Moffitt Cancer Center in Tampa has joined the National Cancer Institute in Bethesda, MD for a new mesothelioma clinical trial involving CRS-207, a promising immunotherapy vaccine.
Moffitt’s involvement is part of its latest push to take more of a leadership role and step up its efforts in the fight against mesothelioma, the cancer caused by asbestos exposure.
Although Moffitt has been treating mesothelioma patients successfully for many years, it recently revamped its efforts and raised its visibility with the new Mesothelioma Research and Treatment Center.
“We’re putting more of an emphasis on clinical and translational research here,” said medical oncologist Scott Antonia, M.D., chairman of the Thoracic Oncology Department at Moffitt. “The principal motivation is to develop new and better therapies for this disease.”
Antonia is particularly enthused about the Phase IB mesothelioma trial that includes patients receiving two prime vaccinations of CRS-207, along with standard chemotherapy (cisplatin and pemetrexed), and at least two booster vaccinations.
The first patient in the two-site trial was enrolled earlier this month. The trial is aimed only at patients newly diagnosed with malignant pleural mesothelioma. Moffitt also is making plans to move forward with two more Phase I clinical trials for mesothelioma, both under the immunotherapy umbrella.
“We (oncologists everywhere) are stuck at a plateau with what we can accomplish with chemotherapy,” Antonia said. “What is available to mesothelioma patients today is not curing people. More research is critical.”
CRS-207, a product of California-based Aduro BioTech, Inc., is a vaccine designed to boost a patient’s immune system by targeting mesothelin, which is overly expressed in mesothelioma cells. While the standard chemotherapy regime helps kill the cancer cells, the CRS-207 is expected to help a patient’s healthy cells fight off any new cancer growth.
The vaccine comes from genetically-modified bacteria that is engineered to induce an immune response within certain tumor types, including pancreatic, ovarian and mesothelioma cancers.
According to Aduro BioTech, an earlier Phase I trial with end-stage cancer of various types in 17 participants showed promising results. Although the expected survival time was just three to five months, six of the 17 patients who were part of the trial lived 15 months or longer.
The results led to a Phase 2 clinical trial involving pancreatic cancer patients and the Phase IB trial for mesothelioma now proceeding jointly at Moffitt and the National Cancer Institute (NCI).
Aduro’s theory is that this bacteria, after being modified, can strengthen the immune system enough to fight off various cancers. There are numerous other clinical trials ongoing that involve immunotherapy responses. There are many scientists today who believe that a body’s own immune system, if strengthened enough, is the key to stopping cancer.
This trial is designed to determine when used in conjunction with chemotherapy the safety of the vaccine, whether it has any effect on tumors, and if it can stimulate the immune system and target cancer cells.
Moffitt also has been working on a Phase III clinical trial for mesothelioma that involves NGR-TNF, an engineered combination protein that binds to cells providing blood supply to cancer cells and effectively kills them without harming the healthy ones.
“What we have now (for mesothelioma) is not good enough,” Antonia said. “We have to do better. And that starts with clinical trials. You always hope this could be the one. Sometimes there is a negative connotation (surrounding a clinical trial), but every treatment out there today is a result of someone who participated in a clinical trial.”