Seeking Adults with Newly Diagnosed Glioblastoma


16918

A Prospective, Multicenter Trial of Novo TTF-100A Together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM

Neurology

Schiff David,

UVA Health System seeks men and women 18 years and older, with newly diagnosed glioblastoma (GBM) brain cancer following surgery, to participate in a clinical research study. The purpose of this study is to evaluate if adding an investigational device (NovoTTF-100A) slows tumor growth and improves overall survival versus standard-of-care treatment only in patients with newly diagnosed GBM. The study will also measure the safety of this device. The NovoTTF-100A delivers low energy, alternating electric fields to the tumor site through the scalp by means of electrodes (pads connects to wires) attached to your head. These fields are known as Tumor Treating Fields of TTFields and they are hoped to slow or reverse tumor growth. You must have your head shaved to wear the device. Standard-of-care treatment for GBM typically combines surgery, radiation therapy, and chemotherapy. Radiation therapy is in the form of external beam radiation administered for approximately 6 weeks. Temozolomide (Temodar), an oral medication, is the standard chemotherapy drug used, and is taken at the same time as radiation therapy. NovoTTF-100A is an investigational agent in this study – it is not yet FDA-approved for treatment of newly diagnosed GBM. The device is approved by the FDA for treatment of certain recurrent GBM tumors. Patients with recently diagnosed GBM who have undergone surgical resection of the tumor and have planned radiation and Temodar treatment are eligible to undergo trial screening procedures. Patients who meet eligibility criteria, complete the screening process, and are enrolled into the study will be randomized to receive either Temodar alone or Temodar plus NovoTFF-100A. You will have a 50% chance of undergoing treatment with the investigational device. Temodar is administered on 28 day cycles (which oral drug being taken the first 5 days of each cycle). Patients randomly assigned to the NovoTTF-100A group will wear the device continually through the length of Temodar treatment (and after if recommended by your doctor). Treatment with the device may be discontinued if you experience unacceptable side effects or if you or your doctor so choose. Participants in this study will have routine neurological and physical exams performed as well as tumor evaluations done by MRI. Blood samples will be collected for routine, or standard of care, testing. You will not receive any payment for participating in this study. For more information, or to see if you qualify to take part in this study, please contact: Contact: Monika Thielen Phone: (434)-243-9900 Email: mjt3c@virginia.edu Primary Investigator: David Schiff, MD IRB-HSR# 16918


Adult

Brain Cancer
Glioblastoma

Neurosurgery
Neurology
Neuro-Oncology
Cancer (Oncology)

Ill

No Compensation

Monica Thielen

mjt3c@virginia.edu

4342439900