Brain Tumor Program Clinical Trials

Newly diagnosed high grade glioma

A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme (GBM) (04/02/2012 - present) In this study, patients with newly diagnosed glioblastoma undergo surgery and a portion of the tumor is sent to a laboratory to synthesize a virus that is given together with standard treatments to direct the immune system in targeting tumor cells.

A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM (07/03/2012-present) A trial for patients with newly diagnosed brain tumors that involves the use of alternating magnetic fields emitted by a helmet-like device worn by the patient. These fields have been shown to disrupt the mechanism by which cells divide in a process called 'mitosis'.

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma (01/30/2012 - present) This study involves the administration of an antibody to a protein found in approximately 30% of tumors in patients with newly diagnosed high grade glioma. (Immunotherapy or vaccines for brain tumors)

Clinical trial for recurrent high grade glioma

A Phase II Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma (07/18/2013 - present) This is a similar study as above but offered to patients with recurrent high grade glioma (Immunotherapy or vaccines for brain tumors)

A Phase 1 Ascending Dose Trial of the Safety and Tolerability of Toca 511 in Patients With Recurrent High Grade Glioma (10/21/2013 - present) This study was designed to address one of the challenges in using chemotherapy to treat brain tumors. Namely, that the blood vessels of the brain are not permeable to most large chemotherapy molecules. Some medications that have the capacity to inactivate brain tumor cells in a petri dish or 'in vitro' are ineffective because of this 'blood brain barrier'. 5-FU is an example of a drug that is limited because of this barrier although it is used commonly in other systemic cancers.

This study involves two distinct steps to surmount this issue. In the first, a surgery is performed to precisely place a delivery catheter into a tumor using real-time MR imaging together with computer or 'stereotactic' guidance. This catheter is designed to deliver a virus that has been genetically modified to selectively infect tumor cells and to express a gene called cytosine deaminase. This gene allows for the conversion of 5-FC-an orally administered medication that readily crosses the blood brain barrier-into 5-FU the chemotherapy medication mentioned above. After surgery, virus is given several weeks to infect tumor cells at which point the patient begins taking 5-FC. (Gene Therapy for Brain Tumors)

Phase 2 Dose-Escalation Study of TPI 287 in Combination With Bevacizumab in Adults With Recurrent Glioblastoma (06/10/2013 - present) This study is open to patients with recurrent tumor and involves the use of a newly developed formulation of an established chemotherapy called Taxane. The innovation in this case is that this preparation of Taxane is able to cross the blood brain barrier.

A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96) (NSC # 725085, ALLIANCE IND # 15380) Vaccine Given With Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM) (10/22/2013 - present) In this study patients with recurrent glioma undergo surgery for resection and a portion of the tumor is sent for the synthesis of an antibody targeting a different protein found in tumor cells called, 'Heat Shock Protein'. The antibody is administered together with another medication-Avastin (Bevacizumab)-to empower the immune system to fight the tumor. (Immunotherapy or vaccines for brain tumors)

TOCAGEN TRIAL