Dr. Andrea Wolf Discusses New Mesothelioma Vaccine Clinical Trial
During my thoracic surgery fellowship at Brigham and Women’s Hospital, I was fortunate enough to learn mesothelioma treatment techniques directly from the legendary specialist and pioneer Dr. David Sugarbaker.
While there, I had the privilege of working on several early-phase clinical trials, including those focused on HITHOC, a heated chemotherapy technique used to treat pleural mesothelioma.
Now, nearly a decade later, as Director of the New York Mesothelioma Program at Mount Sinai, I’m getting the chance to innovate and improve on mesothelioma therapies.
With our new clinical trial at Mount Sinai Hospital in New York City, my research team and I are investigating a vaccine for pleural mesothelioma patients to improve outcomes for patients eligible for surgery.
Clinical Trial Prioritizes Mesothelioma Surgery Safety
The Poly-ICLC vaccine is a neoadjuvant treatment, meaning it’s intended for patients eligible for surgical resection. One of our goals with this research is to document the safety of this vaccine for mesothelioma patients, as it is safe in other solid cancers. We will also determine its benefits and how to use this vaccine most effectively during a patient’s treatment plan.
One of my priorities is individualizing surgery for each patient. It’s necessary to perform the best operation for each patient without compromising their health. By offering this vaccine treatment shortly before surgery, we’re avoiding delays in treatment and not compromising a patient’s recovery from surgery.
With this study, we have the freedom to determine which type of surgery is most appropriate for each patient. We can often resect as much cancer tissue during a pleurectomy and decortication as with an extrapleural pneumonectomy in terms of results for margins.
A surgeon can rarely remove all cancer cells during mesothelioma resection. If we can prevent a patient from losing a lung, it’s an option that avoids a challenging recovery and could add years to their life. While we still perform extrapleural pneumonectomy if needed, we are finding that we can offer better outcomes with pleurectomy and decortication for most patients.
With this vaccine and other clinical trials, we hope to turn mesothelioma into a chronic illness where patients live 15 years or longer.
Researchers have used the U.S. Food and Drug Administration’s Investigational New Drug Application for the Poly-ICLC vaccine in other cancers, including glioblastoma, an aggressive brain cancer. At Mount Sinai, my colleagues have used the vaccine with other solid malignancies, and we expect it to help with mesothelioma.
Mesothelioma Vaccine Attracts Immune Cells to Tumor
Before surgery, we administer the vaccine through two injections directly into the mesothelioma tumor. The vaccine stimulates and attracts immune cells to the tumor site to destroy the cancer cells.
We’ll investigate the tumor microenvironment for cellular changes as the study continues. For example, we expect the vaccine to increase the number of T cells and dendritic cells within the tumor, which will make the tumor more responsive to immunotherapy if it were to recur.
There will likely be some benefits with this vaccine that we haven’t anticipated. Once the immune system recognizes mesothelioma tumor cells, patients may benefit from long-term protection against mesothelioma.
This is a phase I trial, meaning we’re looking primarily at safe dosages that patients can tolerate.
So far, we’re seeing an acceptable level of safety. The most common adverse effect is a low-grade fever, or mild flu-like symptoms, after the injection that resolves with over-the-counter fever reducers, such as Tylenol.
We also perform a biopsy during the procedure using the same needle. As with any procedure in the chest, there is a risk for pneumothorax (or air in the chest cavity) that resolves either on its own or with a simple intervention.
New Trial Doesn’t Delay Surgical Care
What’s most exciting about this new study is that I’ve designed the protocol to ensure no delays in treatment.
As principal investigator of the first clinical trial using the Poly-ICLC vaccine in mesothelioma, it was my priority that surgical patients continue to receive the best care available. Patients in our practice can potentially benefit from this vaccine and still undergo their scheduled surgery within a month.
The type of surgery a patient receives, either a pleurectomy with decortication or an extrapleural pneumonectomy, is unlikely to make a difference in the vaccine’s effectiveness. So far, each of the patients we’ve enrolled has undergone a lung-sparing pleurectomy and decortication.
Compared to other mesothelioma clinical trials, patient visits are relatively standard and designed to accomplish multiple objectives, reducing the number of times they need to visit the clinic.
Additionally, patients who qualify for adjuvant therapy after surgery can remain in the trial. We’ll continue to collect data on patients even if they receive chemotherapy or radiation for mesothelioma later in their treatment plan.
Early Results Encouraging for Further Study
Our data up to this point supports that this is a safe dose for patients. There are no apparent signs of safety issues with the Poly-ICLC vaccine, and expanding the trial is our next step.
Over the next 12 to 18 months, we’ll continue analyzing data to determine what a phase II study may look like. We will also examine the possibility of adding immunotherapy to the trial. We hypothesize that a synergy between the vaccine and immunotherapy for mesothelioma will promote success.
The vaccine manufacturer suggests that intramuscular booster injections may improve long-term effectiveness. As we collect more data, we’ll consider more options for expanding and refining the trial in phase II.
At Mount Sinai, we have multiple ongoing trials for patients with advanced disease that focus on combining immunotherapies. We’re also part of a multicenter study evaluating the role of radiation after surgery and have more studies in the pipeline based on new cancer targets we’re identifying in the lab.
I couldn’t be prouder of this study and our team for taking outstanding care of patients and collecting such excellent data. The potential for this mesothelioma vaccine is tremendous, with little downside. I’m confident that the work we’re doing now will help more patients in the future.
To mesothelioma patients looking for new treatments, I encourage you to stay optimistic. We have many more options now than we did just four years ago. Go to a multidisciplinary treatment center like Mount Sinai, where a team of experts can create an individualized treatment plan.
Every patient’s disease is different, and the best mesothelioma specialists look at prognostic indicators and biomarkers to determine the optimal course for successful outcomes. Explore your options before settling on aggressive therapies and find a doctor committed to preserving your health.