Bleomycin With or Without Electroporation Therapy in Treating Patients With Stage III or Stage IV Melanoma

September 16, 2013 updated by: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ronald C. DeConti, MD, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

June 18, 2004

First Posted (Estimate)

June 21, 2004

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

November 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068050
  • MCC-11883
  • GENETR-EPT-9706001
  • MCC-IRB-5219
  • NCI-G00-1811

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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