European Clinical Trial Report
The last several months have been very interesting in the neuro-oncological field in Europe. EANS meeting in Glasgow 2.-7.9.2007 gave a good overview of the current status.
The phase III multicenter study using adenovirus-mediated TK-gene transfer in primary glioblastom patients (Cerepro) completed its enrolment in May 2007. The interim analysis in June showed no concerns regarding safety, and no statistical difference between study and control group yet. The next interim analysis will be done in December.
British colleagues showed interesting first result from a mobile intraoperative radiotherapy devise (Liaquat).
Tumor vaccination with autologous dendritic cells for relapsed high grade glioma patients showed promising results, especially in young patients (De Vleeschouwer, Belgium, multicentre study with Germany and MD Anderson Cancer Center)
Finland continued the phase II study using boron neutron capture therapy for skull base malignant tumors (Kouri, Mäenpää, Helsinki).
The following list shows the activity in the field, but is not definite. I hope to get a response from my European colleagues and a complete list of the ongoing clinical neuro-oncological studies into my next report.
My best regards,
A phase I study of cisplatin, temozolomide and thalidomide in patients with malignant brain tumours.
Zustovich F. Padova, Italy
Temozolomide and thalidomide in the treatment of glioblastoma multiforme
Riva M, Milan, Italy
Phase 2b Study in recurrent of refractoy gb patients with the TGF- 6etq- 2 inhibitor AP 12005.
P. Han, Regensburg, Germany
Single center phase 2 trial analysing. The role of imatinib/ hydroyurea in pts with pretreated non- progressive globlastoma as maintenance treatment.
G. Dresemann, Dülmen, Germany
Gliogene- to identify susceptibility genes in high- risk factor brain tumors
MD Anderson Cancer Center, Multicenter America/ Europe
Phase 1 trial of Tipifarnib (R115777) Concurrent with Radiotherapy in Patients with Glioblastome Multiforme. Cohen- Jonathan Myal E Toulouse, France
Salvage chemotherapy with procarbazine and fotemustire combinatory in the treatment of temozolomide treated recurrent glioblastoma patients.
Silvani A, Milan, Italy
Bombesin and FDG- PET in the follow up of patients with low grade gliomas for to differentiate between malignant transformation and tumour
M. Seiz, University Hospital Mannheim Germany
Controlled, randomised, paralled group, multicentre study of the efficacy and safety of Cerepro TM with ganciclovir for operable high- grade glioma
Comparison from concomitant therapy and alternative protocol in newly diagnosed glioblastoma: (TMZ, chemo-radiotherapy)
Survival and quality of life. M. Caroli. Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Italy
Methvsalem (NOA-08) (Phase III, Multicenterstudy; Status: open)
Temozolomid (one week on/one week off) vs. radiation as a primary therapy in elderly patients with anaplastic astrocytom
Cilengitide (EMD121974) and temozolomide with concomitant radiation therapy, followed by cilentigide and temozolomide maintenance therapy in subjects with newly diagnosed glioblastoma multiforme (Phase I/IIa, Multicenterstudy; Status: offen)
NOA- 06 (Phase III, Multicenterstudie; Status: open)
Prospective randomised phase III study by solitare/singular brain metastases: operation vs. operation with whole brain radiation.
Neoadjuvant Targeting of High and Low Grade Gliomas with Radiolabelled Substance P- a Phase I Study
Cordier, D (Switzerland)
Postoperative DC Vaccination for Relapsed High Grade Glioma: a Large, Prospective Longterm, Cohort Comparison Trial
De Vleeschouwer, S (Belgium)
Mobile Intraoperative Radiotherapy in Malignant Brain tumours,
Liaquat, I (UK)
Stereotactic Interstitial Photodynamic Therapy (IPDT) of Circumscribed Malignant Gliomas using 5- aminolevulinic Acid (5-ala) Mehrkens, J (Germany)
EORTC 26052/22053: Phase III trial comparing conventional adjuvant temozolomide with doseintensive temozolomide in patients with newly diagnosed glioblastoma (RTOG0525) study now open to patient accrual
EORTC 26062-22062 (NCI- C CE.6) GBM in elderly patients
EORTC 26041/22041: Phase I/II study in concomitant and adjuvant TMZ/RT with or without PTK787
EORTC 26053-22054 Phase III trial on concurrent and adjuvant temozolomide chemotherapy in non-1p/19q deleted anaplastic glioma. The CATNON Intergroup Trial
EORTC 22033/26033 (NCI-C CE.5): Evaluating primary chemotherapy with temozolomide vs. radiotherapy in patients with low grade gliomas with stratification for genetic 1p/19q loss: a phase III study. Study open.
EORTC 16027/26023: TMZ plus Lonafarnib, phase I in Lausanne, Nantes and Dijon
EORTC 26021: Phase II study of ZK219477 in patients with recurrent glioblastoma; study now open to patient accrual, 1 site authorized
EORTC 26054: Phase I study of LY317615 (Enzastaurin) and temozolomide in patients with gliomas
EORTC 22042-26042: Adjuvant postoperative high-dose radiotherapy for atypical and malignant meningioma: a phase II trial (D. Weber)
EORTC 22952-26001: No radiotherapy versus whole brain radiotherapy for 1-3 brain metastases from solid tumour after surgical resection or radiosurgery. Randomized phase III trial. (R.Soffietti)
BNCT phase II study for malignant tumours of the scull base (glioblastoma, anaplastic astrocytoma), Mäenpää, Helsinki, Finland
BNCT as Treatment of Glioblastoma, Kouri, Helsinki, Finland