The purpose of this study is to determine if treatment with the autologous cellular vaccine, Melaxin, in combination with Bacillus Calmette-Guerin (BCG) injections is effective in Stage IV malignant melanoma.

开始日期2008-04-01

申办/合作机构

Prisma Health

[+1]

100 项与 Autologous dendritoma vaccine(Oncolix) 相关的临床结果

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100 项与 Autologous dendritoma vaccine(Oncolix) 相关的转化医学

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100 项与 Autologous dendritoma vaccine(Oncolix) 相关的专利（医药）

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项与 Autologous dendritoma vaccine(Oncolix) 相关的文献（医药）

2018-04-01·Immunotherapy4区 · 医学

Tumor Lysate Particle Loaded Dendritic Cell Vaccine: Preclinical Testing of a Novel Personalized Cancer Vaccine

4区 · 医学

Article

作者: Jackson, Doreen O ; Yin, Sook ; Hale, Diane F ; Vreeland, Timothy J ; Peoples, George E ; Hardin, Mark O ; Herbert, Garth S ; Wagner, Thomas E ; Berry, John E ; Nichols, Pauline ; Clifton, Guy T ; Yu, Xianzhong ; Greene, Julia M

Aim: We developed a novel approach to efficiently deliver autologous tumor antigens to the cytoplasm of dendritic cells (DC) using yeast cell wall particles (YCWP). Materials and Methods: Loading of YCWP, leakage of protein from loaded YCWP and cytoplasmic delivery of YCWP content was assessed using fluorescent-tagged experiments. Spectrophotometric analysis compared the epitope-specific T-cell responses following antigen presentation via YCWP versus exogenous loading. The in vivo effectiveness of tumor lysate (TL) particle loaded DC (TLPLDC) vaccine was assessed using murine melanoma models. Results: In fluorescence-tagged experiments, YCWP efficiently delivered antigen to the cytoplasm of DC. TLPLDC loading was more effective than conventional exogenous loading of DC. Finally, in murine melanoma models, TLPLDC outperformed an analogous dendritoma vaccine. Conclusion: The TLPLDC vaccine is commercially scalable and holds the potential of producing personalized vaccines.

2016-04-01·Cancer Immunology, Immunotherapy2区 · 医学

A phase I/IIa clinical trial in stage IV melanoma of an autologous tumor–dendritic cell fusion (dendritoma) vaccine with low dose interleukin-2

2区 · 医学

Article

作者: Peoples, George E ; Hardin, Mark O ; Schneble, Erika J ; Flores, Madeline ; Wagner, Thomas E ; Yu, Xianzhong ; Greene, Julia M ; Hale, Diane F ; Jackson, Doreen O ; Herbert, Garth S ; Vreeland, Timothy J ; Martin, Jonathan

BACKGROUNDStage IV melanoma has high mortality, largely unaffected by traditional therapies. Immunotherapy including cytokine therapies and checkpoint inhibitors improves outcomes, but has significant toxicities. In this phase I/IIa trial, we investigated safety and efficacy of a dendritoma vaccine, an active, specific immunotherapy, in stage IV melanoma patients.METHODSAutologous tumor lysate and dendritic cells were fused creating dendritoma vaccines for each patient. Phase I patients were vaccinated every 3 months with IL-2 given for 5 days after initial inoculation. Phase IIa patients were vaccinated every 6 weeks with IL-2 given on days 1, 3 and 5 after initial inoculation. Toxicity and clinical outcomes were assessed.RESULTSTwenty-five patients were enrolled and inoculated. All dendritoma and IL-2 toxicities were CONCLUSIONSThe dendritoma vaccine has minimal toxicity profile with potential clinical benefit. There was OS advantage for NED stage IV patients, those receiving higher number of doses and increased frequency. Based on these results, we initiated a phase IIb trial utilizing improved dendritoma technology in the adjuvant setting for NED stage III/IV melanoma patients.

International Journal of Oncology2区 · 医学

Dendritoma vaccination combined with low dose interleukin-2 in metastatic melanoma patients induced immunological and clinical responses

2区 · 医学

Article

作者: Evans, Lyndon ; Burgin, Kelly E. ; Stephenson, Joseph J. ; Sticca, Robert P. ; Wagner, Thomas E. ; Wei, Yanzhang ; Holmes, Lillia M. ; Li, Jinhua ; Williamson, Jane ; Smith, Samuel J.

A pilot clinical trial using dendritomas, purified hybrids from the fusion of dendritic/tumor cells combined with a low dose of IL-2, in metastatic melanoma patients was conducted in order to determine its safety and potential immunological and clinical responses. Ten metastatic melanoma patients were enrolled into this study. Dendritoma vaccines were created by fusing dendritic cells stained with green fluorescent dye with irradiated autologous tumor cells stained with red fluorescent dye and purifying the hybrids using immediate fluorescent-activated cell sorting. Initial vaccine was given subcutaneously and followed by IL-2 in serially elevated doses from 3-9 million units/m2 for 5 days. Repeated vaccinations were administered without IL-2, at 3-month intervals for a maximum of 5 times. Immune reactions were measured by the increase of interferon-gamma (IFN-gamma) expressing T cells. Vaccine doses ranged from 250,000 to 1,000,000 dendritomas. There was no grade 2 or higher toxicity directly attributable to the vaccine. All patients experienced toxicity due to IL-2 administration (9-grade 2, 3-grade 3, 1-grade 4). Eight of nine evaluable patients demonstrated immunologic reactions by increased IFN-gamma expressing T cells. One patient developed partial response at 12 weeks after the first vaccine. Nine months later, this patient achieved a complete response. In addition, two patients had stable disease for 9 and 4 months, respectively; one patient had a mixed response. Our findings demonstrated that dendritoma vaccines with a low dose of IL-2 can be safely administered to patients with metastatic melanoma and induce immunological and clinical responses.

100 项与 Autologous dendritoma vaccine(Oncolix) 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
恶性黑色素瘤IV期	临床2期	美国	Oncolix, Inc.	2008-04-01
黑色素瘤	临床2期	美国	Oncolix, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00671554 (CTgov)	临床1/2期	恶性黑色素瘤IV期	3	Melaxin	醖獵艱積製鬱衊窪憲糧(膚淵製壓憲廠壓淵鑰襯) = 夢獵構積膚蓋衊遞觸積蓋築襯鬱選網繭築淵餘 (鬱廠築餘鏇簾壓繭簾蓋, 膚願廠願鹽憲選鏇鑰衊 ~ 繭鏇淵窪襯糧製選糧齋)	-	2014-06-04
AACR2013	N/A	前列腺癌	48	Vaccine	(繭網簾觸窪繭餘淵鏇壓) = 衊構觸壓鑰艱繭鹹醖糧顧鹽鑰積餘鏇艱鏇積蓋 (鹽獵獵網蓋壓築糧築網 )	-	2013-04-15
AACR2013	N/A	前列腺癌	48	novel autologous immunomodulated vaccine (Control group)	(繭網簾觸窪繭餘淵鏇壓) = 窪餘遞獵鹽遞醖糧願窪顧鹽鑰積餘鏇艱鏇積蓋 (鹽獵獵網蓋壓築糧築網 )	-	2013-04-15
ASCO2007	临床2期	黑色素瘤	15	Dendritoma vaccination	(構壓願醖獵餘繭範繭艱) = 醖網構顧願鹽廠構憲壓願醖築淵鑰積構憲鏇壓 (壓廠窪壓膚網範鬱觸獵 )	积极	2007-06-20