Detroit-based Henry Ford Cancer Institute is the first in the world to enroll a patient in the GBM Adaptive Global Innovative Learning Environment (AGILE) Trial, which is aimed at identifying the most effective therapies for patients with glioblastoma, the most aggressive form of brain cancer.
The trial design and architecture are made possible by an international collaboration of experts who care for patients with glioblastoma and design clinical trials. The trial sponsor is the Global Coalition for Adaptive Research.
A next-generation clinical trial program and the first-ever adaptive platform trial for brain cancer, GBM AGILE is a move away from the traditional one-size-fits-all approach to clinical trials and therefore a step forward for precision medicine.
“We are launching an era of unprecedented collaboration and advancement in glioblastoma treatment,” says Dr. Steven Kalkanis, chairman of the Department of Neurosurgery at Henry Ford Health System and medical director of the Henry Ford Cancer Institute. “Current treatments have been refined – including surgery, radiation and chemotherapy – but in the era of molecular medicine, dramatic leaps in outcomes through immunotherapy or targeted therapies are yet to be fully realized. With GBM AGILE, those dramatic leaps in outcomes will be more attainable, and at a faster pace, than ever before.”
Traditional clinical trials take 3-7 years to produce results, cannot be modified once started, and study only one treatment against the standard of care. GBM AGILE is designed as a long-standing platform with the ability to test multiple therapies concurrently against the standard of care, allowing more patients in the trial access to experimental therapies.
GBM AGILE is also innovative because it uses adaptive randomization, which means it is continuously updated with the latest information. As information builds, the trial defines subsets of patients more likely to benefit from therapy. Patients are more likely to receive promising therapies at a faster and less costly rate.
“Progress in the treatment of patients with malignant brain tumors has been slow,” says Dr. Tom Mikkelsen of the Henry Ford Cancer Institute and medical director of the Precision Medicine Program and Clinical Trials Office at Henry Ford Health System. “The efficiency, speed and learning of GBM AGILE is intended to allow rapid discovery of better and better treatments for patients with glioblastoma. The era of data-driven innovation has arrived, and it’s being applied to the most difficult problems in cancer therapy.”
The trial was first conceived in 2015 by an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, patient advocates, and government and industry leaders. It came together in response to a worldwide effort known as The Cancer Genome Atlas, which was launched in 2006 by the National Cancer Institute and the National Human Genome Research Institute and performed a 10-year study into the molecular basis of certain kinds of cancers.
One of the first types of tumors studied in the effort was glioblastoma. Henry Ford was a major contributor to the effort, and nearly 25 percent of all the gliomas studied over the course of the 10-year initiative were donated by Henry Ford’s Hermelin Brain Tumor Center.
“This is an important milestone for GBM AGILE and all those involved in this effort, most importantly the patients, who desperately need new treatment options,” says Dr. Meredith Buxton, COO of the Global Coalition for Adaptive Research. “We value the dedication of Dr. Tom Mikkelsen and the team at Henry Ford Cancer Institute to make this trial available to their patients and are eager to continue to work with our other committed study sites and investigators to make this trial available to patients across the United States this year and internationally in 2020.”
Former Vice President Joe Biden has been a supporter of GBM AGILE and attended the launch event in November 2015. Biden’s son, Beau Biden, died from glioblastoma in May 2015 at the age of 46. He had been diagnosed in 2013 and was treated with surgery, chemotherapy, and radiation. He suffered a recurrence in the spring of 2015.
Gliobastoma is one of the deadliest diseases on the planet. When treated with surgery, radiation, and chemotherapy, patients have a median life expectancy of 11-15 months. The disease most commonly affects men ages 60 and older, but it can develop at any age in men and women. The National Cancer Institute estimates that 22,850 adults were diagnosed with brain and other nervous system cancers in 2015. It also estimates that in the same year, more than 15,000 of those diagnoses resulted in death.
The Henry Ford Cancer Institute offers care at five hospitals, six outpatient facilities, and dozens of aligned doctors’ offices throughout southeast and southcentral Michigan. Treatment for the most complex or rare cancers and the institute’s cancer research program is anchored by the Henry Ford Hospital in Detroit.