Basal Cell Carcinoma Clinical Trial
Official title:
Photodynamic Therapy and Vismodegib for Multiple Basal Cell Carcinomas
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.
Use of PDT for the treatment of BCC Indications for PDT include superficial and nodular BCC.
Eight randomized clinical trials have reported the results of PDT for superficial or nodular
BCC with a total of 1583 patients. Results of the meta analysis showed overall complete
clearance of PDT was 86.4 % compared to 98.2 % for surgery. The 1 year recurrence for PDT was
10.3 % vs 0. 6% for surgery. Cosmetic outcomes were much better with PDT than surgery. (Wang,
2015).
A randomized controlled trial of PDT with MAL versus surgical excision in 196 patients with
superficial BCC showed a 9.3% recurrence rate for PDT versus a 0% recurrence rate for surgery
at 12 months. However, the good-to-excellent cosmetic outcome was 94% and 60% for patients
treated with PDT and surgical excision, respectively. Similarly, in trials of PDT versus
surgery for nodular BCC, recurrence rates are less than 5% for surgery versus 14% to 30% for
PDT with ALA. As with superficial BCC, cosmetic effects are consistently shown to be more
favorable with PDT with ALA (Wang, 2015). In the largest single institution experience with
1440 nodular and superficial BCCs, PDT using systemically administered porfimer sodium showed
an initial (6-month) complete response rate of 92%, with a recurrence rate of less than 10%
at 4 years. At this same institution, a 92% complete response rate was achieved with PDT with
topical ALA in 330 patients with superficial BCC, but the response rate dropped to 71% in 75
patients with nodular BCC.
In a multicenter randomized trial of PDT with MAL versus cryotherapy for superficial BCC,
complete response rates at 3 months were 97% and 95%, respectively, with 5-year recurrence
rates of 22% and 20% for PDT with MAL and cryotherapy, respectively. In this study, the
excellent-to-good cosmetic outcome was 89% for PDT with MAL and 50% for cryotherapy.
Several clinical studies have reported an increase in the initial response rate with a lower
recurrence rate after repeated PDT sessions. Initial responses usually are apparent between
3-6 months after treatment when the skin has healed over and treatment related changes have
resolved. Cycles of MAL PDT repeated after 3 months for persistent BCC has been shown to
offer high and durable response rates. Both efficacy and safety have also been demonstrated
using repeated sessions with red or blue light at follow up times of 3, 6 and 12 months. At
Roswell Park Cancer Institute, Oseroff and colleagues safely used repeated sessions of ALA
PDT in children with BCNS (multiple BCC), and Gilchrest also reported the benefits of ALA PDT
with red light at 2-4 month interval treatments.
The most common adverse event with either ALA or MAL PDT is the burning or stinging pain
experienced by patients during illumination. Zeitouni and colleagues published their
retrospective and prospective data using a 2 step irradiance approach with ALA/MAL PDT and
red light in non BCNS patients with multiple BCC. Follow up times ranged from 6-24 months.
The 2 step irradiance schedule (bilevel) effectively minimized the treatment related pain and
maintained good clinical outcomes (Zeitouni x 2).
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