Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC)
|ClinicalTrials.gov Identifier: NCT01631331|
Recruitment Status : Completed
First Posted : June 29, 2012
Results First Posted : October 2, 2017
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma of the Skin Recurrent Skin Cancer||Drug: vismodegib Procedure: Mohs surgery||Early Phase 1|
I. The percent reduction in surgical defect area/size surrounding BCC tumor pre and post-vismodegib.
I. Recurrence rate post treatment II. Safety, tolerability and percent drop-out after 3 vs. 6 months of vismodegib in otherwise healthy patients.
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Investigate the Off Label Use of Vismodegib as an Adjuvant to Surgery for Basal Cell Carcinoma Tumors (BCCs)|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||September 17, 2015|
|Actual Study Completion Date :||May 31, 2016|
Experimental: Treatment (vismodegib and Mohs surgery)
Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.
Other Names:Procedure: Mohs surgery
Undergo Mohs surgery
- Percent Change in Surgical Defect Area After the Treatment Period Using Calipers and Photographs Was Calculated [ Time Frame: average of 4 months ]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.
- Number of Tumors Demonstrating Histologic Cure [ Time Frame: Average of 4 months ]Determination of histologic cure (no residual BCC on the ﬁrst piece of excised tissue) post serial sectioning of parafﬁn embedded Mohs specimens
- Tumor Recurrence Rate of Treated BCCs [ Time Frame: average of 22 months ]Recurrence rate of BCCs during a 22 month average (range 12 to 28 months) follow up period.
- Tumor Size Measurements Before and After Short Term Vismodegib Treatment [ Time Frame: 4 months (average) ]We measured the length and width of all tumors (target and non-target) before and after vismodegib treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631331
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Jean Tang||Stanford University|