Bleomycin With or Without Electroporation Therapy in Treating Patients With Stage III or Stage IV Melanoma
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.
Biological: bleomycin sulfate
Drug: electroporation therapy
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||June 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006035
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Study Chair:||Ronald C. DeConti, MD||H. Lee Moffitt Cancer Center and Research Institute|