The purpose of this study is to learn about the effect of vismodegib on sporadic basal cell carcinoma (BCCs) prior to surgical removal.
PRIMARY OBJECTIVES: I. The percent reduction in surgical defect area/size surrounding BCC tumor pre and post-vismodegib. SECONDARY OBJECTIVES: I. Recurrence rate post treatment II. Safety, tolerability and percent drop-out after 3 vs. 6 months of vismodegib in otherwise healthy patients. OUTLINE: Patients receive vismodegib orally (PO) once daily (QD) for up to 3 months if the initial BCC size is \< 2 cm and superficial or for up to 6 months if the initial BCC size is \>= 2 cm or non-superficial. After completion of vismodegib treatment, patients undergo Mohs surgery. After completion of study treatment, patients are followed up for an average of 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Given PO
Undergo Mohs surgery
Stanford University
Stanford, California, United States
Percent Change in Surgical Defect Area After the Treatment Period Using Calipers and Photographs Was Calculated
At baseline, we selected 1 to 2 tumors per patient for surgery (13 target tumors selected). At baseline,1 Mohs surgeon measured the estimated surgical defect area around the target tumor. For tumors to be excised by Mohs we defined estimated surgical defect as the tumor size plus a 2-mm circumferential margin, presuming tumor clearance after a Mohs stage-1 excision. For the tumor undergoing standard (non-Mohs) excision, we used tumor size plus a standard 4-mm margin11 for the estimated surgical defect. On the day of the surgery, we measured the surgical defect area as the final tumor-free defect after the Mohs procedure or non-Mohs excision immediately before closure. We used the Image J software program (National Institutes of Health, Bethesda, MD) to calculate tumor area (cm2). Only target tumors are included in this analysis.
Time frame: average of 4 months
Number of Tumors Demonstrating Histologic Cure
Determination of histologic cure (no residual BCC on the first piece of excised tissue) post serial sectioning of paraffin embedded Mohs specimens
Time frame: Average of 4 months
Tumor Recurrence Rate of Treated BCCs
Recurrence rate of BCCs during a 22 month average (range 12 to 28 months) follow up period.
Time frame: average of 22 months
Tumor Size Measurements Before and After Short Term Vismodegib Treatment
We measured the length and width of all tumors (target and non-target) before and after vismodegib treatment.
Time frame: 4 months (average)
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