The Angeles Clinic and Research Institute, which carved an international reputation for developing personalized cancer therapies, is opening its first mesothelioma-specific clinical trial.
The Institute in Santa Monica, Calif., will be part of a multi-center, Phase 2 study of tremelimumab, an immunotherapy agent that has shown success treating other cancers.
The trial is open to patients with unresectable pleural or peritoneal malignant mesothelioma. To be included, patients already should have received either one or two lines of systemic chemotherapy that included a pemetrexed-based regimen.
“I’m a big proponent of immunotherapy,” said Ani Balmanoukian, M.D., director of the Lung Cancer Program at Angeles. “And with mesothelioma, it’s holding significant prospect for providing an effective option for patients.”
Mesothelioma is a rare but highly aggressive cancer caused by an exposure to asbestos. There is no known cure. An estimated 3,000 new cases are diagnosed annually, which makes it difficult to fund research and conduct clinical trials with large-enough samples.
“One of our strengths here is immunotherapy clinical trials,” Balmanoukian told Asbestos.com. “The whole goal is using the body’s own immune system to fight the cancer. There was an earlier trial in Italy that showed this drug might work with mesothelioma. I’m a believer. There have been some really nice responses.”
The hope with tremelimumab or any immunotherapy drug is that it could unblock, or unmask, mesothelioma cells and allow the body’s immune system to destroy them without bothering the healthy cells.
When an immune system functions normally, it only destroys cells that are recognized as foreign. It’s how a body fights off a virus or bacteria. Because the body is producing the cancer cells, it does not normally recognize them as foreign.
“Cancer normally tricks the immune system,” Balmanoukian said. “It’s a matter of getting the immune system to recognize those as bad cells.”
One downside of this trial is that there are no guarantees that patients will get the tremelimumab. It is a randomized, double-blind, parallel-group study. For every two patients who get the tremelimumab, one will get a placebo.
Tremelimumab has had limited success in the past with metastatic melanoma, prostate and bladder cancers. Other studies are ongoing.
“There are just limited chemotherapy options now to treat metastatic or unresectable mesothelioma, so clinical trials here are incredibly important so that patients have access to other options that might provide them treatment, and hopefully a benefit,” Balmanoukian said. “Trials of any sorts are important in the development for all patients with cancer.”
Anyone interested in the trial can contact Balmanoukian at the Angeles Clinic. The trial will include one treatment each month for six months.
“My gut is telling me we’ll see a response in some patients, that it will stabilize the disease,” she said. “But I’m hoping we do even better.”