Clinical Trial for Potential Mesothelioma Treatment Back On Track After Temporary FDA Hold
In early June, Mesothelioma Help reported on the anticipated approval of two immunotherapy drugs by the U.S. Food and Drug Administration that could ultimately benefit mesothelioma patients. This month, one of the drugs overcame a brief setback when the FDA placed a “clinical hold” on the clinical trial. Juno Therapeutics’ chimeric antigen receptor (CAR) T-cell therapy treatment was stopped for five days, but is back on track after addressing the FDA’s concerns.
According to a July 7 press release from Juno Therapeutics, its Phase II JCAR015 clinical trial for leukemia patients was temporarily halted after two patients passed away. Juno reports the deaths came after fludarabine, an antimetabolite chemotherapy drug used in the treatment of chronic lymphocytic leukemia, was added to the pre-conditioning regimen.
The JCAR015 trial treats patients with an infusion of the patient’s own T- cells that have been genetically modified to express a CAR that will bind to leukemia cells that express the CD19 protein on the cell surface, according to ClinicalTrials.gov.
Immunotherapy, now one of the most promising treatments in the fight against mesothelioma, uses the patient’s immune system to fight cancer. According to the American Cancer Society, immunotherapy can include stimulating your own immune system to work harder or smarter to attack cancer cells, or introducing immune system components, such as man-made immune system proteins, into the body to fight back. Immunotherapy treatments are sometimes used with other types of cancer treatments.
On July 12, Juno issued another press release indicating that the FDA released the clinical hold. According to the release, JCAR015’s revised protocol will use cyclophosphamide, an alkylating agent chemotherapy used in the treatment of leukemia, for pre-conditioning only.
As is shown by the quick action of both the FDA and Juno Therapeutics, U.S. clinical trials are closely monitored and are run according to strict guidelines to ensure the safety of the participating patients.
Clinical trials continue to be one of the best options for patients struggling to find a new, effective treatment for mesothelioma. Offered through hospitals and medical research institutions, clinical trials test new methods of screening, prevention, diagnosis, or treatment of the disease. They also provide researchers with critical information needed to allow them to move their findings from the lab to the patients.
The prognosis for mesothelioma patients is usually grim: the average survival time varies from four – 18 months after diagnosis. For the nearly 3,000 Americans diagnosed with the disease each year, immunotherapy clinical trials may offer them a breakthrough treatment not otherwise available.
Read here to find out about other immunotherapy treatments in trial that are promising in the treatment of mesothelioma patients:
If you or someone you know is suffering from mesothelioma, check with your physician to determine if any current studies exist for your particular case.
To find out more about the JCAR015 clinical trial see ClinicalTrials.gov.