The David S. Zocchi Brain Tumor Center at Monmouth Medical Center is a research site for the ACT IV study – an international clinical trial evaluating the effects of adding an investigational vaccine to standard treatment in patients with glioblastoma, the most commonly diagnosed cancerous brain tumor.
Approximately one-third of patients with glioblastoma express a particular genetic mutation – the Epidermal Growth Factor Receptor protein variant III (EGFRvIII) – which is linked to increased tumor cell growth. Rindopepimut is an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express this EGFRvIII protein.
Sumul N. Raval, M.D., is the medical director of the Brain Tumor Center and primary investigator for the study at Monmouth Medical Center. “The ACT IV study, evaluates the survival rate, time to disease progression, and quality of life among patients with this genetic mutation (EGFRvIII) when the investigational vaccine rindopepimut is added to standard chemotherapy treatment ” said Dr. Raval.
The study is open to adults with newly diagnosed EGFRvIII-positive glioblastoma. Potential participants will undergo a screening phase, during which tumor tissue is tested for EGFRvIII. Other tests, including brain MRIs, physicals, blood tests, among others, will also be performed to determine eligibility.
Once a patient is accepted into the study, he or she will undergo one of two treatment regimens – both of which include injections of the standard course of chemotherapy treatment, temozolomide. One regimen will add injections of rindopepimut – the vaccine under evaluation – combined with a low dose of GM-CSF to “activate” the immune system. The other regimen will add injections of Keyhole Limpet Hemocyanin – the control injection. Study participants have an equal chance of receiving either treatment regimen, and neither the patient nor the doctor will know which treatment the patient is receiving.
During treatment, patients will be closely monitored and will be asked to visit the clinic site several times per month for standard medical tests, including blood tests and periodic brain imaging. Participants will be contacted every month to evaluate their health and to see what additional treatments are being used to treat their glioblastoma.
Participation in the ACT IV study is voluntary and may last up to five years or longer. Patients should discuss the study and other possible treatment options with their doctor, family and friends before deciding to participate. Taking part in the study may or may not improve the condition of a patient’s glioblastoma. There may be risks associated with study participation, and patients should discuss these risks with the study doctor.
To learn more about the clinical trial, visit www.GlioblastomaStudy.com. For more information on the David S. Zocchi Brain Tumor Center at Monmouth Medical Center, call 1-877-577-9800.