Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma
- 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
- 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.
- 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;
- 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.