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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 : Active, not recruiting
First Posted : May 6, 2015
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: VISmodegib for ORbital and Periocular Basal Cell Carcinoma (VISORB)
Study Start Date : May 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vismodegib

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



Primary Outcome Measures :
  1. The number of patients with a score of 21 or greater by the Visual Assessment Weighted Score (VAWS). [ Time Frame: Up to 15 months after start of study treatment ]
    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. Patients will be assessed at 1 year after start of study treatment or 2 (+/- 1) months after tumor excision/debulking surgery, whichever is longer.


Secondary Outcome Measures :
  1. Number of patients with progressive disease (PD) [ Time Frame: Up to 15 months after start of study treatment ]
    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: Up to 15 months after start of study treatment ]
    Treatment response will be determined per RECIST, using clinical measurements and/or tumor imaging measurements (determined by treating physician). Tolerance will be self-reported by patient.

  3. Number of patients with a complete response (CR), partial response (PR) or stable disease (SD) AND poor tolerance of vismodegib [ Time Frame: Up to 15 months after start of study treatment ]
    Treatment response will be determined per RECIST, using clinical measurements and/or tumor imaging measurements (determined by treating physician). Tolerance will be self-reported by patient.



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.

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: Alon Kahana, M.D., Ph.D. University of Michigan

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
Last Update Posted: December 9, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell