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Studies

Here you will find an overview of studies that are currently being conducted in Germany as part of the initial and recurrent diagnosis of glioblastoma.

Information

In many treatment centers in Germany as well as in Europe, clinical studies are offered in the context of glioblastoma therapy.

  • Monocentric „The study takes place in a clinic
  • Multi-center „The study is being conducted in several hospitals“
  • Randomization „Patients are assigned to a therapy or control arm using the randomization mechanism“

Patients diagnosed with glioblastoma thus have the opportunity to benefit from new experimental therapeutic approaches that are otherwise not yet available in regular treatment. 

It should be noted that the hope for a better quality of life or for a cure must be weighed against the risk of possible side effects, as there is usually no extensive experience with experimental therapeutic approaches.

Experimental therapy approaches in the form of clinical trials are not experiments on humans. Patient safety is and must be guaranteed at all times. The preclinical tests (laboratory and animal experiments), which are the starting points of the study protocol, are followed by three phases of clinical trials: 

  • In Phase I (toxicity test), the toxicity and tolerability of a new substance is investigated in very few patients.
  • In Phase II (efficacy test), the mode of action, the method of application and the dose are tested on a larger group of patients.
  • In phase III (comparison with established methods), a large number of patients are tested to determine whether the new therapy is superior.

If the results of all three phases demonstrate safety and efficacy of a therapy, an application for approval will be submitted.

The authors of www.glioblastom-therapie.de would like to encourage all patients to inform themselves about the possibility of participating in clinical trials. By participating in studies you create knowledge for optimal education and therapy of future patients with the same diagnosis.

Clinical studies for diagnosis of glioblastoma

(In the following clinical studies without claim to completeness)

Here you will find an overview of all studies that are currently enrolling or will soon recruit patients in the context of initial and recurrent diagnosis of glioblastoma in Germany. The website is updated regularly. Should you miss a study here, please feel free to contact us so that it can be included in the overview.

(current status: 08.11.2020). 

Update Studies

The Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma (NOA11) study is now recruiting patients. It is aimed at patients in the rezidiv situation.

You can find more information here. 

Clinical studies for first diagnosis
Recruiting at present

Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma (Gamma-GBM)

After tumor resection, the remaining tumor is stereotactically irradiated within 24-72 hours using the Gamma Knife. The usual standard therapy follows

Study design: Phase II, monocentric, single-arm, non-randomized
https://clinicaltrials.gov/ct2/show/NCT03055208

Immunophenotyping From Blood of Patients With Malignant Gliomas

At several points in time before, during and after tumor therapy, blood is taken and examined for the composition of immune cells. The aim is to gain information about the effectiveness of the individual therapy steps with regard to immunological processes and their course. 

Study design: observational study, monocentric
https://clinicaltrials.gov/ct2/show/NCT02022384

Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients (GLORIA)

In patients in whom a complete resection of the glioblastoma was not possible, a combination of a drug (Olaptesed Pegol), which is directed against a certain factor (stromal cell-derived factor 1 = SDF-1) and is supposed to have an anti-tumoral effect, is administered postoperatively in combination with radiotherapy.

Study design: Phase I/II, single-arm, multicenter
https://clinicaltrials.gov/ct2/show/NCT04121455

Efficiency of Vaccination With Lysate-loaded Dendritic Cells in Patients With Newly Diagnosed Glioblastoma (GlioVax)

From the tumor tissue removed during the operation as well as a blood sample, the body’s own defense cells (so-called dentritic cells) are obtained, which are prepared in the form of a vaccination and subsequently administered to the patient.
The aim is to stimulate the patient’s own immune response against the tumor. The vaccination is administered in addition to the standard therapy. Patients in the control arm receive only the standard therapy. 

Study design: multicenter, randomized, two-armed, Phase II
https://clinicaltrials.gov/ct2/show/NCT03395587

Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme (INTRAGO-II)

After tumor resection, the tumor cavity is immediately irradiated intraoperatively. Afterwards, the patient is transferred to standard therapy. Patients in the control arm receive only the standard therapy. 

Study design: multicenter, randomized, two-arming, phase III
https://clinicaltrials.gov/ct2/show/NCT02685605

Molecular Genetic, Host-derived and Clinical Determinants of Long-term Survival in Glioblastoma

In patients who are alive for more than 5 years after initial diagnosis of glioblastoma, numerous data are being collected to exclude possible factors for long-term survival.

Study design: clinical epidemiological study, pro- and retrospective, multicenter
https://clinicaltrials.gov/ct2/show/NCT03770468

A Phase III Trial of With Marizomib in Patients With Newly Diagnosed Glioblastoma (MIRAGE)

Marizomib is administered in addition to the standard therapy. Marizomib is effective against certain structures in the cell
(so-called proteasome inhibitor) and has long been investigated in clinical trials for its anti-tumoral effect on various tumors. Patients in the control arm receive only the standard therapy. 


Study design: multicenter, randomized, two-armed, phase III

https://clinicaltrials.gov/ct2/show/NCT03345095

NCT Neuro Master Match – N²M² (NOA-20) (N²M²)

Patients with MGMT-unmethylated glioblastoma undergo comprehensive molecular testing of the tumor and then a targeted therapy is assigned according to the individual molecular tumor profile. Various substances, including immunomodulating therapeutics, are used. As a rule, the drug therapy is accompanied by radiotherapy. 

Study design: Phase I/IIa, multicenter
https://clinicaltrials.gov/ct2/show/NCT03158389
https://www.neuroonkologie.de/studien

Retest-Reliabilität und lokalisationsabhängige Sensitivität neurocognitiver Testung bei erstdiagnostizierten Glioblastompatienten (Re-Cog-GBM-L)

Neurocognitive tests are carried out on the patient before and during the course of the operation. The aim is to detect and analyze neurocognitive changes associated with surgery and therapy.

Study design: Observation study, multicenter
https://www.neuroonkologie.de/studien

Pivotal, Randomized, Open-label Study of Optune® (Tumor Treating Fields) Concomitant With RT & TMZ for the Treatment of Newly Diagnosed GBM (EF-32)

The aim of this study is to analyze the effectiveness and safety of tumor treating fields parallel to combined chemoradiotherapy in patients with newly diagnosed glioblastoma compared to combined chemoradiotherapy alone. The aim is to obtain data on a possible advantage of the earlier introduction of tumor treatment fields.

Study design: prospective, open-label, randomized study, two-armed, multi-center
https://clinicaltrials.gov/ct2/show/NCT04471844?recrs=ab&cond=glioblastoma&cntry=DE&draw=3&rank=19

Active, not recruiting yet

Effect of Timing of Tumor-Treating Fields Plus Short-Course Radiation (GERAS)

In patients (> 70 years) the applicability and the simultaneous or delayed use of tumor therapy fields for hypofractionated radiotherapy will be analyzed.

Study design: Phase II, randomized, two-armed
https://clinicaltrials.gov/ct2/show/NCT04218019

TIGER PRO-Active – Daily Activity, Sleep and Neurocognitive Functioning Study

The aim of this study is to investigate cognitive function, sleep quality and activity in daily life as important determinants of quality of life in a cohort of glioblastoma patients who are treated with tumor treating fields. Patients with newly diagnosed glioblastoma who have completed chemoradiotherapy and are within the first 3 cycles of adjuvant chemotherapy can be included.

Study design: prospective observational study, single center
https://clinicaltrials.gov/ct2/show/NCT04717739?recrs=ab&cond=glioblastoma&cntry=DE&draw=2&rank=3

PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma

After application of 5-ALA (5-aminolevulinic acid), the substance accumulates specifically in tumor tissue and ensures that the tissue becomes photosensitive. A laser probe is inserted into the tumor by means of stereotaxy and the surrounding, light-sensitive tumor tissue is attacked by the laser effect

Study design: Phase II, multicenter, single-arm
https://clinicaltrials.gov/ct2/show/NCT03897491

Clinical studies for recurrence diagnosis

Currently recruiting

Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma (NOA11)

In the therapy arm, photodynamic therapy (PDT) is carried out in the event of tumor recurrence followed by a stereotactic biopsy. Here, 5-ALA (5-aminolevulinic acid) is used. All patients in the therapy arm receive this substance a few hours prior to surgery. 5-ALA is currently approved for fluorescence-guided resection of malignant gliomas and is used there as standard. The aim is to improve the extent of resection. 5-ALA is selectively taken up by tumor cells and converted into protoporphyrin IX (PPIX), a strongly fluorescent substance. This phenomenon leads to selective tumor cell fluorescence.

In addition to tumor visualization and thus better resection conditions, the metabolites of 5-ALA make the tumor tissue very sensitive to light. This phenomenon is used in photodynamic therapy. As part of PDT, after a stereotactic biopsy has been taken from the tumor, a laser probe is stereotactically inserted into the tumor. The aim of the therapy is to selectively destroy the tumor tissue that has been sensitized to light by means of 5-ALA.

In the controll arm, there are only taken biopsies for the purpose of confirming the diagnosis of a relapse. In both arms surgery is followed by second-line therapy in accordance with the neuro-oncological recommendations.

Study design: phase II, randomized, multicenter, two-armed
https://clinicaltrials.gov/ct2/show/NCT04469699
https://www.neuroonkologie.de/studien

Adjuvant Stereotactic Fractionated Radiotherapy to the Resection Cavity in Recurrent Glioblastoma (GlioCave/NOA17)

After complete resection of the recurrent tumor, stereotactically guided radiation treatment of the tumor cavity is performed in the therapy arm. The administration of chemotherapy is not part of the study protocol and can be administered in both study arms. 

Study design: multicenter, randomized, Phase II, two-armed
https://clinicaltrials.gov/ct2/show/NCT02715297
https://www.neuroonkologie.de/studien

Intracranial Injection of NK-92/5.28.z Cells in Patients With Recurrent HER2-positive Glioblastoma (CAR2BRAIN)

In this study genetically modified natural killer cells (NK-92 cells) are injected into the tumor cavity after resection of the recurrent tumor. These cells were genetically modified and provided with a chimeric antigen receptor (CAR). This receptor enables the attack of specific tumor antigens (HER2). A prerequisite is that the glioblastoma is HER2 positive (approx. 40% of all tumors). 

Study design: multicenter, Phase I
https://clinicaltrials.gov/ct2/show/NCT03383978
https://www.kgu.de/einrichtungen/kliniken/zentrum-der-neurologie-und-neurochirurgie/dr-senckenbergisches-institut-fuer-neuroonkologie/krankenversorgung/studienzentrale/car2brain-studie/

VXM01 Plus Avelumab Combination Study in Progressive Glioblastoma

This is a study in the field of immunotherapy, which analyzes the efficacy and tolerability of two immunotherapeutics VXM01 (VEGFR-2 DNA vaccine) and Avelumab (anti-PD-L1 antibody) in patients with resectable and non-resectable recurrent tumors.

Study design: Phase I/II, multicenter
https://clinicaltrials.gov/ct2/show/NCT03750071

Surgery for Recurrent Glioblastoma (RESURGE)

In this study, the efficacy of recurrent tumor resection followed by second-line therapy will be compared to second-line therapy alone.

Study design: randomized, phase II, multicenter, two-armed
https://clinicaltrials.gov/ct2/show/NCT02394626

Study of TG02 in Elderly Newly Diagnosed or Adult Relapsed Patients With Anaplastic Astrocytoma or Glioblastoma (STEAM)

Patients > 65 years of age with recurrent tumor are assigned to one of 3 study arms depending on the molecular status of the tumor and receive TGO2 in combination with temozolomide, radiotherapy or alone. TG02 (zotiraciclib) is a kinase inhibitor. Kinases are endogenous proteins that the tumor needs for growth. 

Study design: non-randomized, 3-arm, phase Ib, multicenter
https://clinicaltrials.gov/ct2/show/NCT03224104

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)

This study is aimed at patients with various tumors in the recurrent situation, including glioblastomas. A combination therapy of two drugs is applied: Pembrolizumab (checkpoint inhibitor, PD-1 antibody) and lenvatinib (multiple kinase inhibitor). Kinases are endogenous proteins that the tumor needs for growth.

Study design: Phase II, non-randomized, single-arm, multicenter
https://clinicaltrials.gov/ct2/show/NCT03797326

AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma (AMPLIFY-NEOVAC)

This study is directed at patients with IDH-mutated glioma WHO grade II-IV in recurrent situation. There are three arms in the study: patients receive either an IDH-1 vaccination, the immunotherapeutic agent Avelumab (checkpoint inhibitor, PD-L1 antibody) or a combination of both. This therapy is followed by surgical resection of the recurrent tumor with subsequent continuation of the assigned therapy.

Study design: Phase I, multicenter, randomized
https://clinicaltrials.gov/ct2/show/NCT03893903

Vaccines in Patients With Progressive Glioblastoma (ROSALIE)

In this study, a vaccination against a specific surface feature of the tumor alone or in combination with the immunotherapeutic agent nivolumab (checkpoint inhibitor, PD-1 antibody) is tested for safety and effectiveness in patients with recurrent glioblastoma.

Study design: Phase Ib/2a, non-randomized, multicenter
https://clinicaltrials.gov/ct2/show/NCT04116658

Amino-acid PET versus MRI guided re-irradiation in patients with recurrent glioblastoma multiforme – A randomised phase II trial. Prospektive, randomisierte multizentrische Phase-II-Studie (NOA-10 / GLIAA-Studie)

In this study, the significance of high-precision re-irradiation according to FET-PET versus high-precision MRI T1+KM re-irradiation is prospectively and randomized evaluated in patients with recurrent glioblastoma.

Active, not recruiting yet

Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma (NOA11)

In case of tumor recurrence followed by a stereotactically guided biopsy, photodynamic therapy is performed in the therapy arm. In the control arm, samples are only taken to confirm the diagnosis of recurrence. Subsequently, a second line therapy is performed according to neuro-oncological recommendations. 

Study design: Phase II, randomized, multicenter, two-arm
https://clinicaltrials.gov/ct2/show/NCT04469699
https://www.neuroonkologie.de/studien

First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma (ROSALIE)

In this study, a vaccination against a specific surface feature of the tumor alone or in combination with the immunotherapeutic agent nivolumab (checkpoint inhibitor, PD-1 antibody) is tested for safety and effectiveness in patients with recurrent glioblastoma.

Study design: Phase Ib/2a, non-randomized, multicenter
https://clinicaltrials.gov/ct2/show/NCT04116658

Update Studies

In the new section „Update Studies“ you will find all newly added studies.
This is intended to give you a better overview.

The authors of www.glioblastom-therapie.de would like to encourage all patients to inform themselves about the possibility of participating in clinical trials. By participating in studies, you create knowledge for optimal education and therapy of future patients with the same diagnosis.

(The following clinical studies are not exhaustive / updated 29.04.2021)

Clinical studies in recurrence diagnosis
Currently recruiting

In the therapy arm, photodynamic therapy (PDT) is performed in case of tumor recurrence followed by a stereotactically guided sample biopsy. 5-ALA (5-aminolevulinic acid) is used for this purpose. All patients in the therapy arm receive this substance a few hours before surgery. 5-ALA is currently approved for fluorescence-guided resection of malignant gliomas, where it is used as standard. The goal is to improve the extent of resection. 5-ALA is selectively taken up by tumor cells and converted to protoporphyrin IX (PPIX), a highly fluorescent substance. This phenomenon leads to selective tumor cell fluorescence.

In addition to tumor visualization and thus better resection conditions, the degradation products of 5-ALA make tumor tissue very sensitive to light. Photodynamic therapy takes advantage of this phenomenon. In PDT, a laser probe is inserted stereotactically into the tumor after a sample biopsy has been taken from the tumor. The aim of the therapy is to selectively destroy the tumor tissue made light-sensitive by 5-ALA.

In the control arm, only samples are taken to confirm the diagnosis of the recurrence. This is followed by a second-line therapy according to the neuro-oncological recommendation. 

Study design: Phase II, randomized, multicenter, two-arm study.

Clinical studies at first diagnosis
Currently recruiting

The aim of this study is to analyze the
To analyze the efficacy and safety of tumor therapy fields in parallel with combined radiochemotherapy in patients with newly diagnosed glioblastoma compared to combined radiochemotherapy alone. To obtain data on a possible advantage of earlier use of tumor therapy fields.

Study design: prospective, open-label, randomized, two-arm, multicenter study.

https://clinicaltrials.gov/ct2/show/NCT04471844?recrs=ab&cond=glioblastoma&cntry=DE&draw=3&rank=19

Clinical studies in recurrence diagnosis
active, not yet recruiting

This study will evaluate cognitive function, sleep quality, and activity in daily living as important determinants of quality of life in a cohort of glioblastoma patients treated with tumor therapy fields. Patients with newly-diagnosed glioblastoma who have completed radiochemotherapy and are within the first 3 cycles of adjuvant chemotherapy are eligible for inclusion.

Study design: prospective observational study, monocentric.

https://clinicaltrials.gov/ct2/show/NCT04717739?recrs=ab&cond=glioblastoma&cntry=DE&draw=2&rank=3

Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma (NOA11)

In the therapy arm, photodynamic therapy (PDT) is performed in case of tumor recurrence followed by a stereotactically guided sample biopsy. 5-ALA (5-aminolevulinic acid) is used for this purpose. All patients in the therapy arm receive this substance a few hours before surgery. 5-ALA is currently approved for fluorescence-guided resection of malignant gliomas, where it is used as standard. The goal is to improve the extent of resection. 5-ALA is selectively taken up by tumor cells and converted to protoporphyrin IX (PPIX), a highly fluorescent substance. This phenomenon leads to selective tumor cell fluorescence.

In addition to tumor visualization and thus better resection conditions, the degradation products of 5-ALA make tumor tissue very sensitive to light. Photodynamic therapy takes advantage of this phenomenon. In PDT, a laser probe is inserted stereotactically into the tumor after a sample biopsy has been taken from the tumor. The aim of the therapy is to selectively destroy the tumor tissue made light-sensitive by 5-ALA.

In the control arm, only samples are taken to confirm the diagnosis of the recurrence. This is followed by a second-line therapy according to the neuro-oncological recommendation. 

Study design: Phase II, randomized, multicenter, two-arm study.