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

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bleomycin sulfate
electroporation therapy
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
September 16, 2013
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006035
Brief Title
Bleomycin With or Without Electroporation Therapy in Treating Patients With Stage III or Stage IV Melanoma
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 Type
Interventional

2. Study Status

Record Verification Date
November 2000
Overall Recruitment Status
Unknown status
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bleomycin sulfate
Intervention Type
Drug
Intervention Name(s)
electroporation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald C. DeConti, MD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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

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