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:
NCT00313235
Eligibility Criteria:
Inclusion Criteria:
* Stage M1a, M1b, M1c biopsy proven metastatic melanoma.
* Ages 21-75.
* Karnofsky performance status greater than/equal to 80%.
* Measurable metastatic lesions by physical exam or scans.
* Acceptable CBC and blood chemistry results.
* Adequate hepatic and renal function.
* No active CNS metastatic disease. If CNS history is present, lesions must have been resected by surgery and/or gamma knife irradiation at least 3 months prior to study entry. The total number of CNS lesions at diagnosis should not exceed 3.
* Written informed consent.
Exclusion Criteria:
* Patients that have received more than 8 cycles of chemotherapy for metastatic melanoma.
* Patients who have received chemotherapy less than 4 weeks before beginning the trial.
* Patients who have received IFN alpha-2b or GM-CSF less than 4 weeks before beginning the trial.
* Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial.
* Patients diagnosed with more than 3 CNS metastatic melanoma lesions.
* More than 5 hepatic lesions or any hepatic lesion larger than 5 cm.
* Baseline serum LDH greater than 1.1 times the upper limit of normal.
* Patients who are HIV positive.
* Patients who are pregnant.
* Patients who have receive corticosteroids or other agents less than 4 weeks before beginning the trial.
* Patients with asthma, angina pectoris or congestive heart failure.
* Patients with autoimmune disease such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
* Patients with active infections including viral hepatitis.
* Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT00313235
Study Brief:
Protocol Section:
NCT00313235