Melanoma (Skin) Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Electroporation therapy may enhance the ability of chemotherapy
drugs to enter tumor cells. Combining chemotherapy with electroporation therapy may kill
more tumor cells.
PURPOSE: Randomized phase I trial to compare the effectiveness of bleomycin with or without
electroporation therapy in treating patients who have stage III or stage IV melanoma.
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
study.
;
Primary Purpose: Treatment
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