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Phase 2 Trial Using Talampanel in Patients With Recurrent High Grade Gliomas
To analyze the effect of Talampanel on progression free survival in patients with recurrent high grade gliomas.
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Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients
The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.
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Phase I/II Bevacizumab Versus Bevacizumab Plus TPI 287 for Recurrent Glioblastoma
The goal of Part I of this clinical research study is to find the highest tolerable dose of TPI 287 that can be given with bevacizumab to patients with glioblastoma. The goal of Part II is to learn if TPI 287 when given with bevacizumab can help to control glioblastoma better than when bevacizumab is given alone. The safety of the drug combination will also be studied. TPI 287 is similar to a type of chemotherapy drug called a taxane and is designed to block a protein (tubulin) that helps the cancer cells divide. By blocking the tubulin, the drug may be able to cause the cancer cells to shrink or stop growing. Bevacizumab is designed to prevent or slow down the growth of...
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Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma
This is a multi-institutional phase III clinical study of interventional type. The trial will include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years of follow up. Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or surgical specimen) and who meet all eligibility criteria will be randomized in one chemoradiotherapy arm : - Conventional arm: 3-dimensional conformational radiotherapy + Temozolomide - Experimental arm : simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide The patient monitoring will be...
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Phase I/II Trial of AXL1717 in the Treatment of Recurrent Malignant Astrocytomas
This is a single-center, open-label, non-randomized, Phase I/IIa study to investigate the safety, tolerability, and antitumor efficacy of AXL1717 (picropodophyllin as active agent formulated in an oral suspension; PPP) in patients with recurrent malignant astrocytomas (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma, and anaplastic ependymoma). Patients will be treated for up to 5 cycles. A treatment cycle is defined as 28 days+7 days rest (28+7 days during cycle 1 to 4, and 28 days during cycle 5). The following cycle will not be started until the treatment continuation criteria are fulfilled. Concomitant supportive...
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Phase I / II Vorinostat, Erlotinib and Temozolomide for Recurrent Glioblastoma Multiforme (GBM)
Phase I Objectives: -To determine the maximum tolerated dose (MTD) of vorinostat + erlotinib versus vorinostat + erlotinib + temozolomide in adult patients with recurrent glioblastoma multiforme (GBM) and anaplastic gliomas. Phase II Objectives: Primary: To determine the efficacy of vorinostat + erlotinib versus vorinostat + erlotinib + temozolomide in patients with recurrent glioblastoma multiforme as progression free survival using a two arm adaptive randomization phase II trial design. Secondary: To determine the radiological response, progression free survival (PFS) at 6 months, overall survival and unexpected toxicity in the two treatment arms; and to...
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Phase II Study of Combined Temozolomide and SGT-53 for Treatment of Recurrent Glioblastoma
This Phase II clinical trial is an open label, single arm, multicenter study of the combination of intravenously administered SGT-53 and oral temozolomide in patients with confirmed glioblastoma who have proven tumor recurrence or progression. The objective of this trial is to assess 6 month progression free survival (PFS), overall survival (OS), anti-tumor activity, safety and possibly to evaluate, nanoparticle delivery to tumor site, and the induction of apoptosis in the tumor..
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Phase II Study of Temozolomide in Newly Diagnosed Glioblastoma
A single arm Phase 2 trial with the study drug temozolomide (temodar) for newly diagnosed glioblastoma in elderly patients (defined as greater than or equal to 70 years old). Following surgical resection, and confirmation of glioblastoma, patients will proceed to primary chemotherapy with temozolomide (temodar). Temodar is given for 42 consecutive days on and 14 days off occurring every 56 days. Procedures prior to initial study treatment (<14 Days) are: Neurological/Oncological History, Neurological Examination, Height, Weight, and Body Surface Area, Performance Status, Quality Of Life FACT-BR, Labs, MGMT tissue analysis, and Cranial CT/MRI with and without contrast. The...
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Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme
In the current proposed trial the role of the low-dose WBRT (0.15 Gy) would be to safely treat the microscopic distant GBM cells outside of the high dose RT region and sensitize the gross tumor, while the focal radiation dose (1.85 Gy) to the gross tumor will bring the total tumor dose of 2 Gy per fraction which is the standard of care. Radiotherapy (RT) has been integral in the treatment of GBM since the 1970s when Walker et al. showed that post-operative whole brain radiotherapy (WBRT) offered significant improvements in median survival time, and even more so when given with concomitant BCNU chemotherapy. Ensuing dose escalation studies found the optimal dose to be 60...
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Phase I Portion of Phase I/II Sorafenib With Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma
The goal of this clinical research study is to find the highest tolerable dose of sorafenib that can be given in combination with temozolomide. The safety of this combination will also be studied.
