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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
Rockefeller University
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | 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
