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:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT01833767
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have a histologic diagnosis of metastatic melanoma. Patients may have received prior systemic therapy or may be previously untreated.
2. Patients must have measurable disease on physical exam or radiologic studies.
3. ECOG performance status of 0 or 1 and estimated survival of at least 3 months.
4. White blood count of \> 3500/mm3, platelet count \> 100,000/mm3, hemoglobin \> 9.0 gm/dl; bilirubin, ALT, AST \< 3 x upper limit of normal; serum creatinine \< 2.0 mg/dl.
5. Patients must undergo a low-level cardiac stress test as a screen for possible atherosclerotic heart disease. Patients with a positive stress test would be excluded from this trial.
6. Patients with elevated temperatures \> 100.5 F must have sources of occult infection excluded.
7. Patients must be felt to have recovered from effects of prior therapy, such as \> 2 weeks after prior chemotherapy.
8. Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
9. Patient consent must be obtained prior to entrance onto study.
Exclusion Criteria:
* 1\. Medical illness requiring corticosteroids or other immunosuppressive agents (such as cyclosporin or methotrexate.
2\. Autoimmune disease such as inflammatory arthritis which could be exacerbated by immune-based therapy.
3\. Prior history of psychiatric disorder which could be exacerbated by interleukin-2.
4\. Lactation or pregnancy.
5\. Evidence of significant cardiovascular disease including history of recent (\< 6 months prior) myocardial infarction, congestive heart failure, primary cardiac arrhythmias (not due to electrolyte disorder or drug toxicity, for example) beyond occasional PVC's, angina, positive low-level stress test, or cerebrovascular accident.
6\. Current untreated brain metastasis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01833767
Study Brief:
Protocol Section:
NCT01833767