Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas
Status:
Completed
Trial end date:
2017-11-18
Target enrollment:
Participant gender:
Summary
This is a Phase 1 single site study to evaluate the safety and efficacy of a combination
therapy that includes the administration of vismodegib and photodynamic therapy (PDT) using
aminolevulinic acid (20 percent ALA) for multiple basal cell carcinomas. All subjects will
receive vismodegib 150mg by mouth every day for 3 months, and undergo three PDT sessions with
topical application of ALA. The PDT will be first administered at 7+ 4 business days after
the beginning of the Erivedge and at 45 + 5 business days and then at 90 + 10 business days.
Primary Objective The primary objective of this study is to determine the safety of
photodynamic therapy (PDT) with vismodegib (combination therapy) for patients with multiple
BCC.
3.2 Secondary Objective To evaluate the overall response rate (ORR) to the combination
therapy in patients with multiple BCCs.ORR is defined as the proportion of evaluable study
subjects who has complete or partial response to the study treatment.