A vaccine for people newly diagnosed with glioblastoma multiforme (GBM)—the most aggressive and highest-grade malignant glioma—is now being tested at 20 sites nationwide in a randomized, placebo-controlled, phase II clinical trial. The study is designed to evaluate progression-free survival associated with the vaccine as well as the vaccine’s safety and tolerability in men and women 18 to 80 years who have not yet received chemoradiation for GBM.
All study enrollees will undergo surgery followed by radiation and chemotherapy, which constitute the current standard treatment for GBM. After radiation, two-thirds of the participants will receive the experimental vaccine, whereas the others will receive a placebo vaccine.
ImmunocellularTherapeutics, Ltd., is conducting the trial. According to the biotechnology company, the 16 patients involved in the small, open-label phase I portion of the study demonstrated a 1-year overall survival rate of 100% and a 2-year survival rate of 80%. Historical data for standard care alone show a 1-year survival rate of 61% and a 2-year survival rate of 26%.
Whereas other treatment approaches mostly target differentiated tumor cells, the ICT-107 vaccine targets the antigens that are present on glioma stem cells. “If the stem cells aren’t targeted, they keep generating more tumors,” explained Glenn Lesser, MD, in a statement issued by Wake Forest Baptist Medical Center, where Lesser is a professor of hematology-oncology as well as the principal investigator for that study site.
ImmunoCellular Therapeutics is currently recruiting participants for the phase II trial. For more information, contact Philip Dehazya, PhD, via telephone (914-733-3445) or e-mail ([email protected]), or see the study description and a list of participating sites and principal investigators at ClinicalTrials.gov (identifier: NCT01280552; http://clinicaltrials.gov/ct2/show/NCT01280552).