None listed
Conditions
Brief summary
The purpose of this study is to determine the effects of oral Vismodegib as an adjuvant treatment in periocular basal cell carcinoma. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with periocular basal cell carcinoma. Study details All participants in this study will receive the treatment of Vismodegib once daily. This medication will be subsidised by PBS for participants. Prior to commencing treatment, female participants will require a pregnancy test and a punch biopsy of the tumour will be taken in all cases. You may require additional blood tests prior to commencing the treatment medication, no additional scans or investigations will be required outside of standard practice for this trial. It is hoped that this research will demonstrated a reduction in the surface area of skin removed by wide surgical excision following neo-adjuvant use of Vismodegib for periocular basal cell carcinoma and improved surgical outcomes for patients.
Interventions
Vismodegib 150 milligram Capsules
Orally
Once Daily for 6 months
Adherence monitored at 1, 3 and 6 monthly clinical appointments
Drug adherence will be monitored by audit of participant diary and 3 month prescribing follow-up
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female aged greater than or equal to 18 years of age with histopathologically confirmed basal cell carcinoma of the periocular skin 2. Able to participate and willing to provide written consent including consent for photographs prior to performance of study-related procedures and to comply with the study protocol 3. Willingness to delay excision of the target tumour site until the time mandated in the protocol, unless evidence of disease progression or lack of drug tolerability 4. Patients must be naïve to Vismodegib and other hedgehog pathway inhibitors 5. Willingness to undergo histopathologic confirmation by with 3mm punch biopsy 6. Female patients of child-bearing age must agree to use 2 reliable forms of contraception including one highly effective method and a barrier method during treatment and for 27months after final dose 7. Breast feeding is not allowed during the treatment and for at least 7 months after completion of study therapy 8. Negative serum pregnancy test within 7 days prior to commencement of dosing in women of child-bearing potential 9. Male patients with partners of child-bearing potential must always use a condom even after vasectomy, during treatment with study medication and for at least 2 months after the final dose 10. Men must agree not to donate sperm during treatment and for 2 months after discontinuation of therapy 11. Agreement not to donate blood or blood products during the study period and for at least 7 months after discontinuation 12. Absence of psychological, familial, sociological, or geographical condition that potentially hampers compliance with the study protocol and follow-up as defined by the treatment discontinuation schedule
Exclusion criteria
1. Age <18 years 2. Inability or unwillingness to comply with study and follow-up procedures 3. History of prior treatment with Vismodegib or any hedgehog pathway inhibitor 4. Known hypersensitivity to Vismodegib 5. Inability or unwillingness to swallow capsules 6. History of malabsorption or other condition that would interfere with absorption of orally delivered study drug 7. Pregnant, lactating or breast-feeding women 8. Participation in another clinical study within 28 days before registration 9. Uncontrollable medical illness, including advanced malignancies 10. History of other condition that would affect interpretation of study results 11. Current severe, uncontrolled systemic illness 12. Any medical or psychological illness preventing adequate consent of ability to comply with the study protocol 13. Patients with one of the following rate hereditary conditions: galactose intolerance, primary hypolactasia, or glucose-galactose malabsorption 14. Known or suspected alcohol or drug abuse 15. Unfit for surgical intervention
Outcome results
None listed