Saint John’s Health Center Foundation April 9 announced that PHASE ONE Foundation has provided the initial funding for a breakthrough clinical trial for patients with brain cancer.
Indian American physician Dr. Santosh Kesari, the trial’s principal investigator and author, will conduct the study at Pacific Neuroscience Institute, John Wayne Cancer Institute and Providence Saint John’s Health Center, the foundation said in a news release.
“Glioblastoma is an insidious disease,” Kesari, director of neuro-oncology at Pacific Neuroscience Institute and chair of neurosciences and neurotherapeutics at John Wayne Cancer Institute, said in a statement.
“This is an aggressive and lethal form of brain cancer that carries a very poor prognosis of 14-16 months survival. The tumor generally has a main mass that can be surgically debulked in many cases. However, in this cancer type, additional tumor cells extensively invade normal brain tissue and cannot be surgically removed without causing damage.”
The Kesari-led study, Precision Immunotherapy in the Neoadjuvant Setting, provides an alternative immunotherapy option to the current standard of care treatment that patients receive when presenting with a new diagnosis of glioblastoma, according to the news release.
This new clinical trial approaches glioblastoma treatment in a whole new way. By giving immunotherapy first rather than radiation and chemotherapy, the patient's immune system remains uncompromised which could result in better responses and lead to better patient outcomes, it said.
Over the last 30 years, the standard of care for newly diagnosed glioblastoma patients has involved surgical removal of the tumor where possible followed by radiation and chemotherapy, the foundation explained.
While this therapy regimen has afforded limited survival benefit, there is much room for improvement. Expert neurosurgeons Drs. Daniel F. Kelly and Achal Singh Achrol work closely with Kesari to care for these very sick patients, it said.
The PIN protocol uses immune therapies for difficult-to-treat patients whose immune systems have not yet been compromised by standard radiation and chemotherapy. PHASE ONE Foundation’s investment of $300,000 has allowed the PIN trial to open immediately and begin recruiting patients for the initial phase 1 safety trial, the news release said.
The three-armed trial will compare standard of care with two immunotherapy drugs that target different immune checkpoint inhibitor pathways to disrupt cancer cell proliferation. Biospecimens including blood and CSF will be collected and analyzed over the course of patient treatment, providing valuable insights into anti-tumor activities of the study drugs and biomarker characteristics of responders, it said.
Current research indicates that temporarily delaying use of standard treatment has little negative effect on overall survival. Patients in the two immunotherapy arms will be monitored for therapeutic efficacy and safety and can remain on study treatment as long as they are benefiting. Standard care is always available if needed, it added.
“We are hopeful about this approach which represents a real paradigm shift in the treatment of newly diagnosed glioblastoma patients,” said Kesari.
“The standard treatments using radiation and chemotherapy diminish the patient’s immune system,” he added. “The benefit of treating the patient before standard therapy should in theory allow the patient to respond to immunotherapy more strongly and fight the cancer more effectively.”
The foundation noted that, while PHASE ONE Foundation’s support is vital in getting the clinical trial off the ground, more funding is necessary to expand and develop the program.