-
Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme
In this phase I/II study,investigators are evaluating the feasibility and efficacy of the combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120 dose to be administered with a standard dose of bevacizumab will be determined in patients with refractory solid tumors. Although it is unlikely that the concurrent administration of bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will be performed on all patients treated during the Phase II portion of the study. Assuming this combination is feasible, the Phase II portion...
-
Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma
Despite the marginal improvements in survival of patients suffering from malignant glioma treated with gene therapy vectors, the clinical trials conducted so far using viral vectors, in particular adenoviral vectors, have proven that the use of adenoviral vectors is a safe therapeutic approach, even in large, multicenter, phase 3 clinical trials. Treatment of malignant glioma using gene transfer modalities typically consists of surgical debulking of the tumor mass followed by the administration of the viral vectors into the brain tissue surrounding the tumor cavity. This study will combine direct tumor cell killing (TK) and immune-mediated stimulatory (Flt3L) gene transfer...
-
Comparison of Different Methods to Test MGMT Status in Glioblastoma Patients
Treatment for newly diagnosed glioblastomas currently involves surgical resection followed by Temozolomide chemotherapy with concomitant radiotherapy, and then 6 cycles of Temozolomide in adjuvant. According to many studies, only those patients not expressing the enzyme repair MGMT benefit from the adjunction of Temozolomide. Therefore, many patients receive unnecessary treatment. The aim of this project is to compare different techniques for analysis of MGMT in order to choose the approach with the best cost/utility ratio, which will allow the selection of patients likely to respond to TMZ chemotherapy during the first course of GBM treatment.
-
Comparison of Standard Neuronavigation With Intraoperative Magnetic Resonance Imaging (MRI) for the Neurosurgical Treatment of Malignant Brain Tumors
The treatment of a specific subtype of highly malignant brain tumor (called "glioblastoma" or "glioblastoma multiforme") consists of neurosurgical resection, followed by radiotherapy and mostly chemotherapy as well. Increased extent of tumor resection is associated with prolonged survival. The standard treatment uses conventional neuronavigation systems to increase extent of tumor resection. However, the quality of this form of neuronavigation decreases throughout surgery because of "brain shift". This is caused by edema, loss of cerebrospinal fluid and tumor resection. A new form of neuronavigation uses intraoperative MRI to compensate for brain shift, and to check for the...
-
Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors
Study Objectives: Primary Objective: To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme. Secondary Objectives: To assess the safety of intratumoral/interstitial therapy with TransMID compared to best standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma multiforme. To evaluate possible differences in efficacy and/or safety with TransMID associated with differing degrees of transferrin receptor expression in tumor tissue and serum anti-diphtheria toxin antibody titer levels. Study...
-
Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma
For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity. In study arm A patients receive temozolomide for one week, followed by a week without temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a week without temozolomide. The regimen that is less toxic will be selected for further evaluations.
-
Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy that has been planned with a computer plus chemotherapy in treating patients who have glioblastoma multiforme.
-
Concomitant Association of Ultrafractionated Brain Irradiation - Temozolomide in Inoperable Primary Glioblastoma Multiforme
The main purpose of this study is the evaluation of concomitant association of ultrafractionated irradiation and Temodal® in patients with inoperable primary glioblastoma multiforme; study of tolerance and objective response rate. The secondary purposes of this study are the evaluation of progression free survival, global survival and tolerance through toxicity study. The therapeutic response according to methylation or not of MGMT is also evaluated.
-
Confocal Laser Endomicroscopy for Brain Tumors
The prognosis of glioblastoma patients highly depends on resection extent. Various strategies have been introduced to overcome the dilemma of intraoperative tumor identification. In gastroenterology, confocal laser endomicroscopy (CLE) allows precise differentiation of tumor tissue from surrounding mucosa in various diseases. Combining high-definition white light endoscopy with CLE significantly increases sensitivity and specificity compared with the sole application of high-definition white light endoscopy. CLE was recently introduced to neurosurgical applications. Although still in an early stage of clinical application, this technique has proven to be capable of...
-
Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma
This is a single-arm, open-label, multicenter study in approximately 52 adults with primary (de novo) GB that has recurred or progressed (first or second recurrence, including this recurrence) after treatment(s) including surgery and radiotherapy with or without chemotherapy and following discontinuation of any previous standard or investigational lines of therapy.
