Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC)

NCT ID: NCT01631331

Last Updated: 2017-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-05-31

Brief Summary

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

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.

Conditions

Basal Cell Carcinoma of the Skin; Recurrent Skin Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

vismodegib

Intervention Type: DRUG

Given PO

Mohs surgery

Intervention Type: PROCEDURE

Undergo Mohs surgery

Interventions

vismodegib

Given PO

Intervention Type: DRUG

Mohs surgery

Undergo Mohs surgery

Intervention Type: PROCEDURE

Other Intervention Names

Erivedge; GDC-0449; Hedgehog antagonist GDC-0449

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Jean Yuh Tang

Associate Professor of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean Tang

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

References

Ally MS, Aasi S, Wysong A, Teng C, Anderson E, Bailey-Healy I, Oro A, Kim J, Chang AL, Tang JY. An investigator-initiated open-label clinical trial of vismodegib as a neoadjuvant to surgery for high-risk basal cell carcinoma. J Am Acad Dermatol. 2014 Nov;71(5):904-911.e1. doi: 10.1016/j.jaad.2014.05.020. Epub 2014 Jun 11.

Reference Type: RESULT

PMID: 24929884 (View on PubMed)

Other Identifiers

NCI-2012-01055

Identifier Type: REGISTRY

Identifier Source: secondary_id

SKIN0012

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-24313

Identifier Type: -

Identifier Source: org_study_id