Houston Methodist participated in an international Phase III clinical trial of a cancer vaccine that extended median survival in newly diagnosed and recurrent glioblastoma brain cancer patients.


The trial results were reported today in the cancer journal JAMA Oncology, and co-authored by neurosurgeon David Baskin, M.D., director of the Kenneth R. Peak Brain & Pituitary Treatment Center in Houston Methodist’s Department of Neurosurgery. It is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma.


The vaccine is made from a patient’s own immune cells (dendritic cells) and antigens from a sample of the patient’s own tumor and was administered by injection in the upper arm, with six treatments in the first year, and two treatments per year for maintenance after that first year.


In the Phase III trial of the DCVax®-L, the newly diagnosed patients treated with the vaccine survived for a median of 22.4 months from surgery, and five-year survival was 13%.  The subgroup of such newly diagnosed patients who had methylated MGMT gene (about 40% of the patients) had median survival of 33 months from surgery.


The recurrent glioblastoma patients treated with the vaccine survived for a median of 13.2 months from recurrence; 20.7% of the patients survived for 24 months after recurrence and 11% of the patients survived for 30 months.


Standard of care (SOC) treatments for glioblastoma – among the most common and lethal forms of brain cancer – have remained virtually unchanged for nearly two decades.  Patients typically survive for only 15 to 17 months from diagnosis, with the tumor recurring at about six to eight months from diagnosis. Patients generally survive for about seven to nine months after recurrence.  Five-year survival from diagnosis is only about 5%.


“Glioblastoma is among the most aggressive and worst types of brain cancer, and so many diverse treatments have failed in clinical trials,” Baskin said  “We have many ongoing glioblastoma trials at  Houston Methodist’s Peak Center, and seeing the results of this particular trial may offer a viable option for glioblastoma patients worldwide.”


The treatment was well tolerated. Out of 2,151 doses administered in the trial, five serious adverse events were reported that were considered “possibly related” to the treatment, and included three cases of intracranial edema, one case of nausea and one case of lymph node infection. The adverse reactions did not occur at Houston Methodist.