title: Phase I/II trial for the treatment of cutaneous and subcutaneous tumors using electrochemotherapy.
abstract: BACKGROUND
  Electroporation is a process that causes a transient increase in the permeability of cell membranes. It can be used to increase the intracellular concentration of chemotherapeutic agents in tumor cells (electrochemotherapy; ECT). A clinical study was initiated to determine if this mode of treatment would be effective against certain primary and metastatic cutaneous malignancies. A group of six patients, three with malignant melanoma, two with basal cell carcinoma, and one with metastatic adenocarcinoma, were enrolled in the study. the treatment was administered in a two-step process.
  
  
  METHODS
  Each patient received a 10 unit/m2 dose of bleomycin administered intravenously at 1 to 1.5 units/minute. This was followed by eight 99 microsecond pulses at an amplitude of 1.3 kV/cm administered directly to the tumors 5 to 15 minutes after the bleomycin was completely infused. Pulses were administered after the injection of 1% lidocaine solution around the treatment site.
  
  
  RESULTS
  Two of three melanoma patients had objective responses. In these two patients, five of six treated tumors decreased in size, and three completely responded. Untreated tumors displayed continued growth. Objective responses were observed in both basal cell carcinoma (BCC) patients. One patient had partial responses in both treated tumors. The other patient had one of four primary BCCs respond completely, and the remaining three respond partially. Patients with metastatic breast adenocarcinoma showed complete responses in both treated nodules after ECT. All patients tolerated the treatment well with no residual effects from the electric pulses.
  
  
  CONCLUSIONS
  ECT was an effective local treatment in the majority of nodules treated. The results thus far are very encouraging and the study is being continued.
authors.affiliation: Department of Surgery, College of Medicine, University of South Florida, Tampa 33612-4799, USA.
authors.forename: R
authors.initials: R
authors.lastname: Heller
authors.forename: M J
authors.initials: MJ
authors.lastname: Jaroszeski
authors.forename: L F
authors.initials: LF
authors.lastname: Glass
authors.forename: J L
authors.initials: JL
authors.lastname: Messina
authors.forename: D P
authors.initials: DP
authors.lastname: Rapaport
authors.forename: R C
authors.initials: RC
authors.lastname: DeConti
authors.forename: N A
authors.initials: NA
authors.lastname: Fenske
authors.forename: R A
authors.initials: RA
authors.lastname: Gilbert
authors.forename: L M
authors.initials: LM
authors.lastname: Mir
authors.forename: D S
authors.initials: DS
authors.lastname: Reintgen
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000378:metabolism / Q000628:therapy*; D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001761:Bleomycin / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002280:Basal Cell Carcinoma / Q000188:drug therapy / Q000378:metabolism / Q000628:therapy*; D002463:Cell Membrane Permeability / Q000502:physiology; D004594:Electrophysiology; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000378:metabolism / Q000628:therapy*; D008875:Middle Aged; D012878:Skin Neoplasms / Q000188:drug therapy / Q000378:metabolism / Q000628:therapy*; D004561:Transcutaneous Electric Nerve Stimulation / Q000009:adverse effects
chemical_list: D000903:Antibiotics, Antineoplastic; D001761:Bleomycin