Status:
COMPLETED
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
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Rockefeller University
Conditions:
Melanoma
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
This study is being done to see if the investigators can help the immune system to work against melanoma. A dendritic cell is another type of white blood cell. It has most, if not all, of the protein...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 12 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01456104
Start Date
October 17 2011
End Date
January 12 2023
Last Update
January 13 2023
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065