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Glioblastoma clinical trials

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NCT ID: NCT01822275 Terminated - Clinical trials for Histologically Proven Diagnosis of Glioblastoma or Gliosarcoma (WHO Grade IV)

Phase II Trial of Low-Dose Whole Brain Radiotherapy With Concurrent Temozolomide and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma Multiforme

GCC 1224
Start date: May 2013
Phase: Phase 2
Study type: Interventional

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 Gy. Patients could not tolerate escalation to higher doses than 60 Gy with WBRT due to unacceptable toxicity. Even with WBRT of 60 Gy, a huge volume of healthy brain tissue was unnecessarily treated with high-dose radiation; recurrences with WBRT remained overwhelmingly local. Hochberg and Pruitt (1980) found that after WBRT only 3% of recurrences were outside 2 cm of the margins of the primary tumor. With the rise of the CT scan in the 1980s and the MRI in the 1990s, along with subsequent improvements in three-dimensional conformal radiation, partial brain RT (PBRT) became practical since tumor margins could be visualized and irradiated more accurately. - Subsequently, WBRT was shown to provide no survival benefit over PBRT at the same dosage; - thus, the latter took over as the standard of care.

NCT ID: NCT01814813 Terminated - Clinical trials for Recurrent Glioblastoma

Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

Start date: May 2013
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab works in treating patients with recurrent glioblastoma multiforme that can be removed by surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person's own tumor tissue may help the body build an effective immune response to kill tumor cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. It is not yet known whether giving vaccine therapy is more effective with or without bevacizumab in treating glioblastoma multiforme.

NCT ID: NCT01778530 Terminated - Clinical trials for Glioblastoma Multiforme

TRC105 for Recurrent Glioblastoma

Start date: December 2012
Phase: Phase 2
Study type: Interventional

Background: - Glioblastoma is an aggressive type of brain cancer that often resists treatment. TRC105 is an experimental drug that blocks the growth of new blood vessels. It is being studied for possible use in treating different kinds of cancer. Researchers want to see if TRC105 can be used to treat glioblastoma that has not responded to standard treatments. Objectives: - To test the safety and effectiveness of TRC105 in adults who have glioblastoma that has not responded to standard treatments. Eligibility: - Individuals at least 18 years of age who have glioblastoma that has not responded to standard treatments. Design: - Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies and other tests will be used to study the tumor before the start of treatment. - Participants will have 28-day (4-week) cycles of treatment. - Participants will have TRC105 intravenously once a week. The first infusion will take about 4 hours. The length of time needed for the infusion may be slowly reduced if it is well tolerated. - At the end of the first cycle (the first 4 weeks), the imaging studies will be repeated before continuing TRC105. - Participants will take TRC105 for as long as the tumor does not grow and the side effects are not too severe. They will have imaging studies at the end of every cycle to evaluate the tumor.

NCT ID: NCT01756729 Terminated - Clinical trials for Recurrent Glioblastoma Multiforme

Post-approval Study of NovoTTF-100A in Recurrent GBM Patients

Start date: December 2012
Phase: Phase 4
Study type: Interventional

This is a non-randomized, concurrent control study, designed to confirm that the efficacy of the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings following approval is comparable to that of BSC chemotherapy patients. The device is a portable, battery operated device that was approved for the treatment of adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.

NCT ID: NCT01721577 Terminated - Glioblastoma Clinical Trials

Phase I/II Trial of AXL1717 in the Treatment of Recurrent Malignant Astrocytomas

AXL1717
Start date: December 2012
Phase: Phase 1/Phase 2
Study type: Interventional

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 therapies will be allowed.

NCT ID: NCT01702792 Terminated - Glioblastoma Clinical Trials

Derivation of Tumor Specific Hybridomas

Start date: January 2014
Phase: Phase 1
Study type: Interventional

This is a non-randomized, open-label study in patients with newly diagnosed glioblastoma to determine the ability to generate human hybridomas from lymph nodes draining an autologous tumor vaccine injection and demonstrate that the hybridomas secrete glioblastoma-specific antibodies.

NCT ID: NCT01700569 Terminated - Glioblastoma Clinical Trials

Phase-1 Study of Folinic Acid to Modulate MGMT Gene in Glioblastoma

FOLAGLI
Start date: January 2013
Phase: Phase 1
Study type: Interventional

O6-méthylguanine méthyltransférase (MGMT) is the main repair gene after DNA lesion induced by Temozolomide in combination with radiation therapy of Glioblastoma (GBM) in Stupp.R et al published regimen. In preclinical models, it has been demonstrated that MGMT methylation (which is silencing the DNA repair process) is achievable by folic acid. About half of the patients with operated GBM have an un-methylated MGMT gene status and therefore a poorer prognosis. A phase-1 dose escalation study is proposed with pharmacologic doses of folinic acid in combination with temozolomide and radiotherapy of operated GBM.

NCT ID: NCT01666600 Terminated - Clinical trials for Glioblastoma Multiforme

NOA-12: BIBF1120 and R-RT in Glioblastoma

Start date: August 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. In the phase I part the minimal tolerated dose (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.

NCT ID: NCT01587144 Terminated - Clinical trials for Glioblastoma Multiforme

Safety and Efficacy Study of Lucanthone When Used in Combination With Temozolomide(TMZ) and Radiation to Treat Glioblastoma Multiforme(GBM)

Start date: June 19, 2012
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine the effectiveness of an investigational drug called lucanthone, when combined with temozolomide (TMZ) and radiation in the treatment of Glioblastoma Multiforme (GBM).

NCT ID: NCT01582152 Terminated - Brain Neoplasms Clinical Trials

Phase I/II Bevacizumab Versus Bevacizumab Plus TPI 287 for Recurrent Glioblastoma

Start date: July 2012
Phase: Phase 1/Phase 2
Study type: Interventional

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 cancer cells by blocking the growth of blood vessels.