Randomized Phase III Study Of Adjuvant Immunization With The NA17.A2 And Melanoma Differentiation Peptites In HLA-A2 Patients With Primary Ocular Melanoma At High Risk Of Relapse

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye.
PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye.

开始日期2002-02-01

申办/合作机构

Eortc

100 项与 NA17-A antigen(EORTC) 相关的临床结果

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100 项与 NA17-A antigen(EORTC) 相关的转化医学

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100 项与 NA17-A antigen(EORTC) 相关的专利（医药）

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项与 NA17-A antigen(EORTC) 相关的文献（医药）

2006-12-15·Clinical Cancer Research1区 · 医学

Immunologic and Clinical Effects of Injecting Mature Peptide-Loaded Dendritic Cells by Intralymphatic and Intranodal Routes in Metastatic Melanoma Patients

1区 · 医学

Article

作者: Neidhard, Eve-Marie ; Birebent, Brigitte ; Collet, Brigitte ; Carsin, André ; Clapisson, Gilles ; Adamski, Henri ; Labarrière, Nathalie ; Chokri, Mohamed ; Quillien, Véronique ; Philip, Irène ; Vignard, Virginie ; Lefeuvre, Claudia ; Lesimple, Thierry ; Monnier, Delphine ; Toujas, Louis

AbstractPurpose: A phase I/II trial was conducted to evaluate clinical and immunologic responses after intralymphatic and intranodal injections of mature dendritic cells.Experimental Design: Fourteen patients with a metastatic melanoma received matured dendritic cells, loaded with Melan-A/MART-1 and/or NA17-A peptides and keyhole limpet hemocyanin. The cells were matured overnight with Ribomunyl, a toll-like receptor ligand, and IFN-γ, which ensured the production of high levels of interleukin-12p70. Dendritic cells were injected at monthly intervals, first into an afferent lymphatic and then twice intranodally. Immunologic responses were monitored by tetramer staining of circulating CD8+ lymphocytes and delayed-type hypersensitivity tests.Results: Dendritic cell vaccination induced delayed-type hypersensitivity reactivity toward NA17-A-pulsed, keyhole limpet hemocyanin–pulsed, and Melan-A-pulsed dendritic cells in 6 of 10, 4 of 11, and 3 of 9 patients, respectively. Four of the 12 patients analyzed by tetramer staining showed a significantly increased frequency of Melan-A-specific T cells, including one patient vaccinated only with NA17-A-pulsed dendritic cells. Furthermore, 2 of the 12 analyzed patients had a significant increase of NA17-A-specific T cells, including one immunized after an optional additional treatment course. No objective clinical response was observed. Two patients were stabilized at 4 and 10 months and three patients are still alive at 30, 39, and 48 months.Conclusions: Injections into the lymphatic system of mature peptide-loaded dendritic cells with potential TH1 polarization capacities did not result in marked clinical results, despite immunologic responses in some patients. This highlights the need to improve our understanding of dendritic cell physiology.

100 项与 NA17-A antigen(EORTC) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
眼部黑色素瘤	临床3期	比利时	Eortc	2002-02-01
眼部黑色素瘤	临床3期	丹麦	Eortc	2002-02-01
葡萄膜黑色素瘤	临床3期	比利时	Eortc	2002-02-01
葡萄膜黑色素瘤	临床3期	丹麦	Eortc	2002-02-01