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Department of Neurosurgery

Clinical trials

The Department of Neurosurgery at Medical Center - University of Freiburg sets itself the goal to offer its brain tumor patients a wide range of treatment options according to the newest results and achievements in medical research. Therefore, the Department of Neurosurgery takes part in several national und international multi-center clinical trials and also performs investigator-initiated trials to improve the treatment of brain tumors and to obtain new information on the best treatment options for its patients. Thus, the Department of Neurosurgery can offer its patients treatment options with the newest pharmacological agents available within a clinical trial setting which are partly not yet approved on the German market.

The Department of Neurosurgery is in close co-operation with the German Register of Clinical Trials (DRKS).

Clinical trial assistant: Mrs. Nicole Koch

Following trials are currently conducted in Freiburg (updated in 2016):

Diffuse and anaplastic gliomas are intrinsic malignant tumors of the central nervous system affecting 3/100,000 adults per year. Despite modern therapeutic approaches involving operation, radiotherapy and chemotherapy with TMZ these tumors are incurable with a median overall survival of 4-7 years. This poor outcome is mainly due to inherent malignant progression and secondary resistance to genotoxic therapies. A principle characteristic largely contributing to this aggressive biology is the highly invasive behavior, which allows the active evasion of glioma cells from the main tumor mass not only into the surrounding but also into distant normal brain tissue.

Effective therapeutic measures need to take into account both, distant tumor spread and secondary resistance to genotoxic therapies. Remarkably, these tumors may remain stable without clinical impairment of the affected patients for many years. Recurrence and malignant transformation, however, are inevitable. To date, there are no effective measures preventing recurrence and/or malignant transformation. Achieving an effective prevention by stimulating the immune system to control transformed tumor cells could result in long-term remission of the disease.

The aim of this phase I trial is to evaluate the safety and tolerability of and immune response to the IDH1 peptide vaccine in patients with IDH1R132H-mutated gliomas without 1p/19qco-deletion and with loss of ATRX.

Link to Trial document

This is a non-randomized, open, non-controlled phase II trial in which 10 neuro-oncology centers in Germany take part. The trials aim is to evaluate a new radiochemotherapy regimen with the C protein-kinase-inhibitor Enzastaurin as primary therapy for patients with glioblastomas after microsurgical treatment. Those patients whose tumor material was tested as having a "non-methylated MGMT promoter status" receive Enzastaurin as caplets before, during and after radiation twice a day. This therapy will be performed as long as the tumor responds to this treatment. According to standard regulations, clinical examinations und MRI scans are performed regularly and records are kept on possible side effects.
The trial is closed. 6 patients were randomized in our center.

Link to Trial document

The Centric trial is a world-wide randomized, open, controlled phase II trial to examine the Integrin-Inhibitor Cilengitide in combination with standard therapy (radiochemo therapy as per Stupp protocol) in comparison to standard therapy alone for patients with a newly diagnosed glioblastoma with a "methylated MGMT promoter status". Patients who were diagnosed with glioblastoma and have been micro-surgically treated and proven to have a "methylated MGMT promoter" are included.

The Centric trial is a world-wide multi-center trial which started in October 2008. The division of the patients into a treatment group and a control group is done by drawing lots (randomization). Cilengitide is exhibited as a one-hour lasting infusion twice a week. The chemotherapy with Temozolomide (Temodal®) is performed according to standard protocol simultaneously with radiation, thereafter in 6 cycles over a 6 months-period.  It is a global, multi-center study, which was launched in October 2008 and closed on 30.06.2013. Our center had randomized 10 patients.

Link to Trial document

This is a one-armed pilot study for the treatment of 30 patients all over Germany with a newly diagnosed medulloblastoma in adults. Medulloblastomas in adults are fairly rare and make only 1% of all brain tumors in adults. They develop from embryonic cells and build tumors mainly in the posterior fossa. The first step of therapy is surgery. After histologic proof of medulloblastoma, the patients in the NOA-07-trial are treated with radiation therapy over a period of 6½ weeks as well as a 48 weeks lasting "maintenance chemotherapy". Simultaneously to radiation therapy, Vincristin is given intravenously once a week. The "maintenance therapy" which is performed in 8 cycles at the most, is composed of CCNU as tablets as well as Cisplatin and Vincristin as infusions. 30 patients who have completed their 18th year of age and are histologic proven to have a medulloblastoma are included. The trial was started in 2008. Three patients of our clinic were included. The study has been closed since May 2014.

Link to Trial document

This is an NOA associated prospective, randomized Phase II multicenter study of Hoffmann-La Roche AG, for patients with primary glioblastoma with a non-methylated MGMT promoter. In this two-armed study the effect of bevacizumab and irinotecan compared to standard therapy (radiation chemotherapy and adjuvant 6 cycles of temozolomide) was tested after microsurgical resection. Bevacizumab is an angiogenesis inhibitor, i.e. an antibody which inhibits neovascularization. Thus, the fast-growing tumors cannot be supplied with enough oxygen and nutrients and "starve". Irinotecan belongs to the group of the topoisomerase inhibitors. Irinotecan inhibits DNA topoisomerase I, which regulates the spatial arrangement of the DNA. The pathologically increased cell division of tumors is reduced by inhibiting topoisomerase I because its activity is increased in many tumors. The study is closed. 19 patients of our department are included.

Link to trial document

In this Phase II study for patients with non-methylated MGMT promoter the effect of temsirolimus is compared with temozolomide. For this purpose, patients in the standard arm are treated with the standard radio-chemotherapy treatment (temozolomide, Stupp protocol), in the experimental arm patients are treated with temsirolimus instead of temozolomide. In the experimental arm a weekly infusion treatment with temsirolimus at the study center is required. Temsirolimus is an inhibitor of mTOR. This enzyme occuring in all mammals is important for survival, growth, proliferation and motility of cells. The study is now closed. Two patients of our department were included.

Link to trial document

This is a multicenter randomized phase III trial for patients with newly diagnosed glioblastoma with a methylated MGMT promoter, comparing the combination therapy of lomustine (CCNU) / temozolomide with the standard temozolomide therapy after microsurgical resection. In both treatment arms radiation therapy is performed in addition. In an earlier Phase II trial it was found that a primary combination therapy of CCNU and temozolomide was highly effective and superior to temozolomide monotherapy. Chemotherapy is given orally. There are no infusions necessary. The study is closed. 3 patients of our department were included.

Link to trial document

The prospective randomized multicenter trial is conducted in the department of radiation oncology under the leadership of Mrs. Prof. Dr. A. Grosu and compares the efficacy of PET and MRI-based Re-irradiation in patients with relapse-glioblastoma. 7 randomized patients were included in this trail.

Link to trial document (GLIAA pilot trial)

Contact

Prof. Dr. Oliver Schnell, MHBA

Prof. Dr. Oliver Schnell, MHBA
Deputy Medical Director

Prof. Dr. Marcia Machein

Prof. Dr. Marcia Machein
Head consultation hours
for tumor patients