Currently Recruiting Clinical Trials - Glioblastoma (short list)

by Stephen Western
Astrocytoma Options.com

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This page is not a complete listing, but represents a selection of some of the most interesting trials with a focus on immunotherapy. The page has been divided into two major sections - newly diagnosed and recurrent/progressive. The trials for recurrences are found on the bottom half of the page. Additional trials for glioblastoma also found on Currently Recruiting Trials - High Grade Glioma.

New Trials (added here in the last month)

Added October 5, 2015
Randomized, open-label
Evaluation of Overcoming Limited Migration and Enhancing Cytomegalovirus-specific Dendritic Cell Vaccines With Adjuvant Tetanus Pre-conditioning in Patients With Newly-diagnosed Glioblastoma. 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 saline.
NCT02366728

Added September 24, 2015
Phase I/II Trial of Radiation Therapy Plus Temozolomide With MK-3475 (Pembrolizumab) in Patients With Newly Diagnosed Glioblastoma. Chicago IL. Study start date: September 2015. Estimated primary completion date: March 2018.
NCT02530502

Newly diagnosed

Vaccines - Newly diagnosed

REGULATory T-Cell Inhibition With Basiliximab (Simulect®) During Recovery From Therapeutic Temozolomide-induced Lymphopenia During Antitumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed Glioblastoma Multiforme. Phase I. Duke University. Estimated primary completion date: March 2016. "Our pilot group of 7 pts that received DC CMV vaccine with one dose of anti-CD25 antibody (basiliximab) had median progression free survival (PFS) and overall survival (OS) of 23.5 months and 30.3 months respectively. There were no adverse events associated with the vaccine or anti-CD25 Ab therapy."
Abstract
NCT00626483

Randomized, open-label
Evaluation of Overcoming Limited Migration and Enhancing Cytomegalovirus-specific Dendritic Cell Vaccines With Adjuvant Tetanus Pre-conditioning in Patients With Newly-diagnosed Glioblastoma. 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 saline.
NCT02366728

Placebo-controlled
A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The Treatment Of Glioblastoma Multiforme. This therapy, described on the DCVax page, showed impressive efficacy in earlier phase I trials. The current phase III trial, conducted by Northwest Biotherapeutics, is recruiting at 77 study locations (mostly in the US with additional locations in Montreal and Sherbrooke, Quebec, Canada; Dresden, Chemnitz, Halle, Hamburg, and Stuttgart, Germany; and Birmingham, Cambridge, and London UK). Patients joining this trial must have sufficient tumor material available from surgery to create the vaccine, and must undergo standard radiochemotherapy. Patients are randomized into two groups: one group receives injections of their own peripheral blood mononuclear (white blood) cells following radiochemotherapy (control arm); the other group receives the DCVax-L vaccine, in which the patients' dendritic cells are trained to recognize tumor antigens by co-culture with tissue from the patients' tumor. Information from an August 11, 2014 press release revealed that modifications were being made to the trial, extending enrollment until the third quarter of 2015. Estimated primary completion date: September 2015.
NCT00045968

An Expanded Access Protocol for the Treatment of Glioblastoma Multiforme in Patients With Already Manufactured DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen Who Have Screen-Failed Protocol 020221. 10 locations across the USA. Protocol 020221 refers to the phase III trial described above.
NCT02146066

A Phase II Study of the Safety and Efficacy of SVN53-67/M57-KLH (SurVaxM) in Survivin-Positive Newly Diagnosed Glioblastoma. Buffalo NY. Not yet recruiting in Cleveland OH. Estimated primary completion date: April 2017.
NCT02455557

Intradermal IMA950 Peptide-based Vaccine Adjuvanted With Intra Muscular Poly-ICLC in Combination With Temozolomide in Newly Diagnosed HLA-A2 Glioblastoma Patients. Phase I/II. The University Hospital in Geneva Switzerland is sponsoring this trial, in collaboration with immatics biotechnologies (the maker of the IMA950 vaccine) and Oncovir (maker of Poly-ICLC aka Hiltonol). IMA950 consists of 11 synthetic tumour-associated peptides, and is expected to promote cytotoxic T lymphocyte (CTL) and T helper cell immune responses against tumour cells expressing these antigens. Two other phase I trials, one in the UK and one in the US, are also investigating the IMA950 vaccine for glioblastoma. Patients in this trial will receive standard radiochemotherapy, in addition to the IMA950 vaccine and Poly-ICLC, an immune activator described briefly on the Immunotherapy page. Estimated primary completion date: December 2015.
NCT01920191

A Phase I Study of a Personalized NeoAntigen Cancer Vaccine With Radiotherapy Among MGMT Unmethylated, Newly Diagnosed Glioblastoma Patients. Boston MA (Dana Farber Cancer Institute). Estimated primary completion date: January 2018.
NCT02287428

Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Newly Diagnosed Glioblastoma. Mayo Clinic, Rochester MN, USA. Estimated primary completion date: December 2015. Allogeneic tumour lysate.
NCT01957956

Vaccination With Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line. This phase I 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). Recruiting in Heidelberg and Tübingen, Germany; Barcelona, Spain; Leiden, Netherlands; Geneva, Switzerland. Estimated primary completion date: July 2018.
NCT02149225

T-cells

Pilot Study of Autologous T Cells Redirected to EGFRVIII-With a Chimeric Antigen Receptor in Patients With EGFRVIII+ Glioblastoma. Philadelphia PA, San Francisco CA. Estimated primary completion date: July 2016. For patients at first recurrence or with residual disease following surgery.
NCT02209376

Immune checkpoint inhibitors

Phase I/II Trial of Radiation Therapy Plus Temozolomide With MK-3475 (Pembrolizumab) in Patients With Newly Diagnosed Glioblastoma. 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. 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. Bethesda MD, Philadelphia PA, Houston TX. Estimated primary completion date: May 2016.
NCT02311920

Suicide gene and immune-mediated gene therapy hybrid

Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma (Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L gene therapy). Phase I. 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

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. Cleveland, Ohio, USA. Estimated primary completion date: November 2015.
NCT00752323

More trials of fluorescence-guided resection found on Currently Recruiting Trials for High Grade Glioma.

Recurrent and progressive

Vaccines - recurrent

Vaccination With Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line. This phase I 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.
NCT02010606

Cancer Vaccine ICT-121 in Recurrent Glioblastoma. Phase I. In a press release dated December 23, 2013, ImmunoCellular Therapeutics announced that the first patient in a phase I trail of their ICT-121 vaccine was treated at Cedars-Sinai. Eligible patients in this safety and tolerability trial must have had gross total resection of their tumour, a single tumour recurrence, and be HLA-A2 (human leukocyte antigen A2) positive. Patients will undergo leukapheresis to draw dendritic cell precursors from the blood. The dendritic cells are then pulsed with purified peptides from CD133. Patients will receive vaccine injections once a week for 4 weeks, followed by once every 2 months until their vaccine supply is depleted or they experience disease progression. This vaccine targets CD133, an antigen commonly expressed on glioblastoma stem cells. Recruiting in Birmingham AL, San Diego CA, Los Angeles CA, Edison NJ, Hershey PA, Dallas TX. Estimated primary completion date: December 2015.
NCT02049489

Randomized, open-label
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. 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.
NCT01814813

A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients With Recurrent Glioblastoma Multiforme. Birmingham AL, Phoenix and Tucson AZ, Los Angeles and San Francisco CA, Washington DC, Atlanta GA, Chicago IL, Boston and Worcester MA, Detroit MI, Minneapolis MN, Lake Success and New York NY, Winston-Salem NC, Cleveland OH, Pittsburgh PA, Charleston SC, Dallas TX, Charlottesville VA, Milwaukee WI. Estimated primary completion date: March 2016. Recruitment temporarily on hold (summer 2015).
NCT02078648

Placebo-controlled
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. University of California, Irvine. Estimated primary completion date: March 2016. For recurrent/progressive, bevacizumab-naïve glioblastoma multiforme and gliosarcoma.
NCT01903330

Oncolytic Virotherapy Trials - Recurrent

A Phase 1b, Randomized, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) and Interferon Gamma (IFN-?) for Recurrent Glioblastoma or Gliosarcoma (TARGET-I). Tampa FL. Estimated primary completion date: August 2017.
NCT02197169

Virus DNX2401 and Temozolomide in Recurrent Glioblastoma. Pamplona, Spain. Phase I. Estimated primary completion date: December 2015.
NCT01956734

Poliovirus Vaccine for Recurrent Glioblastoma Multiforme (PVS-RIPO). Duke University, Durham, North Carolina, United States. Phase I. Estimated primary completion date: January 2016.
NCT01491893

Measles Virus Derivative (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme. Mayo Clinic, Rochester, Minnesota, United States. Phase I. Estimated primary completion date: June 2015.
NCT00390299

T-cells - Recurrent

Pilot Study of Autologous T Cells Redirected to EGFRVIII-With a Chimeric Antigen Receptor in Patients With EGFRVIII+ Glioblastoma. Philadelphia, Pennsylvania. Estimated primary completion date: July 2016. For patients at first recurrence or with residual disease following surgery.
NCT02209376

Immune checkpoint inhibitors - Recurrent

Randomized, open-label
A Randomized Phase 3 Open Label Study of Nivolumab Versus Bevacizumab and a Safety Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Adult Subjects With Recurrent Glioblastoma (GBM). Phase II. Recruiting in USA, Australia, Belgium, Canada, Denmark, Germany, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom. Estimated primary completion date: June 2017.
NCT02017717

Phase 2 Study to Evaluate the Clinical Efficacy and Safety of MEDI4736 (anti–PD-L1 antibody) in Patients With Glioblastoma. 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

Randomized, open-label
Phase II Study of Pembrolizumab (MK-3475) With and Without Bevacizumab for Recurrent Glioblastoma. Boston MA. Estimated primary completion date: February 2017.
NCT02337491

Open-label
Phase IIb Trial Evaluations Of The Effectiveness Of Treatment Glioblastoma / Gliosarcoma Through The Suppression Of The PI3K/Akt Pathway In Compared With MK-3475 (Pembrolizumab). Boston MA, Houston TX, Belgium, Germany, Italy, Poland, Russia, Spain, Switzerland, Ukraine (by invitation), Northern Ireland. Estimated study completion date: June 2018.
NCT02430363

Anti PD1 Antibody (pidilizumab) in Diffuse Intrinsic Pontine Glioma and Relapsed Glioblastoma Multiforme. Phase I/II. Israel. Estimated primary completion date: November 2015.
NCT01952769

Gene therapy - Recurrent

Phase II Study of Combined Temozolomide and Targeted P53 Gene Therapy (SGT-53) for Treatment of Patients With Recurrent Glioblastoma. Houston TX. Estimated primary completion date: December 2016.
NCT02340156

This page was created on 01/18/2014 and last updated on 04/19/2020