An exciting new mesothelioma clinical trial will study one approach for improving how well immunotoxin drugs work.
The phase I trial is enrolling peritoneal and pleural mesothelioma patients.
Immunotoxins, which are targeted therapies, attach to and destroy cancer cells. This approach already has shown promise in a small clinical trial.
This new clinical trial will give mesothelioma patients an immunotoxin in combination with another substance to suppress the immune system.
The goal of the National Cancer Institute (NCI) clinical trial is to learn how safe and tolerable the combination of the immunotoxin and immune suppressant is in people with advanced mesothelioma.
Helping Immunotoxins Treat Mesothelioma Better
In previous clinical trials, immunotoxins have proven effective for reducing the size of mesothelioma tumors in a small portion of patients.
Unfortunately, a large number of mesothelioma patients did not respond to this therapy.
The NCI clinical trial aims to address why so many people with mesothelioma do not respond to immunotoxins.
When immunotoxins are injected into the body, the body reacts in the same way it often responds to bacteria or viruses — it creates an immune response.
While immunity against harmful bacteria and viruses is a good thing, immunity against an immunotoxin is not. The body’s immune reaction creates antibodies to neutralize the drug, making it useless.
If researchers figure out how to stop the body from making antibodies against the immunotoxin drug, the treatment should work better against mesothelioma.
An earlier clinical trial involving 10 patients with advanced disease suggests this approach holds promise as a more effective mesothelioma treatment.
Boosting Immunotoxins to Fight Mesothelioma
NCI researchers will start with an immunotoxin drug called LMB-100.
Different immunotoxins target different types of cancer cells. LMB-100 is an immunotoxin designed to target mesothelioma cells.
The researchers will treat each patient with a combination of the immunotoxin and an immune suppressant drug called SEL-110.
Researchers hope the drug will prevent the body from forming immunity against the immunotoxin.
What Are Phase I Clinical Trials?
Phase I clinical trials test the safety, side effects, best dose and timing of a new treatment.
The dose of the study drug usually is increased a little at a time. This helps researchers find the highest dose that does not cause serious and harmful side effects.
Phase I clinical trials typically include a small number of patients who have not been helped by other treatments. Although curing patients or shrinking tumors is not the goal of phase I trials, this sometimes happens.
Who Qualifies for This Clinical Trial?
To be eligible to participate in this trial, patients must:
- Be 18 or older
- Be diagnosed with pleural or peritoneal mesothelioma (either epithelial or biphasic) that cannot be cured with surgery
- Have disease that can be measured with conventional methods or with spiral CT scan
- Have received at least one prior chemotherapy treatment that included pemetrexed and cisplatin or carboplatin
- Have no other options for standard curative treatment