The primary objective of this study is to answer the question "Is it possible to inject the Combig-DC vaccine in a renal tumour without getting unacceptable side effects"? Patients newly diagnosed with metastatic renal cell carcinoma will get Combig-DC vaccinations at two occasions in a two weeks period (day 1 and day 14). After another two weeks the kidney will be eliminated. Adverse events will be registered, as well as changes in vital signs(heart rate, blood pressure and body temperature) and lab parameters. Immunologic response will be evaluated by measuring immunologic markers in blood and tumour tissue, and measuring the size of the metastases three months after nephrectomy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Cryopreserved dendritic cell suspension of 10 million cells per ml in heat-inactivated plasma, supplemented with 10% dimethyl sulfoxide (DMSO).
Dept of Oncology, University Hospital
Uppsala, Sweden
Registration of adverse events as a measure of safety and tolerability
Time frame: 1 year 3 months (Feb 2012-May 2013)
Changes in vital signs from baseline (heart rate, blood pressure, body temperature) as a measure of safety and tolerability
Time frame: 1 year 3 months (Feb 2012 - May 2013)
Changes in lab parameters from baseline as a measure of safety and tolerability
Time frame: 1 year 3 months (Feb 2012 - May 2013)
Immunologic response in blood (immunologic panel) measured with ELISPOT.
Time for sampling: just before first injection and second injection, 2 weeks post second injection (in connection with the hospitalization for nephrectomy) and at 3 months post nephrectomy. ELISPOT assessment will be made at time of nephrectomy (after the second vaccination) at earliest.
Time frame: 1 year 3 months (Feb 2012 - May 2013)
Examination of immunohistology parameters (macrophage marker, CD3, CD4, CD8, CD56) of the renal tumor post nephrectomy.
Time frame: 1 year 3 months (Feb 2012 - May 2013)
CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy
Time frame: 1 year 3 months (Feb 2012 - March 2013)
CT evaluation to evaluate number of metastases 3 months post nephrectomy.
Time frame: 1 year 3 months (Feb 2012 - May 2013)
Changes in body weight 3 months post nephrectomy vs. baseline.
Time frame: 1 year 3 months (Feb 2012 - May 2013)
Changes in WHO-ECOG 3 months post nephrectomy vs. baseline.
Time frame: 1 year 3 months (Feb 2012 - may 2013)
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