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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

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
study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV melanoma Progressive
disease defined by: Stage III Inoperable due to number of lesions (greater than 5 nodules)
OR Recurrence after surgical excision Stage IV Failed to respond to immunotherapy or
chemotherapy OR Immunotherapy or chemotherapy contraindicated Bidimensionally measurable
disease At least 2 lesions accessible to electroporation electrode

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Greater than 6 months Hematopoietic: Not specified Hepatic: Not specified
Renal: Creatinine clearance at least 35 mL/min Cardiovascular: No cardiac pacemakers or
implantable defibrillators No history of severe cardiac arrhythmia No myocardial
infarction in past 6 months Pulmonary: No significant pulmonary fibrosis or other severe
pulmonary pathology Other: Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception No clinical or bacteriological evidence of
active infection No known hypersensitivity to bleomycin including shock, uncontrolled
hypothermia, prurit or prurit type toxidermia, Raynaud's syndrome, or digital gangrene No
known sensitivity to lidocaine

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Concurrent
systemic immunotherapy allowed if disease is stable or progressing at time of study entry
after at least 8 weeks of treatment Chemotherapy: See Disease Characteristics At least 12
weeks since prior intralesional chemotherapy Concurrent systemic chemotherapy allowed if
disease is stable or progressing at time of study entry after at least 8 weeks of
treatment Must not have previously exceeded or will exceed on this study a cumulative dose
greater than 400 U of bleomycin Endocrine therapy: Not specified Radiotherapy: At least 12
weeks since prior local radiotherapy to study lesion Surgery: See Disease Characteristics
At least 12 weeks since prior local surgery to study lesion Other: At least 12 weeks since
prior local cryotherapy to study lesion At least 4 weeks since prior investigational drugs
or devices No other concurrent investigational study

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ronald C. DeConti, MD

Investigator Role:

Study Chair

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068050

NCT ID:

NCT00006035

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612