C64
Conditions
Interventions
Group 1: One arm study
Sponsors
Medizinische Klinik für Hämatologie, Onkologie
Charité, Campus Virchow
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: -histologically proven renal cell carcinoma -age between 18 and 75 -HLA-A0201-positive patients -adequate performance status -life expectancy over 3 months -interval to last therapy >4 weeks -one evaluable marker lesion -written informed consent
Exclusion criteria
Exclusion criteria: -pregnancy oder nursing, missing contraception -evidence of autoimmune disease -history of severe allergy -systemic corticosteroid therapy or other immunosuppressive therapy -patients with organ allografts -HIV positivity -active infection or severe disease -active brain lesions -impaired renal-, liver - oder hematological function -evidence or history of malignant disease in the past five years -use of unapproved biologic agents (mistletoe, live cells)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Feasibility and safety of the vaccination -Assessment of a specific t-cell response Acute and long-term toxicity will be assesssed by adverse event reports, clinical evaluation and review of laboratoray studies and immunological parameters. The t cell response will be assessed by T cell receptor analysis, ELISPOT assay. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Clinical outcome Clinical outcome will be assessed by clinical examination and CT scans at fixed timepoints. | — |
Countries
Germany
Contacts
Public ContactAnne Flörcken
Charité Campus Virchow-Klinikum Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
Outcome results
None listed