A Phase II Randomized, Open Label Trial Comparing the Effects of Intermittent Vismodegib Versus PDT on the Maintenance of Benefit Following 7 Months of Continuous Vismodegib Treatment in Patients With Multiple Basal Cell Carcinomas

NCT01556009 Phase 2 COMPLETED Results posted

The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).

Details

Lead sponsor	UCSF Benioff Children's Hospital Oakland
Phase	Phase 2
Status	COMPLETED
Enrolment	24
Start date	2012-04
Completion	2015-12

Conditions

• Basal Cell Nevus Syndrome
• Gorlin's Syndrome

Interventions

• Vismodegib
• Aminolevulinic acid %20 topical solution

Primary outcomes

• Time to Recurrence to Baseline SEB Burden Following 7 Months of Continuous Vismodegib Treatment. — A Data Safety Monitoring Board (DSMB) will review results for an interim analysis when 12 subjects have completed 28 months.
  Primary: i. To compare the efficacy of (i) intermittent vismodegib vs. (ii) the efficacy of photodynamic therapy (PDT) in preventing the return of the burden of surgically eligible BCCs (SEBs) to baseline level following 7 months of continuous vismodegib therapy. ii. To compare the cumulative diameter (burden) of SEBs in patients treated intermittently with vismodegib vs. with photodynamic therapy (PDT).

Countries

United States