The purpose of this study is to see how safe the investigational study drug is - either IGV-001 (study drug) plus standard of care (SOC) or placebo plus SOC - and to see if it works in slowing GBM tumor regrowth. SOC treatment for this study refers to temozolomide and radiotherapy used to treat your cancer.
At each visit, you will meet with a member of the study team and fill out questionnaires. The study involves blood collection for research purposes in addition to routine blood work, you will have an electrocardiogram (ECG), and magnetic resonance imaging (MRI) scan to confirm the cancer status in your body. During screening you will also have surgery to remove your brain tumor (called a craniotomy and tumor resection to confirm your diagnosis is malignant glioma, perform gene testing and to make the study immunotherapy (IGV-001). For treatment you will have a surgical procedure where the study doctor will insert the biodiffusion chambers into your belly area, which will be removed by a surgical procedure on day 3. After the biodiffusion chamber has been removed you will be prescribed a steroid medicine. Around week seven you will begin the standard of care (SOC) treatment period, the SOC will be a combination of radiation therapy (also called radiotherapy) and temozolomide. During this period, you will need to come to the study clinic 5 days per week for 6 weeks to receive your radiotherapy while taking temozolomide daily. About 4 weeks after your last treatment of radiotherapy, you will begin taking temozolomide on Days 1 through 5 of 28-day cycles, for a total of 6 cycles (or about 24 weeks). During the SOC Treatment Period, you will also need to visit the study clinic once per month.
Study Medication, $50 VISA pre-paid debit card for you to use for incidentals during study visits
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Soma Sengupta
LCCC - Clinical Trials
Clinical or Medical
Interventional
Cancer (Brain and Other Nervous System)
23-1597