Dr. Jon Olson
First came the vaccine for Human Papillomaviruses (HPVs), which can lead to cervical cancer as well as head and neck cancer. Now underway are trials for brain, breast and pancreatic cancer vaccines. Ongoing studies at The Cancer Program of Our Lady of the Lake Mary Bird Perkins Cancer Center and the Neuromedical Center in Baton Rouge will determine if these vaccines could help treat or stop recurrence of certain types of these tumors.
For more information about the clinical trials, contact The Cancer Program of Our Lady of the Lake and Mary Bird Perkins Clinical Trials Department: (225) 215-1353 or visit email@example.com
The brain study, ACT IV, is for patients with newly-diagnosed glioblastoma multiforme that contains Epidermal Growth Factor Receptor (EGFR) vIII. About 30 percent of glioblastomas have an EGFR. ACT IV uses the vaccine rindopepimut to target EGFRvIII, believed to play a role in tumor cell growth. “The vaccine is designed to train your immune system to recognize this specific growth factor receptor and fight it off,” explained Dr. Jon Olson, a neurologist specializing in neuro-oncology and principal investigator of the brain study. “One of the things that we think growth factor receptors do is drive the tumor. And so, if you can get rid of that drive, then your time to recurrence and how long you can survive with the tumor, should, at least in theory, be better. Phase I and Phase II studies look promising enough to go into this Phase III study.”
This study is international in scope, with several sites in the United States and Europe and Asia. The Cancer Program in Baton Rouge is the only location in Louisiana to participate in the brain study.
The brain study consists of two portions. First is screening the patient’s tumor specimen for eligibility. Second is the patient’s informed consent to the vaccine after they are confirmed eligible and understand all that is involved with this new treatment. “Most of the time we will send their tumor soon after surgery,” Olson said. “If patients are finishing initial radiation and chemo treatment and need a ‘rush’ to screen their tumor by the time they finish treatment, that can be done also.”
Within the last two months, Olson’s team has screened two patients for the brain vaccine. One of the patients was positive for EGFRvIII. “She was ready to sign up immediately,” Olson reported. “The treatment is an easy sell from my standpoint because it is promising and looks to be very safe.”
Standard treatment for glioblastoma involves radiation plus oral chemotherapy (temozolomide). The new treatment regimen adds injections of rindopepimut/GM-CSF (Leukine®, sargramostim). Patients will randomly receive a placebo injection (KLH control plus temozolomide) or the vaccine. The vaccine will be repeated once a month until the tumor recurs or the patient opts out.
The Phase III study will continue enrolling for about two years. Next is approval by the FDA. “The safety of the vaccine looks very encouraging,” Olson reported.
Preliminary studies look promising. “It looks like patients’ survival was increased compared to what we normally see,” he said. “And, it appears that the vaccine really does take care of the EGFRvIII in some of the patients who have had a second surgery for when that tumor does recur and it is no longer present.”
However, Olson cautions that this does not mean the vaccine will cure brain tumors. “I don’t know whether I would expect this to be a cure, because this tumor is notoriously smart in figuring out ways around some of the things that we throw at it. It finds alternate pathways to resistance to chemotherapy or getting rid of receptors. And that’s one of the big frustrations with treating glioblastoma, is that it looks like there’s some good options for treating a tumor in a test tube or in a lab, but when you apply it to a real human being, there are just too many alternate paths where it can start to regrow. But, at least the hope is that we will see significant improvements in their time to recurrence and overall survival. It may not be that patients are cured, but hopefully they will live better quality of lives and longer periods of time with this.”
The breast cancer vaccine study is led by investigator medical oncologist Derrick Spell. This study’s purpose is to evaluate the safety and effectiveness of the investigational drug NeuVax. The vaccine is designed to prevent the recurrence of node-positive, early stage breast cancer with low to intermediate HER2 expression. The Baton Rouge center has five to six patients enrolled in the trial. “I am optimistic that the science behind it is very solid,” Spell said. “The whole question is whether or not this drug will work or not.”
Investigator Bryan Bienvenu heads up the pancreatic cancer study. This study compares the effects of standard of care therapy (gemcitabine alone or with chemoradiation) with or without the addition of HyperAcute Pancreas Immunotherapy to determine which treatment is more effective.