Recombinant fowlpox-TRICOM vaccine(NCI)(Recombinant fowlpox-TRICOM vaccine(NCI))

概要

基本信息

药物类型

预防性疫苗

别名-

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

肿瘤皮肤和肌肉骨骼疾病泌尿生殖系统疾病

在研适应症-

非在研适应症

膀胱鳞状细胞癌去势抵抗性前列腺癌IV期恶性黑色素瘤+ [6]

原研机构

National Cancer Institute

在研机构-

非在研机构

National Cancer Institute

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

6

项与 Recombinant fowlpox-TRICOM vaccine(NCI) 相关的临床试验

NCT02153918

/ Completed临床2期IIT

A Phase II Study of Neoadjuvant rFowlpox-PSA (L155)-TRICOM (Prostvac-F/TRICOM) in Combination With rVaccinia-PSA (L155)-TRICOM (Prostvac-V/TRICOM) in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy

Background:
- Some men with prostate cancer have their prostate glands removed. The cancer can still come back. Researchers want to know if receiving a vaccine before prostate removal surgery can lead to less recurrence.
Objective:
- To see if a vaccine and booster shots given to men with prostate cancer before surgery changes the immune cells in the prostate gland.
Eligibility:
- Men age 18 and older who have prostate cancer that has not spread, and who want to have their prostate glands removed as treatment.
Design:
Participants will be screened by their regular cancer care. They may have a small piece of prostate removed.
Participants must practice effective birth control before and during the study treatment and for 1 month after the last vaccine booster.
Participants will have a medical history, physical exam, and blood and liver tests. They will be asked about how they perform daily activities.
Participants will have a magnetic resonance imaging (MRI) scan of the prostate. The scanner is a metal cylinder in a strong magnetic field. Participants will lie on a table that slides in and out of the scanner.
Participants will be injected with the vaccine, most likely in the leg. They will be injected with the vaccine booster 3 times over several weeks.
At each booster visit, participants will have a medical history, physical exam, and blood and liver tests.
Participants will have another MRI. Then they will have surgery to remove their prostate.
Participants will have 2 follow-up visits during the year after surgery. They will have a medical history, physical exam, and blood test.

开始日期2014-05-31

申办/合作机构

National Cancer Institute

NCT00450619

/ Completed临床2期IIT

A Randomized Phase 2.5 Study of (153)Sm-EDTMP (Quadramet) With or Without a PSA/TRICOM Vaccine in Men With Androgen-Insensitive Metastatic Prostate Cancer

Background:
No treatment is known to improve survival for prostate cancer patients who have not been helped by previous treatments with hormones and chemotherapy.
An experimental vaccine called prostate specific antigen (PSA)/TRICOM contains genes for a protein produced by prostate cancer cells called prostate-specific antigen (PSA). The vaccine can trigger the immune system to make cells that may be able to recognize and attack the cancer cells that make PSA.
Granulocyte macrophage colony stimulating factor (GM-CSF) is an approved drug that is usually given to increase a patient's white blood cell count or to stimulate the immune system.
1Samarium-153-ethylene diamine tetramethylene phosphonate (53Sm-EDTMP) is a radioactive drug that has been approved for many years to treat advanced prostate cancer. It is given through a vein and can be targeted directly to tumors in the bone where it can relieve pain caused by bone lesions. Radiation also increases the level of certain proteins inside the tumor, making it easier for the immune system to find and kill the tumor cells.
When laboratory mice were given just vaccine, just radiation, or a combination of both, the combination was most effective in treating tumors.
Objectives:
-To determine if combined treatment with PSA/TRICOM vaccine and 153Sm-EDTMP radiation can delay progression of prostate cancer better than radiation alone.
Eligibility:
-Patients who have advanced prostate cancer that has worsened despite treatments with hormones, have two or more bone lesions related to their prostate cancer, and have had prior treatment with docetaxel chemotherapy.
Design:
Patients are randomly assigned to receive radiation alone (Arm A) or radiation with vaccine and sargramostim (Arm B).
Arm A receives 153Sm-EDTMP radiation starting on study day 8 and repeated every 12 weeks.
Arm B receives a priming vaccine on study day 1 and radiation on day 8. Radiation therapy is repeated every 12 weeks. Boosting vaccines are given on days 15 and 29 and then monthly. GM-CSF is given with each vaccination (on the day of the vaccination and for the next 3 days) to enhance the immune response. Vaccinations and GM-CSF are given as injections under the skin, usually in the thigh. Radiation therapy is given through a vein.
Patients are monitored regularly with physical examinations, blood and urine tests, and scans to evaluate safety and treatment response.
Patients who are human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2)-positive undergo apheresis, a procedure similar to donating blood, for obtaining immune cells called lymphocytes to measure the immune response to the vaccine.

开始日期2007-02-01

申办/合作机构

National Cancer Institute

NCT00087373

/ Terminated临床2期IIT

Phase II Study of Intratumoral Injection of rF-TRICOMTM in Patients With Metastatic Melanoma Who Have Detectable Tumor Associated T Cells

Vaccines may make the body build an immune response to kill tumor cells. Injecting a vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

开始日期2004-06-01

申办/合作机构

National Cancer Institute

100 项与 Recombinant fowlpox-TRICOM vaccine(NCI) 相关的临床结果

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100 项与 Recombinant fowlpox-TRICOM vaccine(NCI) 相关的转化医学

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100 项与 Recombinant fowlpox-TRICOM vaccine(NCI) 相关的专利（医药）

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8

项与 Recombinant fowlpox-TRICOM vaccine(NCI) 相关的文献（医药）

2014-05-01·Human Gene Therapy2区 · 医学

Results of a Randomized Phase I Gene Therapy Clinical Trial of Nononcolytic Fowlpox Viruses Encoding T Cell Costimulatory Molecules

2区 · 医学

Article

作者: Kim-Schulze, Seunghee ; Jagoda, Michael C. ; Kaufman, Howard L. ; Broucek, Joseph R. ; Kim, Dae Won ; Zloza, Andrew ; DeRaffele, Gail

Oncolytic viruses have shown promise as gene delivery vehicles in the treatment of cancer; however, their efficacy may be inhibited by the induction of anti-viral antibody titers. Fowlpox virus is a nonreplicating and nononcolytic vector that has been associated with lesser humoral but greater cell-mediated immunity in animal tumor models. To test whether fowlpox virus gene therapy is safe and can elicit immune responses in patients with cancer, we conducted a randomized phase I clinical trial of two recombinant fowlpox viruses encoding human B7.1 or a triad of costimulatory molecules (B7.1, ICAM-1, and LFA-3; TRICOM). Twelve patients (10 with melanoma and 2 with colon adenocarcinoma) enrolled in the trial and were randomized to rF-B7.1 or rF-TRICOM administered in a dose escalation manner (~3.7×10(7) or ~3.7×10(8) plaque-forming units) by intralesional injection every 4 weeks. The therapy was well tolerated, with only four patients experiencing grade 1 fever or injection site pain, and there were no serious adverse events. All patients developed anti-viral antibody titers after vector delivery, and posttreatment anti-carcinoembryonic antigen antibody titers were detected in the two patients with colon cancer. All patients developed CD8(+) T cell responses against fowlpox virus, but few responses against defined tumor-associated antigens were observed. This is the first clinical trial of direct (intratumoral) gene therapy with a nononcolytic fowlpox virus. Treatment was well tolerated in patients with metastatic cancer; all subjects exhibited anti-viral antibody responses, but limited tumor-specific T cell responses were detected. Nononcolytic fowlpox viruses are safe and induce limited T cell responses in patients with cancer. Further development may include prime-boost strategies using oncolytic viruses for initial priming.

2007-03-15·Clinical Cancer Research1区 · 医学

Combination Therapy of an Orthotopic Renal Cell Carcinoma Model Using Intratumoral Vector-Mediated Costimulation and Systemic Interleukin-2

1区 · 医学

Article

作者: Hodge, James W. ; Wiltrout, Robert ; Kudo-Saito, Chie ; Gruys, M. Eilene ; Wansley, Elizabeth K. ; Schlom, Jeffrey

AbstractPurpose: Interleukin (IL)-2 therapy is currently used for therapy of renal cell carcinoma (RCC). However, it is only effective in approximately 10% to 15% of patients, showing a need for additional therapies. We have previously described a replication-defective fowlpox vector encoding three costimulatory molecules (B7-1, ICAM-1, and LFA-3), designated rF-TRICOM. Here, we show that intratumoral administration of rF-TRICOM in an orthotopic RCC model effectively enhances tumor immunogenicity and reduces tumor burden in mice and the combination of rF-TRICOM and IL-2 is more effective than either therapy alone.Experimental Design: RCC cells were implanted under the capsule of the kidney, and mice were given rF-TRICOM intratumorally 14 days later. We compared the effect of rF-TRICOM, rF-granulocyte macrophage colony-stimulating factor (GM-CSF), and two doses of IL-2 and combinations of the above on antitumor efficacy and survival. Host CD4+ and CD8+ T-cell responses were also evaluated.Results: The results show that (a) systemic IL-2 therapy was moderately effective in the reduction of tumor burden in an orthotopic RCC model; (b) a single intratumoral injection of rF-TRICOM and rF-GM-CSF significantly reduced tumor burden; (c) the addition of systemic IL-2 to intratumoral rF-TRICOM/rF-GM-CSF administration resulted in further reduction of tumor burden, decrease in the incidence of metastasis, and extended survival in tumor-bearing mice above that seen with either treatment alone; and (d) CD8+ T cells played a critical role in the antitumor effect seen with rF-TRICOM/rF-GM-CSF + IL-2 therapy. Finally, the addition of systemic recombinant IL-15 or intratumoral vector-delivered IL-15 to intratumoral rF-TRICOM/rF-GM-CSF administration resulted in substantially more tumor-free mice than either therapy alone.Conclusions: These studies show that intratumoral administration of rF-TRICOM admixed with rF-GM-CSF is effective at reducing tumor burden in mice and the addition of IL-2 further contributes to this effect. These studies thus form the rationale for combination immunotherapy clinical trials in patients with RCC.

2005-08-01·Clinical Cancer Research1区 · 医学

Induction of Higher-Avidity Human CTLs by Vector-Mediated Enhanced Costimulation of Antigen-Presenting Cells

1区 · 医学

Article

作者: Schlom, Jeffrey ; Yang, Sixun ; Tsang, Kwong-Yok

AbstractThe efficacy of antigen-specific CD8+ CTLs depends not only on the quantity of CTLs generated but also perhaps, more importantly, on the avidity of the CTLs. To date, however, no strategy has been shown to preferentially induce higher-avidity human CTLs. In the present study, antigen-presenting cells (APC) generated from human peripheral blood mononuclear cells were infected with a recombinant avipox vector (rF-) containing the transgenes for a triad of costimulatory molecules (human B7.1, intercellular adhesion molecule-1, and LFA-3, designated as rF-TRICOM) and then used to elicit peptide-specific CTLs from autologous T cells. Compared with peptide-pulsed noninfected APCs or peptide-pulsed APCs infected with wild-type vector, peptide-pulsed APCs infected with rF-TRICOM induced not only more CTLs but also higher-avidity CTLs; this was shown by tetramer staining, tetramer dissociation, IFN-γ production, and cytolytic assays. Peptide-pulsed rF-TRICOM-infected dendritic cells were also shown to induce CTLs with a >10-fold higher avidity than CTLs induced using CD40L-matured dendritic cells; the use of peptide-pulsed CD40L-matured dendritic cells infected with rF-TRICOM as APCs induced CTLs of even greater avidity. To our knowledge, these studies are the first to show a methodology to induce higher-avidity human CTLs and have implications for the development of more efficient vaccines for a range of human cancers.

100 项与 Recombinant fowlpox-TRICOM vaccine(NCI) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
去势抵抗性前列腺癌	临床2期	美国	National Cancer Institute	2007-02-01
IV期恶性黑色素瘤	临床2期	美国	National Cancer Institute	2004-06-01
复发性黑色素瘤	临床2期	美国	National Cancer Institute	2004-06-01
转移性黑色素瘤	临床2期	美国	National Cancer Institute	2004-06-01
膀胱鳞状细胞癌	临床2期	美国	National Cancer Institute	2003-10-01
复发性膀胱癌	临床2期	美国	National Cancer Institute	2003-10-01
膀胱尿路上皮癌	临床2期	美国	National Cancer Institute	2003-10-01
转移性实体瘤	临床2期	美国	National Cancer Institute	2001-12-01
肿瘤转移	临床2期	美国	National Cancer Institute	2001-12-01

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临床结果

适应症

分期

评价

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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


NCT02153918 (CTgov)	临床2期	去势抵抗性前列腺癌	27	PROSTVAC-F/TRICOM	繭糧蓋壓襯憲艱夢獵鏇(獵窪積餘艱糧繭選鬱簾) = 鬱繭窪製顧鑰繭鑰獵製壓網鬱齋製衊鹹積膚網 (願網憲糧願觸獵餘齋齋, 廠醖鏇網齋鬱鹽顧繭憲 ~ 鹹鏇築鏇淵網獵醖鑰襯) 更多	-	2018-10-12
NCT00450619 (CTgov)	临床2期	去势抵抗性前列腺癌	44	Samarium Sm 153 lexidronam pentasodium+Recombinant fowlpox-TRICOM vaccine+Recombinant vaccinia-TRICOM vaccine+Sargramostim	鹹觸糧網願餘憲廠獵構(網鏇選衊蓋簾膚齋蓋獵) = 網構構遞夢憲鬱觸願餘積構築憲鹹膚鹽糧壓餘 (範鑰願鹹願製遞獵顧窪, 鏇簾窪艱糧鏇壓選憲觸 ~ 網積衊鏇廠繭遞艱鬱艱) 更多	-	2013-07-01
ASCO2004	临床1期	前列腺癌	15	recombinant Fowlpox-PSA (L155)-TRICOM (rF) (rF alone)	夢選顧淵顧憲簾鏇襯簾(選製壓觸糧遞鹹壓鏇艱) = 齋範糧願艱選積選鬱醖淵鏇鬱積艱齋製顧夢淵 (夢網夢鏇憲壓鑰選齋壓 ) 更多	-	2004-07-15
ASCO2004	临床1期	前列腺癌	15	recombinant Fowlpox-PSA (L155)-TRICOM (rF) (rV followed by rF)	夢選顧淵顧憲簾鏇襯簾(選製壓觸糧遞鹹壓鏇艱) = 憲鬱繭齋鹽積鑰觸糧構淵鏇鬱積艱齋製顧夢淵 (夢網夢鏇憲壓鑰選齋壓 ) 更多	-	2004-07-15