Clinical Trials /

VISmodegib for ORbital and Periocular Basal Cell Carcinoma

NCT02436408

Description:

Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care. Patients with tumors that do not respond to treatment with Vismodegib, and those who have a good response but poor tolerance of Vismodegib, will be offered surgical excision of the tumor. Patients with a good response and good tolerance of Vismodegib may continue the treatment as long as clinically indicated.

Related Conditions:
  • Basal Cell Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: VISmodegib for ORbital and Periocular Basal Cell Carcinoma
  • Official Title: VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)

Clinical Trial IDs

  • ORG STUDY ID: UMCC 2014.022
  • SECONDARY ID: HUM00082579
  • NCT ID: NCT02436408

Conditions

  • Carcinoma, Basal Cell

Interventions

DrugSynonymsArms
VismodegibVismodegib

Purpose

Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat. Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care.

Trial Arms

NameTypeDescriptionInterventions
VismodegibExperimental150mg taken orally once daily
  • Vismodegib

Eligibility Criteria

        Inclusion Criteria:

          -  Adult patients over 18 years of age with locally advanced or recurrent orbital or
             periorbital basal cell carcinoma (BCCA), or a medial canthal BCCA that threatens the
             lacrimal drainage system.

          -  Clinical assessment score obtained at baseline.

          -  Medical Oncology screening performed at baseline.

          -  Adequate BCCA size and location.

          -  Adequate hematopoietic capacity, hepatic and renal function.

          -  Male patients must agree to use condoms during treatment and for 2 months after last
             dose.

          -  Male patients must agree to not donate sperm during treatment and for 2 months after
             last dose.

          -  Participant must agree not to donate blood during the study and for 7 months after
             last dose.

          -  Informed consent signed.

          -  Patient must consent to blood biomarker analysis.

          -  Patient must be able to be present for monthly visits for the duration of the study.

        Exclusion Criteria:

          -  Inability or unwillingness to swallow capsules.

          -  Inability or unwillingness to comply with study procedures.

          -  Pregnant, lactating, or breast feeding women.

          -  Women of childbearing potential.

          -  Uncontrolled medical illness.

          -  Age under 18 years.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The number of patients with a score of 21 or greater by the Visual Assessment Weighted Score (VAWS) at 1 year
Time Frame:1 year
Safety Issue:
Description:The VAWS was developed for the purpose of this study. It is made up of standard ophthalmic exam points, as well as subjective assessment of tearing and overall patient satisfaction. The maximum score is 50 and a score of 21 or greater will be considered a good outcome

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Michigan Cancer Center

Last Updated

September 13, 2016