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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01456104
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of melanoma, AJCC stage IIB, IIC, III, or IV (MIa), with histologic confirmation by the Department of Pathology at MSKCC.
* Patients must be HLA-A\*0201 positive, based on high resolution DNA level typing.
* Expected survival of greater than 3 months.
* Karnofsky performance status of 70 or higher
* All patients should have undergone surgical treatment appropriate to their stage of disease
* Patients may not have received chemotherapy, immunotherapy, or radiation within a minimum of 28 days (minimum of 42 days for nitrosoureas or mitomycin) before participation in this protocol.
Exclusion Criteria:
* Pregnant or lactating women because of unknown risks to the fetus or infant.
* Patients requiring systemic corticosteroids or comparable exogenous immunosuppressive agent(s) (no exclusion for use of NSAIDs).
* Patients with a known immunodeficiency (e.g., infection with HTLV-1,2, HIV-1,2; etc.).
* Patients with coexisting autoimmune diseases, except vitiligo.
* Patients with baseline impairments of hematologic, hepatic, or renal function (CTCAE v4.0 \> grade 1, ANC \< 1500, hgb \< 10.0 g/dl, plts \< 75,000/ul, AST \> 3x ULN, creatinine \> 1.5xULN), all assessed within four weeks of study entry.
* Patients with organ allografts.
* Patients who are status post splenectomy or status post splenic irradiation.
* Patients with a history of documented pre-existing retinal/choroidal disease.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT01456104
Study Brief:
Protocol Section:
NCT01456104