C64
Conditions
Interventions
Group 1: allogeneic genetically modified tumor cell vaccine RCC-26/CD80/IL-2
Sponsors
Ludwig-Maximilians-Universität München
Labor für Tumorimmunologie, LIFE-Zentrum
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: - Histologically proven metastatic renal cell carcinoma (stage IV Holland/Robson) - Patients must be HLA-A*0201 - ECOG 0-1 - Life expectancy > 3 months - Age > 18 y. and < 75y. - Interval between the last therapy course and enrollment in the study should be at least 3 months - Interval between surgery and enrollment in the study should be at least 4 weeks - At least one evaluable marker lesion other than bone or brain metastases should be present - Written informed consent
Exclusion criteria
Exclusion criteria: - Pregnancy or nursing - Anamnestic, clinical or laboratory evidence of active autoimmune disease - History of severe allergy - Systemic corticosteroid therapy or other immunosuppressive therapy - Patients with organ allografts - HIV positivity - Active systemic infection or other major medical illness, including severe heart disease, severe respiratory diseases or nervous system disorders. - Active brain metastatic lesions - Serum creatinine > 2.5 mg /dl - Bilirubin > 3.0 mg /dl, Transaminases > 100 U/L - WBC < 2500 / mm^3, hemoglobin < 7.5 g /dl or platelets < 100.000 / mm^3 - Evidence or history of other malignant tumor in the previous 5 years - Use of unapproved biologic agents such as mistletoe extracts, live cells, live-cell extracts or other immune activating agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and toxicity: Safety and toxicity of the vaccine treatment will be assessed by adverse event reports starting from the first vaccination up to 3 months after the last of 10 vaccinations. Adverse event reports will be based on spontaneous reports, on patients history and on physical examinations including vital capacity, 12-lead resting ECG, general auto-antibodies (anti-nuclear, anti-mytochondrial, anti-thyroid antibodies), anti-allogeneic response (anti-HLA antibodies), on standard laboratory tests and on determination of the DTH (delayed-type of hypersensitivity)-reactivity. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement of the clinical situation: Computer tomography pre vaccination and at the time points of the 4th, and 8th vaccination to evaluate whether clinical improvement is detectable at the end of the vaccination schedule and 3 months after treatment completion by accurate staging of patient’s disease manifestations. The patients will be further followed-up for 5 years or up to further therapy requirements or up to death. 2. Development of an immune response: - by analysing the infiltrate at the injection site (biopsy: histology, flow cytometry) 48 hrs after the 4th, 8th and 10th vaccination - by analysing the tumor-specificity of circulating lymphocytes pre vaccination and at the time point of the 4th, 8th, 10th vaccination and 3 months later (ELISPOT). | — |
Countries
Germany
Contacts
Public ContactRalph Oberneder
Urologische Klinik Dr. Castringius München-Planegg
Outcome results
None listed