Newly Diagnosed Glioblastoma

An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

WHO: Newly diagnosed, de novo glioblastoma patients including, small cell glioblastoma, giant cell glioblastoma, gliosarcoma and glioblastoma with oligodendroglial component

WHY: To find out whether adding the investigational drug rindopepimut (also known as CDX-110) to the commonly used chemotherapy drug temozolomide helps shrink or prevents brain tumors from growing and helps patients with brain tumors live longer than treatment with temozolomide alone

SPONSOR: Celldex Therapeutics


A Phase II Clinical Trial Evaluating DCVax®-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme (GBM)

WHO: Patients with newly diagnosed, unilateral GBM (Grade IV)

WHY:  To determine whether DCVax-Brain can slow the growth and recurrence of brain tumors and extend overall survival

SPONSOR: Northwest Biotherapeutics


A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM

WHO: Newly diagnosed patients with glioblastoma multiforme (brain tumor).

WHY: To compare treatment using a new experimental device, the NovoTTF-100A, with maintenance Temozolomide compared to maintenance Temozolomide alone

SPONSOR: Novocure  


Recurrent Glioblastoma 

A Phase 1/2, Multi-Center, Open-Label, Dose Finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the mTOR Kinase Inhibitor CC-223 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin Lymphoma or Multiple Myeloma

WHO: Patients with advanced solid tumor, Non-Hodgkin Lymphoma or multiple myeloma  who have not tolerated or progressed on standard therapy and no further standard therapy is available

WHY: To test the safety of a new experimental drug called CC-223, an mTOR inhibitor

SPONSOR: Celegene Corporation


Chemotherapy Induced Neuropathy

A Randomized, Double-Blind, Dose-Finding, Placebo-Controlled, Phase II Multi-Center Study of Tetrodotoxin in the Treatment of Chemotherapy Induced Neuropathic Pain

WHO: Patients with moderate to severe neuropathic pain caused by chemotherapy who have completed chemotherapy and have no immediate plans to resume chemotherapy

WHY: To determine the safety and efficacy of subcutaneous Tetrodotoxin treatment in reducing and treating chemotherapy induced neuropathic pain and improving the quality of life

SPONSOR: WEX Pharmaceuticals, Inc


Primary and Metastatic Brain Tumors

Use of Visualase Thermal Therapy System for MRI Guided Laser-Induced Thermal Therapy (LITT) in Brain Tumors

WHO: Patients with high-grade gliomas, metastatic brain tumors, and other brain tumors deemed appropriate for ablation by the treating surgeon

WHAT: To see if the FDA-approved device Visualase Thermal Therapy System can be used to treat people with brain tumors. The Visualase Thermal Therapy System uses lasers to generate heat that can destroy tissue, including brain tumor cells

SPONSOR: Visualase Inc.


Members of the Cancer Trials Support Unit (CTSU), an NCI-sponsored network which includes the American College of Surgeons Oncology Group (ACOSOG), Cancer and Leukemia Group B (CALGB), and North Central Cancer Treatment Group (NCCTG) 


For more information about our Neuro-Oncology clinical trials, please call 551-996-5266.


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