Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Carcinoma

Recurrence

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Basal Cell

Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.

vismodegib

Mohs surgery

Jean Tang

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.

Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC)

A Pilot Study to Investigate the Off Label Use of Vismodegib as an Adjuvant to Surgery for Basal Cell Carcinoma Tumors (BCCs)

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.

Determination of histologic cure (no residual BCC on the ﬁrst piece of excised tissue) post serial sectioning of parafﬁn embedded Mohs specimens

Recurrence rate of BCCs during a 22 month average (range 12 to 28 months) follow up period.

We measured the length and width of all tumors (target and non-target) before and after vismodegib treatment.

National Cancer Institute (NCI)

University Hospitals Cleveland Medical Center

Stanford University

Associate Professor of Dermatology

We evaluated patients monthly for skin examinations and adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4).

Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma and then undergo Mohs surgery.

vismodegib: Given PO

Mohs surgery: Undergo Mohs surgery

Treatment (Vismodegib and Mohs Surgery)

Only patients who were treated with vismodegib for an average of 4 months were included in our analysis.

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

We enrolled patients with at least 1 biopsy-conﬁrmed BCC of any histologic subtype, more than 5 mm in diameter, eligible for surgical removal. Only patients who were treated with vismodegib for an average of 4 months were included in our analysis.

Dr. Gina Kwon

Only patients who were treated with vismodegib for an average of 4 months were included in our analysis. Only target tumors are included in this analysis.

Percent Change in Surgical Defect Area After the Treatment Period Using Calipers and Photographs Was Calculated

Patients each had 1 to 2 target BCCs identified at baseline for surgical excision and were treated with vismodegib for an average of 4 months. Only target lesions are included in this analysis.

Number of Tumors Demonstrating Histologic Cure

11 patients completed the trial and 13 target BCCs were excised.

Tumor Recurrence Rate of Treated BCCs

Patients receive vismodegib PO daily for 3-6 months based on the size of basal cell carcinoma.

vismodegib: Given PO

Mohs surgery: Undergo Mohs surgery

6 of the 11 patients who completed the study had multiple BCCs. We followed 13 target BCCs and 30 non-target BCCs for potential tumor size change from these patients.

Spots Global Cancer Trial Database for Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC)

Trial Identification

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Interventions

Study Description

Keywords

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