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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002039-25 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combig-DC Cancer Vaccine | Experimental | Two vaccinations of Combig-DC (allogeneic dendritic cells) Cancer Vaccine given before nephrectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combig-DC (allogeneic dendritic cells) Cancer Vaccine | Biological | Cryopreserved dendritic cell suspension of 10 million cells per ml in heat-inactivated plasma, supplemented with 10% dimethyl sulfoxide (DMSO). |
| Measure | Description | Time Frame |
|---|---|---|
| Registration of adverse events as a measure of safety and tolerability | 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 | 1 year 3 months (Feb 2012 - May 2013) | |
| Changes in lab parameters from baseline as a measure of safety and tolerability | 1 year 3 months (Feb 2012 - May 2013) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year 3 months (Feb 2012 - May 2013) |
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Inclusion Criteria:
Be informed of the nature of the study and have provided written informed consent
At least 18 years of age.
Diagnosis of renal cell carcinoma with at least one distant metastasis, and/or one distant lymph node metastasis.
Tumor size (renal cell carcinoma; primary tumor) at least 4.0 cm in longest diameter as measured by CT. Distant metastasis at least 1 cm diameter as measured by CT or a distant lymph node metastasis at least 2,5 cm diameter as measured by CT. Clinical stage 'T1b or more; NX; M1'
Adequate hematological parameters, i.e:
B-Leukocyte count ≥ 4.5 x 109/L B-Platelet count ≥ 150 x109/L B-Haemoglobin ≥ 100 g/L
Women of Childbearing Potential (WOCBP) should use adequate contraception (oral or injectable contraceptives, hormone releasing intrauterine device) throughout the study period.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Laurell, MD, PhD | Dept of Oncology , Uppsala University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Oncology, University Hospital | Uppsala | 751 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28642820 | Derived | Laurell A, Lonnemark M, Brekkan E, Magnusson A, Tolf A, Wallgren AC, Andersson B, Adamson L, Kiessling R, Karlsson-Parra A. Intratumorally injected pro-inflammatory allogeneic dendritic cells as immune enhancers: a first-in-human study in unfavourable risk patients with metastatic renal cell carcinoma. J Immunother Cancer. 2017 Jun 20;5:52. doi: 10.1186/s40425-017-0255-0. eCollection 2017. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D019496 | Cancer Vaccines |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Examination of immunohistology parameters (macrophage marker, CD3, CD4, CD8, CD56) of the renal tumor post nephrectomy. | 1 year 3 months (Feb 2012 - May 2013) |
| CT-evaluation of the size of the metastasis(-es) 3 months post nephrectomy | 1 year 3 months (Feb 2012 - March 2013) |
| CT evaluation to evaluate number of metastases 3 months post nephrectomy. | 1 year 3 months (Feb 2012 - May 2013) |
| Changes in body weight 3 months post nephrectomy vs. baseline. | 1 year 3 months (Feb 2012 - May 2013) |
| Changes in WHO-ECOG 3 months post nephrectomy vs. baseline. | 1 year 3 months (Feb 2012 - may 2013) |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |