Eligibility Module

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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 @ 11:32 PM
Ignite Modification Date: 2025-12-24 @ 11:32 PM
NCT ID: NCT00003556
Eligibility Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed melanoma that is surgically incurable * At least one dermal, subcutaneous or lymph node metastasis that is evaluable for local response and accessible for injection * If only one accessible lesion is available, it must be at least 2 cm * If two or more accessible lesions exist, then none of them are required to be at least 2 cm PATIENT CHARACTERISTICS: * Age: Over 18 * Performance status: ECOG 0-2 * Life expectancy: Greater than 3 months * Leukocyte count at least 3,000/mm3 * Platelet count at least 120,000/mm3 * SGOT and alkaline phosphatase less than 5 times normal * Bilirubin less than 1.5 mg/dL (unless secondary to hepatic metastasis) * BUN less than 40 mg/dL * Creatinine less than 2.5 mg/dL * No evidence of congestive heart failure, unstable angina, or serious cardiac arrhythmias * Not positive for hepatitis B virus * Not positive for HIV * No history of allergy to vaccinia virus * No evidence of other primary tumors except for basal cell carcinoma, squamous cell skin carcinoma, or carcinoma in situ of the cervix * Not pregnant or nursing * Fertile patients must use effective contraception * No underlying immunodeficiency disorder PRIOR CONCURRENT THERAPY: * At least 30 days since prior biologic therapy (e.g., interferon or IL-2) * At least 30 days since prior chemotherapy * No concurrent steroids * At least 30 days since prior radiotherapy * Prior radiotherapy to no greater than 50% of nodal groups * No prior splenectomy * No concurrent drugs which affect immune function (e.g., glucocorticoids or cimetidine)
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT00003556
Study Brief:
Protocol Section: NCT00003556