An Open Label Lesion Controlled Study of Electroporation Therapy (EPT) for the Treatment of Cutaneous Metastatic Melanoma Using the Genetronics, Inc. Medpulser System and Bleomycin
OBJECTIVES: I. Compare the objective tumor response rate of patients with stage III or IV
melanoma when treated with intratumoral bleomycin with or without electroporation therapy.
II. Determine the safety of electroporation therapy in these patients. III. Compare the time
to heal with these treatments in these patients. IV. Compare the duration of lesion response
with these treatments in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients receive bleomycin intratumorally on day 1. Arm II: Patients
receive bleomycin intratumorally followed by electroporation therapy intratumorally on day
1. Treatment continues every 4 weeks in the absence of unacceptable toxicity. Patients in
arm I with progressive disease after 1 course of treatment may be crossed over to arm II.
Patients are followed at 4 and 6 months after final treatment.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this
Primary Purpose: Treatment
Ronald C. DeConti, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|