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

The purpose of this study is to learn about the effect of vismodegib on sporadic basal cell carcinoma (BCCs) prior to surgical removal.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : vismodegib
  • procedure : Mohs surgery

Phase: N/A

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Study patients must have at least one BCC, > 5 mm, eligible for Mohs surgical removal; patients with BCCs that have been treated before (recurrent BCCs, BCCs that failed other chemotherapy) are eligible for this trial, if they meet size criteria - No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will be employed - Normal hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x the upper limit of normal (ULN) - Normal renal function : normal serum creatinine defined as <= 2.5 mg/dL - Clinically acceptable complete blood count (CBC) - Ability to understand and the willingness to sign a written informed consent document - The patient is willing to forego surgical treatment of BCCs by up to 6 months, except when the principal investigator (PI) believes that delay in treatment potentially might compromise the health of the subject - Documented negative serum pregnancy test for women of childbearing potential, with agreement to the use of two acceptable methods of contraception during the study and for 7 months after discontinuation of vismodegib - For men with female partners of childbearing potential, agreement to use a latex, non-latex, or any other male condom and to advise their female partners to use an additional acceptable method of birth control during the study and for 2 months after discontinuation of study drug - Be willing to not donate blood or semen for three months following discontinuation of study medications

External Links

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Contact information

Primary Contact:

Irene Bailey 650-721-7149

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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