Scientists at OMRF have developed an experimental treatment for glioblastoma, a deadly form of brain cancer, and beginning this month, the Peggy and Charles Stephenson Cancer Center will be conducting a clinical trial to test the novel therapy in eligible patients who suffer from the disease.
This marks the first time OMRF and the new Stephenson Cancer Center at the University of Oklahoma have collaborated on a Phase I Clinical Trial.
“The new joint project is an exciting example of what we can accomplish when we pool the efforts of experts of great stature who live in Oklahoma,” said OU President David L. Boren.
Glioblastoma is the most common form of primary brain tumor and one of the most aggressive. As the tumors expand, wrapping around critical nerves and blood vessels, they cause a number of symptoms—headache, seizures, nausea, memory loss and more. Eventually, the tumors grow so large they cause massive pressure within the skull or accumulations of water on the brain called edemas. Both can be fatal.
According to the American Cancer Society, an estimated 23,130 people in the United States will be diagnosed with brain and other nervous system cancers in 2013, and more than 14,000 people will die from these forms of cancer. Glioblastoma accounts for about 15 percent of these incidence and mortality statistics. Standard treatment for the illness usually includes surgery to remove as much of the tumor as possible, followed by radiation and chemotherapy to shrink the portions of the tumor that remain.
“Currently, there’s no cure for glioblastoma,” said OMRF scientist Rheal Towner, Ph.D. “Without the usual treatments, patients live about three months after diagnosis. Even with treatment, most live little more than a year.”
Working with fellow OMRF researcher Robert Floyd, Ph.D., Towner developed an experimental treatment for the cancer. In laboratory studies, Floyd and Towner administered the drug, known as OKN-007, to laboratory models with glioblastomas. Tumor size was reduced and lifespan was longer with the treatment.
Using this experimental data, as well as safety data obtained when the compound was previously tested in people who had suffered strokes, OMRF has received approval from the Food and Drug Administration to begin testing OKN-007 in glioblastoma patients.
The clinical trial is designed for glioblastoma patients who have recurring tumors following standard therapies. The initial phase of the trial is focused on assessing the safety and dosage levels of OKN-007. If successful, the trial would progress to subsequent stages to study the efficacy and safety of the investigational drug in larger patient populations.
“The Stephenson Cancer Center is proud to work with OMRF to bring this promising experimental drug to patients with this deadly form of cancer,” said SCC Director Robert Mannel, M.D., “This represents a unique collaboration that unites local innovation and our Phase I Clinical Trials Program. Through participation in this clinical trial, patients can take an active role in fighting their cancer and hopefully improving outcomes for patients everywhere.”
In the past five years, more than 500 cancer patients have participated in early-stage experimental drug trials through the Oklahoma TSET Phase I Program at the Stephenson Cancer Center. The program currently ranks among the top 10 early-stage clinical trials programs nationally for patient enrollment.
“The current treatments for glioblastoma have substantial side effects and complications, and they don’t provide ideal outcomes for patients,” said OMRF President Stephen Prescott, M.D. “There is a desperate need for more effective therapies, and we’re excited to see our investigational drug entering human trials. The ultimate goal is to save lives.”
To find out more about this clinical trial, including the eligibility criteria for participation, please call the Stephenson Cancer Center toll free 1-855-750-CARE (2273)
In addition to the Stephenson Cancer Center, the investigational drug OKN-007 also is being tested in patients receiving treatment at the University of Utah’s Huntsman Cancer Institute.