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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006035
First received: July 5, 2000
Last updated: September 16, 2013
Last verified: November 2000

July 5, 2000
September 16, 2013
June 2000
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Complete list of historical versions of study NCT00006035 on ClinicalTrials.gov Archive Site
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Bleomycin With or Without Electroporation Therapy in Treating Patients With Stage III or Stage IV Melanoma
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.

Interventional
Phase 1
Primary Purpose: Treatment
Melanoma (Skin)
  • Biological: bleomycin sulfate
  • Drug: electroporation therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006035
CDR0000068050, MCC-11883, GENETR-EPT-9706001, MCC-IRB-5219, NCI-G00-1811
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H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study Chair: Ronald C. DeConti, MD H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
November 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP