Phase I study of a gene modified, B7/IL-2 transfected allogeneic tumor cell vaccine for the treatment of metastatic renal cell carcinoma
- Conditions
- C64Malignant neoplasm of kidney, except renal pelvis
- Registration Number
- DRKS00000249
- Lead Sponsor
- udwig-Maximilians-Universität MünchenLabor für Tumorimmunologie, LIFE-Zentrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
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
- 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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety and toxicity:<br>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 Outcome Measures
Name Time Method 1. Improvement of the clinical situation:<br>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.<br><br>2. Development of an immune response:<br>- by analysing the infiltrate at the injection site (biopsy: histology, flow cytometry) 48 hrs after the 4th, 8th and 10th vaccination<br>- 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).