[最全盘点]脑胶质瘤近期临床试验招募信息汇总
点击上面的“神外前沿”可以订阅
本文由细胞培养俱乐部（微信订阅号cell-culture-club）授权《神外前沿》转载，由阿朱汇编整理，在此表示感谢。
神外前沿讯，脑胶质瘤是由于大脑和脊髓胶质细胞癌变所产生的、最常见的原发性颅脑肿瘤。脑胶质瘤的年发病率为3-6人/10万人，是原发性脑瘤中发病率最高的肿瘤。统计资料显示，脑胶质瘤的患者男性多过女性，比例大约为2-3比1。由于脑胶质瘤细胞的生物多样性，生长无明显边界，难以完全切除，对放疗、化疗不甚敏感，非常容易复发，因此，脑胶质瘤至今仍是全身肿瘤中预后最差的肿瘤之一。
今天给大家盘点的胶质瘤临床最新招募，主要分为两类，一类是新诊断的，另一类是复发进展的。希望研究对研究脑胶质瘤的科研工作者提供参考。
NEW TRIALS (ADDED HERE IN THE LAST MONTH)
Added July 13, 2016
Pilot Study of Autologous T Cells Redirected to EGFRVIII-With a Chimeric Antigen Receptor in Patients With EGFRVIII+ Glioblastoma.
自体T细胞改造的针对EGFRVIII的CAR-T细胞在EGFRVIII阳性的脑胶质瘤患者中的临床研究。
Recruiting in San Francisco CA. Estimated primary completion date: July 2017.
NCT02209376
NEWLY DIAGNOSED
VACCINES AND CELL THERAPIES – NEWLY DIAGNOSED
疫苗和细胞治疗-新诊断
Randomized, double-blinded
随机双盲试验
Evaluation of Overcoming Limited Migration and Enhancing Cytomegalovirus-specific Dendritic Cell Vaccines With Adjuvant Tetanus Pre-conditioning in Patients With Newly-diagnosed Glioblastoma.
在新诊断胶质母细胞瘤患者中克服有限迁移和增强巨细胞病毒-特异性树突状细胞疫苗与辅助性破伤风联合预处理的评价。
Duke University. Estimated primary completion date: March 2019. Randomized phase 2 trial. In addition to receiving CMV-specific dendritic cell vaccinations patients will be randomized to receive pre-conditioning with either tetanus/diptheria toxoid or autologous unpulsed dendritic cells in saline. A third, unblinded group will undergo basiliximab infusions and tetanus/diptheria preconditioning in addition to the CMV-specific dendritic cell vaccine.
NCT02366728
A Phase I/II Clinical Trial of Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients.
巨细胞病毒（CMV）自体特异性细胞毒性T细胞对胶质母细胞瘤（GBM）患者的I / II期临床试验。
MD Anderson – Houston TX. Estimated primary completion date: June 2020.
For newly diagnosed GBM post-radiotherapy and temozolomide, and for recurrent GBM.
NCT02661282
Placebo-controlled
安慰剂对照
A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy.
一个CT-107与TMZ结合的在新诊断的手术切除、放化疗后联合TMZ的胶质母细胞瘤3期随机双盲、对照研究。
Recruiting in California (3 locations), Connecticut (2 locations), Atlanta GA, Kentucky (2 locations), Minneapolis MN, New Jersey (2 locations), New York (4 locations), Ohio (2 locations), Oklahoma City OK, Pennsylvania (2 locations), Portland OR, Charleston SC, Knoxville TN, Texas (3 locations), Charlottesville VA, Seattle WA, Milwaukee WI. Estimated primary completion date: December 2019.
NCT02546102
A Pilot Study to Assess the Safety, Feasibility, and Preliminary Efficacy of a Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma.
一个以新表位为基础的个性化疫苗方法治疗新诊断的胶质母细胞瘤初步研究，以评估安全性和可行性。
St. Louis MO. Study start date: October 2015. Estimated primary completion date: May 2017.
NCT02510950
A Phase I Study of a Personalized NeoAntigen Cancer Vaccine With Radiotherapy Among MGMT Unmethylated, Newly Diagnosed Glioblastoma Patients.
用个性化新生抗原癌症疫苗联合放射治疗，在MGMT未甲基化的新诊断的胶质母细胞瘤患者中的I期研究。
Boston MA (Dana Farber Cancer Institute). Estimated primary completion date: January 2018.
NCT02287428
A Phase II Study of the Safety and Efficacy of SVN53-67/M57-KLH (SurVaxM) in Survivin-Positive Newly Diagnosed Glioblastoma.
一个在Survivin阳性新诊断的胶质母细胞瘤患者中使用svn53-67 / m57-klh（survaxm）抗原肽的II期研究，以评估安全性和有效性。
Buffalo NY, Cleveland OH. Estimated primary completion date: April 2017.
NCT02455557
Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Newly Diagnosed Glioblastoma.
在新诊断的胶质母细胞瘤中进行的异体肿瘤裂解物负载的自体树突状细胞疫苗的初步临床试验。
Mayo Clinic, Rochester MN, USA. Estimated primary completion date: November 2016.
NCT01957956
Phase I Trial of Vaccination With Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line for Patients With Newly Diagnosed or Recurrent Glioblastoma.
用来自于同种异基因胶质瘤肿瘤干细胞裂解液负载的自体树突状细胞疫苗治疗初诊或复发性胶质母细胞瘤的I期临床试验。
This trial is recruiting newly diagnosed or recurrent glioblastoma patients at Cedars-Sinai Medical Center in Los Angeles. Newly diagnosed patients will receive the vaccine in conjunction with standard radiochemotherapy. This vaccine differs from other autologous (from the same patient) dendritic cell vaccines in that the lysate is not derived from the patient’s tumour, but from an allogeneic glioblastoma stem cell line. The trial started in December 2013. The principal investigator is Jethro Hu. Estimated primary completion date: October 2018.Allogeneic tumour lysate.
NCT02010606
A Phase I Trial of Actively Personalized Peptide Vaccinations Plus Poly-ICLC in Patients With Newly Diagnosed Glioblastoma Concurrent to First Line Temozolomide Maintenance Therapy (GAPVAC).
在新诊断的胶质母细胞瘤患者中使用携带聚ICLC（gapvac）的个性化肽疫苗联合一线化疗药替莫唑胺维持治疗的I期临床试验。
Recruiting in Heidelberg and Tübingen, Germany; Barcelona, Spain; Leiden, Netherlands; Geneva, Switzerland. Estimated primary completion date: July 2018.
NCT02149225
Adjuvant Dendritic-Cell Immunotherapy Plus Temozolomide Following Surgery and Chemoradiation in Patients With Newly Diagnosed Glioblastoma (ADDIT-GLIO).
手术和化疗后的新诊断胶质母细胞瘤辅佐替莫唑胺与树突状细胞疫苗的治疗。
Antwerp, Belgium. Estimated primary completion date: December 2017.
NCT02649582
An Open Label, Randomised, Phase II Study to Investigate the Efficacy and Safety of ALECSAT Treatment as an add-on Therapy to Radiotherapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma.
在新诊断为胶质母细胞瘤患者中进行的一项开放与随机的II期研究，用以评估ALECSAT治疗联合放疗、替莫唑胺治疗的安全性和有效性。
Recruiting in Göteborg, Sweden. Estimated primary completion date: January 2020. ALECSAT is an acronym for Autologous Lymphoid Effector Cells Specific Against Tumor cells.
NCT02799238
IMMUNE CHECKPOINT INHIBITORS
免疫检验点抑制剂
A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT Glioblastoma (CheckMate 498).
在非MGMT甲基化的新诊断的成人胶质母细胞瘤患者中联放疗，使用nivolumab（PD-1）抗体治疗与替莫唑胺的对比的一个随机开放的III期研究 。
Locations in the USA, Australia, Austria, Belgium, Canada, Germany, Netherlands, Poland, Spain, Switzerland, United Kingdom. Estimated primary completion date: March 2019.
NCT02617589
Phase I/II Trial of Radiation Therapy Plus Temozolomide With MK-3475 (Pembrolizumab) in Patients With Newly Diagnosed Glioblastoma.
在新诊断为胶质母细胞瘤患者中，使用放疗联合替莫唑胺与MK-3475 (Pembrolizumab) 的I/II期临床研究。
Chicago IL. Study start date: September 2015. Estimated primary completion date: March 2018.
NCT02530502
Phase 2 Study to Evaluate the Clinical Efficacy and Safety of MEDI4736 (anti–PD-L1 antibody) in Patients With Glioblastoma.
在胶质母细胞瘤患者中使用MEDI4736 (anti–PD-L1 抗体)的II期临床研究，评估安全和有效性。
Los Angeles CA, San Francisco CA, Baltimore MD, Boston MA, St. Louis MO, New York NY, Melbourne Australia. Estimated primary completion date: April 2017.
NCT02336165
Phase I Study of Temozolomide in Combination With Ipilimumab and/or Nivolumab in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma.
在新诊断的胶质母细胞瘤患者中，Ipilimumab单独或联合替莫唑胺、Nivolumab单独或联合替莫唑胺的I期临床研究。
San Francisco CA, Atlanta GA, Bethesda MD, Boston MA, New York NY, Cleveland OH, Houston TX. Estimated primary completion date: May 2016. Recruitment suspended as of May 2016.
NCT02311920
SUICIDE GENE AND IMMUNE-MEDIATED GENE THERAPY HYBRID
自杀基因和免疫基因的混合治疗
Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma (Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L gene therapy). Phase I.
结合细胞毒性和免疫刺激治疗脑胶质瘤的I期临床研究。（剂量递增的 Ad-hCMV-TK and Ad-hCMV-Flt3L腺病毒基因治疗）
Ann Arbor, USA. Estimated primary completion date: December 2018.
For newly diagnosed patients who haven’t yet had surgery. This trial is focused on GBM. I was told by the trial contact person that if the patient has a pre-operative biopsy and results come back as anaplastic astrocytoma, the patient would most likely be excluded. On the other hand, if the intraoperative diagnosis of anaplastic astrocytoma is made, the patient would receive the shots regardless. If intraoperative diagnosis is low grade glioma, the patient will not receive the shots. This therapy was highly effective in a syngeneic rat glioma model. This trial is testing a dual gene therapy, using adenoviral vectors to deliver two therapeutic genes to the tumour cells. The adenoviral vectors are infused into the peritumoral area at the time of surgery. One of the therapeutic genes is herpes simplex virus thymidine kinase (HSV1-TK). This is a viral enzyme which converts an inactive prodrug (in this case valacyclovir, administered 1-3 days after adenoviral vector delivery) into a cytotoxic drug which inhibits DNA replication. The second gene, Flt3L, causes maturation and proliferation of dendritic cells and natural killer cells. It is thought that the HSV1-TK/valacyclovir mediated death of tumour cells will expose tumour antigens, activating a subsequent antitumour immune response which will be aided by the Flt3L gene. Standard radiation and chemotherapy will follow the experimental gene therapy.
NCT01811992
FLUORESCENCE-GUIDED RESECTION
术中荧光引导技术
Fluorescence-Guided Detection of Malignant Gliomas: A Dose Ranging Study Using 5-Aminolevulinic Acid (ALA) Induced Protoporphyrin (PpIX) in a Multicenter Phase II Clinical Trial.
荧光引导技术引导的恶性脑胶质瘤的检测：一定剂量范围内使用5-氨基乙酰丙酸（ALA）诱导原卟啉（PpIX）的多中心II期临床研究。
Cleveland, Ohio, USA. Estimated primary completion date: November 2016.
NCT00752323
Trials for High Grade Glioma.
高级恶性脑胶质瘤的试验
RECURRENT AND PROGRESSIVE
复发和进展的
VACCINES AND CELL THERAPIES – RECURRENT
疫苗和细胞治疗-复发性
A Phase I/II Clinical Trial of Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients.
使用巨细胞病毒（CMV）自体特异性细胞毒性T细胞治疗胶质母细胞瘤（GBM）患者的I / II期临床试验。
MD Anderson – Houston TX. Estimated primary completion date: June 2020.
For newly diagnosed GBM post-radiotherapy and temozolomide, and for recurrent GBM.
NCT02661282
Phase I Trial of Vaccination With Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line for Patients With Newly Diagnosed or Recurrent Glioblastoma.
用来自于异基因干细胞系的裂解液负载自体树突状细胞的疫苗治疗初诊或复发性胶质母细胞瘤的I期临床试验。
This trial is recruiting newly diagnosed or recurrent glioblastoma patients at Cedars-Sinai Medical Center in Los Angeles. Newly diagnosed patients will receive the vaccine in conjunction with standard radiochemotherapy. This vaccine differs from other autologous (from the same patient) dendritic cell vaccines in that the lysate is not derived from the patient’s tumour, but from an allogeneic glioblastoma stem cell line. The trial started in December 2013. The principal investigator is Jethro Hu. Estimated primary completion date: October 2018.Prior and/or continued bevacizumab therapy is allowed
NCT02010606
Randomized, open-label
随机和开放的标记
Heat Shock Protein-Peptide Complex-96 (HSPPC-96) Vaccine Given With Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme. Randomized Phase II.
热休克蛋白肽complex-96（HSPPC-96）疫苗联合贝伐单抗或贝伐单抗单独使用，治疗手术切除后复发性多形性胶质母细胞瘤的随机II期临床试验。
The Alliance of Clinical Trials in Oncology, National Cancer Institute, and Agenus, Inc. (maker of the Prophage vaccine) are conducting this randomized phase II trial, with 74 participating study locations in the USA and an estimated enrollment of 222 patients. The Prophage vaccine used in this trial, heat-shock protein peptide complex-96 (HSPPC-96) is created from the patient’s tumor, resulting in a personalized vaccine which activates an immune response to the tumor antigens bound to HSP-96. To be eligible for this trial, patients must therefore undergo surgical tumor resection to acquire sufficient tumor tissue to create the vaccine. Patients are randomized into one of three arms: experimental arm 1 receives concomitant bevacizumab and HSPPC-96 vaccine; experimental arm 2 receives the vaccine alone followed by bevacizumab alone at the time of disease progression; the comparator group (arm 3) receives intravenous bevacizumab alone, without vaccine. A phase II trial of HSPPC-96 (Prophage) vaccine alone in recurrent glioblastoma was recently published in Neuro-Oncology. Estimated primary completion date: April 2016. No prior treatment with any anti-angiogenic agent targeting the VEGF pathway including but not limited to bevacizumab
NCT01814813
A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients With Recurrent Glioblastoma Multiforme.
用sl-701，一个皮下注射多价胶质瘤相关抗原的疫苗治疗成人复发性多形性胶质母细胞瘤的1/II期临床。
Following the administration of SL-701 and poly-ICLC, bevacizumab will be administered IV at a dose of 10 mg/kg. Recruiting in Phoenix AZ, Tucson AZ, Los Angeles CA, Washington DC, Chicago IL, Boston MA, Detroit MI, New York NY, Cleveland OH, Pittsburgh PA, Providence RI, Charlottesville VA, Milwaukee WI. Prior cancer chemotherapy, bevacizumab (or other vascular endothelial growth factor-directed agent), or an investigational agent for recurrent/progressive GBM or prior bevacizumab as part of initial therapy excluded. Estimated primary completion date: July 2017.
NCT02078648
Placebo-controlled
安慰剂对照
A Randomized, Double-blinded, Placebo-controlled Study of (ERC1671/GM-CSF/Cyclophosphamide) + Bevacizumab vs. (Placebo Injection/Placebo Pill) + Bevacizumab in the Treatment of Recurrent, Bevacizumab naïve Glioblastoma Multiforme Patients.
一项使用（erc1671 / GM-CSF /环磷酰胺）+贝伐单抗vs（安慰剂注射安慰剂）+贝伐单抗Bevacizumab治疗复发性初始的多形性胶质母细胞瘤患者的随机、双盲、安慰剂对照研究。
University of California, Irvine. Estimated primary completion date: March 2016. For recurrent/progressive, bevacizumab-naïve glioblastoma multiforme and gliosarcoma.Recruitment status unknown.
NCT01903330
Pilot Study of Autologous T Cells Redirected to EGFRVIII-With a Chimeric Antigen Receptor in Patients With EGFRVIII+ Glioblastoma.
自体T细胞改造的针对EGFRVIII的CAR-T细胞在EGFRVIII阳性的脑胶质瘤患者中的临床研究。
Recruiting in San Francisco CA. Estimated primary completion date: July 2017.
NCT02209376
ONCOLYTIC VIROTHERAPY TRIALS – RECURRENT
溶瘤病毒治疗试验–复发性
A Phase II, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) With Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma (CAPTIVE/KEYNOTE-192)
条件复制型腺病毒（dnx-2401）与pembrolizumab（Keytruda®）联用治疗复发性胶质母细胞瘤或胶质肉瘤的II期，多中心，开放性研究。
Recruiting in Salt Lake City UT. Not yet recruiting in Little Rock AR, New York NY. Estimated primary completion date: December 2019.
NCT02798406
A Phase 1b, Randomized, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) and Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma (TARGET-I).
条件复制型腺病毒（dnx-2401）与伽马干扰素（IFN-γ）联用治疗复发性胶质母细胞瘤或胶质肉瘤的II期，多中心，开放性研究。
Tampa FL, Houston TX. Estimated primary completion date: August 2017. First or second recurrence only.
NCT02197169
Poliovirus Vaccine for Recurrent Glioblastoma Multiforme (PVS-RIPO).
脊髓灰质炎病毒疫苗（pvs-ripo）治疗复发性多形性胶质母细胞瘤。
Duke University, Durham, North Carolina, United States. Phase I. Estimated primary completion date: January 2017. Bevacizumab not allowed less than 4 weeks prior to PVS-RIPO infusion.
NCT01491893
IMMUNE ENHANCING DRUGS – RECURRENT
免疫增强药物-复发性
A Pilot Study to Evaluate the Feasibility of the Combined Use of Stereotactic Radiosurgery (Gamma knife) With Nivolumab and Concurrent Valproate in Patients With Recurrent Glioblastoma.
使用定向放射治疗联合可行性伽玛刀、nivolumab和丙戊酸钠治疗复发性胶质母细胞瘤患者的初步研究。
University of Virginia. Estimated primary completion date: February 2018.
NCT02648633
A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers.
fpa008联合Nivolumab治疗晚期癌症患者的一期1a或1b期临床研究。
Detroit MI, San Antonio TX. Estimated primary completion date: March 2018.
NCT02526017
GENE THERAPY – RECURRENT
基因治疗-复发性
Phase II Study of Combined Temozolomide and Targeted P53 Gene Therapy (SGT-53) for Treatment of Patients With Recurrent Glioblastoma.
联合替莫唑胺和p53基因（sgt-53）的靶向治疗复发性胶质母细胞瘤患者的II期研究。
Houston TX. Estimated primary completion date: December 2016.
Prior chemotherapy for recurrent GBM with nitrosourea compounds including Gliadel® wafers or bevacizumab excluded
NCT02340156
OTHER
其他
An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 (Perillyl alcohol) in Recurrent Grade IV Glioma.
使用剂量递增的neo100（紫苏醇）剂量治疗IV级胶质瘤复发患者的一项开放的1 / 2A期临床试验，评估疗效及安全性。
Currently recruiting in Cleveland OH. Not yet recruiting at University of Southern California (Los Angeles), Seattle WA, Madison WI. Estimated primary completion date: June 2018.
NCT02704858
Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma.
使用Sym004治疗成人复发性胶质母细胞瘤患者的2期临床研究。
“The purpose of this study is to assess the activity of Sym004, a recombinant antibody mixture that specifically binds to EGFR, in patients diagnosed with recurrent glioblastoma whose tumor is EGFR amplified.” Duke University. Estimated primary completion date: October 2018.
NCT02540161
NOT YET RECRUITING
尚未招募
A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent Glioblastoma.
使用Toll样受体激动剂辅助的肿瘤相关抗原（TAA）混合Montanide isa-51 VG和Bevacizumab联用治疗复发性胶质母细胞瘤患者。
New York NY.
NCT02754362
Placebo-controlled
A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Newly-Diagnosed Glioblastoma (ATTAC-II) .
使用病毒RNA负载的树突状细胞与破伤风白喉类毒素疫苗联合治疗新诊断的胶质母细胞瘤（attac-ii）的一项II期随机、双盲、安慰剂对照试验。
University of Florida, Gainesville. Study start date: March 2016. Estimated primary completion date: March 2023.
NCT02465268
A Phase I Trial of Anti-LAG-3 or Anti-CD137 (Urelumab) Alone and in Combination With Anti-PD-1 in Patients With Recurrent GBM.
Anti-lag-3或抗CD137（urelumab）单独或联合抗PD-1抗体治疗复发性GBM患者的I期临床试验。
Study start date: March 2016. Birmingham AL, Los Angeles CA, San Francisco CA, Baltimore MD, New York NY, Winston-Salem NC, Cleveland OH, Philadelphia PA, Pittsburgh PA.
NCT02658981
相关报道：
[盘点]近期国内胶质瘤治疗临床试验与研究项目一览（六项以上）
- The End -
回复神经外科专家姓名，可查询以往专访及就医渠道
神外前沿：神经外科医学情报与就医平台
转载请注明出处；就医、内容、会议等合作请点击阅读原文；值班QQ2231686562