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Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01631331
First Posted: June 29, 2012
Last Update Posted: October 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Jean Yuh Tang, Stanford University
  Purpose
The purpose of this study is to learn about the effect of vismodegib on sporadic basal cell carcinoma (BCCs) prior to surgical removal.

Condition Intervention Phase
Basal Cell Carcinoma of the Skin Recurrent Skin Cancer Drug: vismodegib Procedure: Mohs surgery Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Investigate the Off Label Use of Vismodegib as an Adjuvant to Surgery for Basal Cell Carcinoma Tumors (BCCs)

Resource links provided by NLM:


Further study details as provided by Jean Yuh Tang, Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 15
Study Start Date: June 2012
Study Completion Date: May 31, 2016
Primary Completion Date: September 17, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: vismodegib
Given PO
Other Names:
  • Erivedge
  • GDC-0449
  • Hedgehog antagonist GDC-0449
Procedure: Mohs surgery
Undergo Mohs surgery

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631331


Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Jean Tang Stanford University
  More Information

Responsible Party: Jean Yuh Tang, Associate Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT01631331     History of Changes
Other Study ID Numbers: IRB-24313
NCI-2012-01055 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SKIN0012 ( Other Identifier: OnCore )
First Submitted: June 25, 2012
First Posted: June 29, 2012
Results First Submitted: February 2, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Submitted to Journal of the American Academy of Dermatologists May 2014.
Supporting Materials: Study Protocol
Time Frame: Paper published November 2014, e-publication June 2014 , available indefinitely.
Access Criteria: Paper is available on PubMed. Reprint requests to Jean Yuh Tang, MD PhD, 450 Broadway Street, Redwood City, CA 94063.
URL: https://www.ncbi.nlm.nih.gov/pubmed/24929884

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Skin Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Neoplasms by Site
Skin Diseases