Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC)

Not Recruiting

Trial ID: NCT01631331


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

Official Title

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

Stanford Investigator(s)

Sumaira Z. Aasi, MD
Sumaira Z. Aasi, MD

Clinical Professor, Dermatology

Anne Lynn S. Chang, MD
Anne Lynn S. Chang, MD

Professor of Dermatology

Anthony Oro, MD, PhD
Anthony Oro, MD, PhD

Eugene and Gloria Bauer Professor


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

   - 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

Exclusion Criteria:

   - The patient has a history of invasive cancer within the past five years excluding
   non-melanoma skin cancer, stage I cervical cancer, ductal carcinoma in situ of the
   breast, or chronic lymphocytic leukemia (CLL) stage 0

   - The subject has uncontrolled systemic disease, including known human immunodeficiency
   virus (HIV) positive patients:

      - The patient has history of congestive heart failure

      - The patient has clinically important history of liver disease, including viral or
      hepatitis, current alcohol abuse, or cirrhosis

      - The patient has any condition or situation which in the investigator's opinion
      may put the patient at significant risk, could confound the study results, or
      could interfere significantly with the subject's participation in the study; this
      includes history of other skin conditions or disease, metabolic dysfunction,
      physical examination finding, or clinical laboratory finding giving reasonable
      suspicion of a disease or condition that contraindicates use of an
      investigational drug or that might affect interpretation of the results of the
      study or render the patient at high risk from treatment complications

   - The patient has a history of hypersensitivity to any of the ingredients in the study
   medication formulations

   - The patient is willing to abstain from application of non-study topical medications to
   the skin for the duration of the study, including prescription and over the counter
   preparations; for example, topical preparations containing corticosteroids or vitamin
   A derivatives are not allowed

   - Pregnant or nursing patients will be excluded from the study


procedure: Mohs surgery

drug: vismodegib

Not Recruiting

Contact Information

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

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