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PRIMARY OBJECTIVES: Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs .
SECONDARY OBJECTIVES:Determine immunological response to the vaccine (induction of specific T-cell response) and assessment of tumour response
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dendritic Cells (DC) malignant melanoma | Experimental | 22 patients were included in this arm. |
|
| DC vaccine plus IL-2 | Experimental | To improve the efficacy of the DC vaccine, IL-2 was administrated at the vaccination site through direct lymph node injection. 9 patients were included in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dendritic Cells (DC) malignant melanoma | Biological | The patients were assigned to intradermal or intranodal DC vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of safety and toxicity of vaccination with patients' tumour mRNA transfected DCs | Biochemistry and hematology results, vital signs and ECOG performance status are measured at those timepoints. | Patients are coming every week during 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine immunological response to the vaccine (induction of specific T-cell response) | 6 weeks and 3 months after study start | |
| Assessment of tumour response. | CT-scan | 3 months after study start |
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Inclusion Criteria:
ANC > 1.5 x 109/L; platelets > 100 x 109/L, Hb > 9g/dL (> 5.6 mmol/L). Creatinine < 140 µmol/L (1.6 mg/dL); if borderline, the creatinine clearance > 40 mL/min, Bilirubin < 20% above the upper limit of normal, ASAT and ALAT < 2.5 the upper limit of normal. Albumin > 2.5 g/L.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steinar Aamdal, M.D PhD Prof | Oslo University Hospital - Norwegian Radium Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16710345 | Result | Kyte JA, Mu L, Aamdal S, Kvalheim G, Dueland S, Hauser M, Gullestad HP, Ryder T, Lislerud K, Hammerstad H, Gaudernack G. Phase I/II trial of melanoma therapy with dendritic cells transfected with autologous tumor-mRNA. Cancer Gene Ther. 2006 Oct;13(10):905-18. doi: 10.1038/sj.cgt.7700961. Epub 2006 May 5. | |
| 16947019 | Result |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D007376 | Interleukin-2 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| IL-2 | Procedure | IL-2 were administrated by intranodal injection |
|
| Kyte JA, Kvalheim G, Lislerud K, thor Straten P, Dueland S, Aamdal S, Gaudernack G. T cell responses in melanoma patients after vaccination with tumor-mRNA transfected dendritic cells. Cancer Immunol Immunother. 2007 May;56(5):659-75. doi: 10.1007/s00262-006-0222-y. Epub 2006 Sep 1. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |