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VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)

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.
 
ClinicalTrials.gov Identifier: NCT02436408
Recruitment Status : Completed
First Posted : May 6, 2015
Results First Posted : October 28, 2021
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell Drug: Vismodegib Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)
Actual Study Start Date : July 15, 2015
Actual Primary Completion Date : September 2020
Actual Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vismodegib
150mg taken orally once daily
 Drug: Vismodegib


Outcome Measures
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Primary Outcome Measures :
  1. The Number of Patients With a Score of 21 or Greater by the Visual Assessment Weighted Score (VAWS). [ Time Frame: Until end of study treatment (up to 15 months after start of study treatment); treatment duration ranged from 53 - 386 days. ]
    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.


Secondary Outcome Measures :
  1. Number of Patients With Progressive Disease (PD) [ Time Frame: Until end of study treatment (up to 15 months after start of study treatment); treatment duration ranged from 53 - 386 days. ]
    Treatment response will be determined per Response Evaluation Criteria in Solid Tumors (RECIST) protocol, using clinical measurements and/or tumor imaging measurements (determined by treating physician).

  2. Number of Patients With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) AND Good Tolerance of Vismodegib [ Time Frame: Until end of study treatment (up to 15 months after start of study treatment); treatment duration ranged from 53 - 386 days. ]
    Tolerance will be self-reported by patient. Treatment response will be determined per Response Evaluation Criteria in Solid Tumors (RECIST) protocol, using clinical measurements and/or tumor imaging measurements (determined by treating physician).

  3. Number of Patients With a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) AND Poor Tolerance of Vismodegib [ Time Frame: Until end of study treatment (up to 15 months after start of study treatment); treatment duration ranged from 53 - 386 days. ]
    Tolerance will be self-reported by patient. Treatment response will be determined per Response Evaluation Criteria in Solid Tumors (RECIST) protocol, using clinical measurements and/or tumor imaging measurements (determined by treating physician).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 3 months after last dose.
  • Male patients must agree to not donate sperm during treatment and for 3 months after last dose.
  • Participant must agree not to donate blood during the study and for 7 months after last dose.
  • Informed consent signed.
  • If the patient consents to enroll, then blood will be drawn and stored for biomarker analysis.

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.
  • Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
  • Age under 18 years.
Contacts and Locations
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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): NCT02436408


Locations
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United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
Investigators
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Principal Investigator: Cagri Besirli, M.D., Ph.D. University of Michigan
  Study Documents (Full-Text)

Documents provided by University of Michigan Rogel Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] June 11, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT02436408    
Other Study ID Numbers: UMCC 2014.022
HUM00082579 ( Other Identifier: University of Michigan )
First Posted: May 6, 2015    Key Record Dates
Results First Posted: October 28, 2021
Last Update Posted: October 28, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell