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Immunotherapy – Ospedale S. Spirito – Treatment Details
In this clinical trial from Casale Monferrato, Italy in 2001, researchers tested an immune therapy on 31 pleural mesothelioma patients. The patients were given Interleukin-2 (IL-2). IL-2 is a signaling molecule in the immune system that activities white blood cells.
These 31 patients were those who could not be given surgery because their pleural tumors were considered inoperable (“unresectable”). Therefore, there were very modest expectations that the treatment would have a dramatic effect because surgery is a very helpful modality in mesothelioma patients whose tumor can be removed.
Median overall survival was 15 months. There side effects included: cardiac failure (in one patient), and flu-like syndrome in other patients. The researchers concluded that their results “warrants further randomized studies with IL-2 aimed to the patient outcome.”
Today, IL-2 is seldom tried in pleural mesothelioma patients. There are more promising immune therapies such as Keytruda and others.
This was a phase II clinical trial. A phase II trial is designed to find out if the treatment works. Patients in a phase II pleural mesothelioma trial are treated using the dose and method found to be the most effective and safest in the phase I trial of that treatment.
Treatment Details:
Patients: This Phase II study involved 31 patients with malignant pleural mesothelioma.
Treatment: The treatment consisted of the injection of human recombinant Interleukin-2 (Proleukin).
Toxicity: Grade 3 toxicities included cardiac failure and fever. Grade 2 toxicities included neuropathy, neurologic, and gastrointestinal.
Results: Median overall survival was 15 months.
Correspondence: Bruno Castagneto, MD
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