Pleural Mesothelioma Patients Requested for Clinical Trial
Researchers at the National Institutes of Health Clinical Center in Bethesda, MD have begun recruiting patients with pleural mesothelioma for a Phase I clinical trial. The trial is to study the efficacy of SS1 administered concurrently with the combination chemotherapy treatment of pemetrexed and cisplatin in patients with pleural mesothelioma who have not been previously treated with chemotherapy.
Pleural mesothelioma is a form of lung cancer that is almost always caused by asbestos exposure and is found in the outer lining of the lungs called the mesothelium. Although there is no cure for mesothelioma, it can be treated with varying degrees of success through the use of surgical procedures, chemotherapy and radiation.
Chemotherapy is considered the most effective single modality for the treatment of mesothelioma and is likely to be the most commonly deployed treatment as well. The current chemotherapy standard of care for the treatment of pleural mesothelioma is combination therapy utilizing pemetrexed and cisplatin.
SS1(dsFV)PE38 is a genetically engineered drug. It contains an antibody that binds to a certain protein on mesothelioma cells and a toxin made from a product of a bacterium called Pseudomonas aeruginosa. Researchers hope that the antibody will attach to the cancer cells, allowing the toxin to enter and kill the cells. By combining SS1 with the chemotherapy the researchers hope to improve the survival of the patients.
The trial’s specific objectives are:
- To find out if SS1(dsFV)PE38, together with pemetrexed and cisplatin is safe and tolerable in patients with mesothelioma.
- To determine the maximum tolerated dose of SS1(dsFV)PE38 (the highest dose that does not cause unacceptable side effects).
- To see if SS1(dsFV)PE38 given with pemetrexed and cisplatin has any effect on patients’ tumors.
Those eligible for the study are patients that have been diagnosed with epithelial pleural mesothelioma whose disease cannot be cured with surgery, and have not had prior treatment with chemotherapy.
Nearly 3,000 Americans are diagnosed with mesothelioma each year. Many of them rely on clinical trials for the opportunity to receive new, potentially curative therapies.
SS1(dsFV)PE38 holds the Orphan Drug designation status by the U.S. Food and Drug Administration for the treatment of malignant mesothelioma, but it has not yet been approved. It was designated on 02-11-2002.
See NIH Clinical Research Studies for enrollment information.