Cancer
|
N/A | |
| Completed |
NCT00021125 -
Radiation Therapy in Treating Patients With Head and Neck Cancer
|
Phase 3 | |
| Completed |
NCT00601640 -
Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
|
Phase 2 | |
| Completed |
NCT00079300 -
Imiquimod Cream in Treating Patients With Basal Cell Skin Cancer
|
Phase 1 | |
| Completed |
NCT00017485 -
Photodynamic Therapy in Treating Patients With Basal Cell Skin Cancer
|
Phase 1 | |
| Recruiting |
NCT00747903 -
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Skin Cancer
|
Phase 2 | |
| Terminated |
NCT00899132 -
Studying a Tumor Marker for Testicular Cancer, Skin Cancer, Small Intestine Cancer, and Pancreatic Cancer
|
N/A | |
| Completed |
NCT00099112 -
Effect of Solar-Simulated Ultraviolet Radiation on Gene Expression in Unprotected and Sunscreen-Protected Skin of Healthy Adults With Fitzpatrick Skin Type II
|
N/A | |
| Completed |
NCT00644384 -
Acitretin in Preventing Skin Cancer in Patients at High Risk for Skin Cancer
|
N/A | |
| Completed |
NCT00023621 -
Celecoxib in Preventing Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome
|
Phase 2 | |
| Completed |
NCT00002975 -
Photodynamic Therapy in Treating Patients With Skin Cancer
|
Phase 2 |