Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00006035
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00006035
Study Brief:
Protocol Section:
NCT00006035