Phase II study of Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy for maintenance of Patients With Neovascular Maculopathy - Anti-VEGFR Vaccine Therapy in Treating Patients With Neovascular Maculopathy(Phase II)

开始日期2011-09-01

申办/合作机构-

NCT01266707 / Unknown status临床1期IIT

Phase 1 Study of HLA-A*2402 Restricted Antiangiogenic Peptide Vaccine Therapy Using Epitope Peptide Derived Feom VEGFR1 and VEGFR2 in Treating Patients With Unresectable, Recurrent, or Metastatic Hepatocellular Carcinoma

The purpose of this study is to assess toxicities of angiogenic peptide vaccine therapy in treating HLA-A*2402 restricted patients with advanced hepatocellular carcinoma.

开始日期2007-03-01

申办/合作机构

Fukushima Medical University

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项与 HLA-A*2402 Restricted Antiangiogenic Peptide Vaccine(Fukushima Medical University) 相关的文献（医药）

2014-01-01·Journal of Translational Medicine2区 · 医学

Phase I clinical study of multiple epitope peptide vaccine combined with chemoradiation therapy in esophageal cancer patients

2区 · 医学

ArticleOA

作者: Takuya Tsunoda ; Hisae Iinuma ; Koji Yoshida ; Ryoji Fukushima ; Tsuyoshi Inaba ; Noriyuki Matsutani ; Yusuke Nakamura ; Junko Tamura ; Tadashi Ikeda ; Masahiro Horikawa ; Kazuyoshi Takeda ; Etsushi Ogawa ; Kota Okinaga ; Yoshibumi Ikeda ; Taisuke Inoue

BACKGROUNDChemoradiation therapy (CRT) has been widely used for unresectable esophageal squamous cell carcinoma (ESCC) patients. However, many patients develop local recurrence after CRT. In this study, we hypothesized that the immunotherapy by peptide vaccine may be effective for the eradication of minimal residual cancer cells after CRT. This study was conducted as a phase I clinical trial of multiple-peptide vaccine therapy combined with CRT on patients with unresectable ESCC.PATIENTS AND METHODSHLA-A*2402 positive 11 unresectable chemo-naïve ESCC patients were treated by HLA-A*2402-restricted multi-peptide vaccine combined with CRT. The peptide vaccine included the 5 peptides as follows; TTK protein kinase (TTK), up-regulated lung cancer 10 (URLC10), insulin-like growth factor-II mRNA binding protein 3 (KOC1), vascular endothelial growth factor receptor 1 (VEGFR1) and 2 (VEGFR2). CRT consisted of radiotherapy (60 Gy) with concurrent cisplatin (40 mg/m²) and 5-fluorouracil (400 mg/m²). Peptide vaccines mixed with incomplete Freund's adjuvant were injected subcutaneously once a week on at least 8 occasions combined with CRT.RESULTSVaccination with CRT therapy was well-tolerated, and no severe adverse effects were observed. In the case of grade 3 toxicities, leucopenia, neutropenia, anemia and thrombocutopenia occurred in 54.5%, 27.3%, 27.3% and 9.1% of patients, respectively. Grade 1 local skin reactions in the injection sites of vaccination were observed in 81.8% of patients. The expressions of HLA class I, URLC10, TTK, KOC1, VEGFR1 and VEGFR2 antigens were observed in the tumor tissues of all patients. All patients showed peptide-specific cytotoxic T lymphocytes responses in at least one of the 5 kinds of peptide antigens during the vaccination. Six cases of complete response (CR) and 5 cases of progressive disease (PD) were observed after the 8th vaccination. The 4 CR patients who continued the peptide vaccination experienced long consistent CR for 2.0, 2.9 4.5 and 4.6 years.CONCLUSIONSA combination therapy of multi-peptide vaccine with CRT can successfully be performed with satisfactory levels of safety, and application of this combination therapy may be an effective treatment for patients with unresectable ESCC.TRIAL REGISTRATIONClinicalTrial.gov, number NCT00632333.

2010-12-01·Journal of Translational Medicine2区 · 医学

Phase I clinical trial of the vaccination for the patients with metastatic melanoma using gp100-derived epitope peptide restricted to HLA-A*2402

2区 · 医学

ArticleOA

作者: Hideaki Tahara ; Naoki Oyaizu ; Marimo Sato-Matsushita ; Toshiyuki Baba ; Akira Kanamoto ; Yutaka Kawakami ; Akihiko Itoh ; Yusuke Inoue

AbstractBackgroundThe tumor associated antigen (TAA) gp100 was one of the first identified and has been used in clinical trials to treat melanoma patients. However, the gp100 epitope peptide restricted to HLA-A*2402 has not been extensively examined clinically due to the ethnic variations. Since it is the most common HLA Class I allele in the Japanese population, we performed a phase I clinical trial of cancer vaccination using the HLA-A*2402 gp100 peptide to treat patients with metastatic melanoma.MethodsThe phase I clinical protocol to test a HLA-A*2402 gp100 peptide-based cancer vaccine was designed to evaluate safety as the primary endpoint and was approved by The University of Tokyo Institutional Review Board. Information related to the immunologic and antitumor responses were also collected as secondary endpoints. Patients that were HLA-A*2402 positive with stage IV melanoma were enrolled according to the criteria set by the protocol and immunized with a vaccine consisting of epitope peptide (VYFFLPDHL, gp100-in4) emulsified with incomplete Freund's adjuvant (IFA) for the total of 4 times with two week intervals. Prior to each vaccination, peripheral blood mononuclear cells (PBMCs) were separated from the blood and stored at -80°C. The stored PBMCs were thawed and examined for the frequency of the peptide specific T lymphocytes by IFN-γ- ELISPOT and MHC-Dextramer assays.ResultsNo related adverse events greater than grade I were observed in the six patients enrolled in this study. No clinical responses were observed in the enrolled patients although vitiligo was observed after the vaccination in two patients. Promotion of peptide specific immune responses was observed in four patients with ELISPOT assay. Furthermore, a significant increase of CD8+gp100-in4+CTLs was observed in all patients using the MHC-Dextramer assay. Cytotoxic T lymphocytes (CTLs) clones specific to gp100-in4 were successfully established from the PBMC of some patients and these CTL clones were capable of lysing the melanoma cell line, 888 mel, which endogenously expresses HLA-restricted gp100-in4.ConclusionOur results suggest this HLA-restricted gp100-in4 peptide vaccination protocol was well-tolerated and can induce antigen-specific T-cell responses in multiple patients. Although no objective anti-tumor effects were observed, the effectiveness of this approach can be enhanced with the appropriate modifications.

2009-06-05·Oncology Reports3区 · 医学

Characterization of cytomegalovirus pp65-HLA-A24 peptide-specific CTL lines from metastatic melanoma patients

3区 · 医学

Article

作者: Takikawa, Masako ; Yamamoto, Akifumi ; Yamazaki, Naoya ; Komiyama, Masaru ; Akiyama, Yasuto ; Kiyohara, Yoshio ; Ohshita, Chie ; Tai, Sachiko

Because of advances in immunological technology for detecting a very small number of blood CTL cells, clinicians have been able to monitor cellular immunity against CMV and evaluate the status of CMV infections in highly advanced cancer patients or transplant recipients. Our previous study using healthy volunteer PBLs revealed a significant increase in CMV HLA-A24 tetramer+ CTLs after stimulation in vitro with autologous DCs. However, the efficiency of CMV A24 peptide-specific CTL expansion in highly advanced cancer patients has yet to be studied in detail. In the present study, we tried to characterize and expand HLA-A*2402 CMVpp65 peptide (QYDPVAALF)-specific tetramer+ CTLs from HLA-A*2402+ metastatic melanoma patients, and eventually demonstrated that expansion efficiency was closely related to both post-stimulation CMV tetramer frequency and anti-CMV IgG titer. This is a novel finding regarding in vitro CMVpp65-A24 peptide-specific CTL expansion based on metastatic cancer patient-derived PBLs. Interestingly, the current results using metastatic melanoma PBLs showed a much higher frequency of CMVpp65-A24 tetramer+ CTLs and expansion efficiency than in healthy volunteers. Finally, we were successful in cloning CMVpp65 HLA-A24 peptide-specific TCR cDNAs from in vitro expanded CTL lines derived from melanoma patients. Additionally, CMVpp65 HLA-A24 peptide-specific TCR cDNA was transduced into naive T cells from patients and functionally reconstructed. The results showed that cloned CMV-specific TCR genes were efficient in reconstituting specific anti-CMV activity and might be good tools for adoptive immunotherapy against CMV infections.

100 项与 HLA-A*2402 Restricted Antiangiogenic Peptide Vaccine(Fukushima Medical University) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
转移性肝细胞癌	临床1期	日本	Fukushima Medical University	2007-03-01

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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


JVCG (WCLC2016)	N/A	非小细胞肺癌	192	Docetaxel with Antiangiogenic Agent	糧襯鹹構齋製製簾齋鬱(鑰觸餘築窪醖繭鏇積醖): HR = 0.802 (95% CI, 0.537 ~ 1.199), P-Value = 0.5956 更多	-	2016-12-06
				Docetaxel without Antiangiogenic Agent