Randomized Ph.2 Trial for Lerapolturev (PVSRIPO) in rGBM (Recurrent Glioblastoma) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out how safe and effective it is to give people with recurrent glioblastoma two infusions of an experimental drug called lerapolturev (the study drug) in residual disease (within tumor margins) after surgery. After these two doses, we will give further doses of the study drug as injections in the subcutaneous area (under the skin) around the lymph nodes of the head and neck. We also want to know how well the study drug works compared to lomustine, which is a standard form of chemotherapy (drug used to kill cancer cells).
Glioblastoma Multiforme
Who Can Participate in the Study?
Adults ages 18+ who:
- Have a histologically proven recurrent supratentorial glioblastoma or high grade glioma with molecular features of glioblastoma
- Have had prior vaccination series against poliovirus
- Have completed all standard of care treatments, including surgical procedure and radiation therapy
- Do NOT have an impending, life-threatening cerebral herniation syndrome
- Do NOT have lesions in the brainstem, cerebellum, or spinal cord
- Do NOT have evidence of active (growing) disease, or tumor crossing the midline, or leptomeningeal disease
- Do NOT have an active infection requiring intravenous treatment
- Do NOT have known immunosuppressive disease or known human immunodeficiency virus infection
- Do NOT have severe heart disease (New York Heart Association Class 3 or 4)
- Do NOT have a known albumin allergy
- Do NOT have a History of agammaglobulinemia
- Do NOT have known history of hypersensitivity to lomustine
- Do NOT have active autoimmune disease requiring systemic treatment within the past 3 months
For more information about who can be in this study, please contact the study team at 919-684-5301.
What is Involved?
The regimen you will receive if you choose to join this study will depend on when you join. The study team will tell you what stage of the study is enrolling before you decide to join.
If you participate in Stage 1 of the study, you will have a surgical procedure at Duke to place a catheter (thin tube) in the area of remaining/leftover brain tumor after your surgery. The study drug will be given through this catheter. You will get 2 doses about 4 days apart. You will then have weekly visits to the study clinic for 6 weeks.
If you participate in Stage 2 of the study, you will get a random assignment (like drawing numbers from a hat) to 1 of 2 different study arms.
If you are in Arm 1 of Stage 2, you will have a surgical procedure at Duke to place a catheter in the area of remaining/leftover brain tumor after your surgery. The study drug will be given through this catheter. You will get 2 doses about 4 days apart. You will then get subcutaneous (under the skin) injections of the study drug into the area around your cervical lymph nodes (head and neck) nearest to the tumor every week for 4 weeks, and then every 3 weeks for up to a year.
If you are in Arm 2 of Stage 2, you will get the standard treatment for your tumor. You will take an approved drug called lomustine at home for up to 1 year and will return to the clinic every 6 weeks for check-ups.
After you stop taking the study drug or lomustine, we will keep in touch with you to see how you are doing.
If you choose to join the study, you will:
- Have physical exams
- Have blood draws and give urine samples
- Have imaging scans (CT and MRI)
- Have pulmonary function tests (how well your lungs are working) if you are enrolled in Stage 2
Study Details
