The Augusta University Cancer Center, a national leader in immunotherapy research, has opened its first clinical trial for mesothelioma patients.
The phase II trial is open to patients with unresectable peritoneal or pleural mesothelioma, providing a promising new treatment option for this rare and aggressive cancer.
Immunotherapy involves triggering the body’s own immune system to identify and destroy the cancer cells without harming the healthy ones.
This multicenter trial will study the drug tremelimumab, which has shown an ability to stimulate the immune system and attack tumors. It already has shown potential in treating other cancers.
The Augusta Cancer Center, formerly known as the Georgia Regents University Cancer Center, is the only one in the Georgia-South Carolina region.
Mesothelioma is an asbestos-related cancer that can affect the lining surrounding the lungs (pleural), heart (pericardial) or abdominal cavity (peritoneal). Doctors diagnose an estimated 3,000 cases annually in the U.S.
Average life expectancy ranges from nine to 24 months, depending on several factors.
“There just aren’t a lot of options for mesothelioma patients. Those in our state have had to travel quite a distance, north or south, for a trial like this,” cancer center Director Dr. Samir Khleif told Asbestos.com. “We needed to provide something for those patients in our area.”
The cancer center, located in Augusta, Georgia, puts a heavy emphasis on immunotherapy and a multidisciplinary approach to treatment. It has more than 90 ongoing clinical trials in phases I, II, and III.
The center is conducting the first clinical trials that investigate specific immunotherapy treatments that improve survival rates for advanced pancreatic and prostate cancers.
Researchers at Augusta also are involved in drug therapies that target the molecules fueling cancer cell growth. They have clinical trials involving molecular-targeted agents (MTAs) for lymphoma and leukemia.
“There have been a lot of changes in cancer therapy in recent years. There will be a lot more in the future,” Khleif said. “We’re using drugs now that are much more directed at the cancer. Immunotherapy targets the cancer. This is where the field is moving. We [at Augusta] will not only be a big part of that, we’ll be a driving force.”
This first mesothelioma trial at Augusta University Cancer Center began in August and is currently recruiting patients. It also is being conducted at 22 other sites spread across the U.S. and more than 50 sites in 19 other countries.
The Angeles Clinic and Research Institute also is involved in the clinical trial.
Khleif said he hopes to secure at least 20 mesothelioma patients at Augusta for the study. The trial is a randomized, double-blind, parallel-group study: For every two patients getting tremelimumab, one will be receiving only a placebo, and neither the patients, nor attending physicians, will know who is receiving the actual drug.
Patients interested in this clinical must have received one or two lines of systemic chemotherapy that included a pemetrexed-based regimen previously.
The study will include a screening period, treatment period, early follow-up period to help determine safety of the drug, and a long-term survival follow-up period. Researchers will measure the time from initial randomization until disease progression and eventual death.
Both the tremelimumab and the placebo will be administered as an IV solution. Patients will receive one dose every four weeks. After the sixth dose, they will receive it once every 12 weeks until the disease shows progression. Imaging assessments will be obtained every three months.
The hope with tremelimumab is that it can unmask the mesothelioma cells. A person’s immune system normally destroys cells that are recognized as foreign. That is how a person fights off a virus. But because a person is producing the cancer cells, they are not immediately recognized as foreign.
Tremelimumab has been used in earlier studies with mixed results on melanoma, prostate and bladder cancers.
“Clinical trials with immunotherapy drugs have gone better than expected, more surprisingly positive than we expected,” Khleif said. “It’s why everyone is excited now about immunotherapy.”