Summer is almost here and the sun is getting hot! What better time to talk about protecting our skin and one of the possible consequences of excessive sun exposure, melanoma.
Melanoma is the most serious form of skin cancer. If it is recognized and treated early, it is almost always curable. But if it is not, the cancer can advance and spread to other parts of the body, where it becomes hard to treat and can be fatal. While it is not the most common of the skin cancers, it causes the most deaths. The American Cancer Society estimates that at present, about 123,000 new cases of melanoma in the US are diagnosed in a year, resulting in approximately 10,000 deaths. Melanoma originates in melanocytes, the cells which produce the pigment melanin that colors our skin, hair, and eyes. The majority of melanomas are black or brown, but they can also be skin-colored, pink, red, purple, blue or white. Recently, there have been a few new treatment options for patients with late-stage metastatic disease that may extend survival, but these treatments can have serious side effects. Researchers continue to look for treatment options that can provide benefit with fewer negative side effects.
This past year, two medications were added to the treatment options for metastatic melanoma. Ipilimumab, an anti CTLA4, is a drug that does have some intense immune system side effects, such as diarrhea and colitis, which may require hospitalization. Patients need to understand the importance of reporting any side effects to their physician to avoid hospitalization and the need for surgical intervention. The second drug approved was vemurafenib, a kinase inhibitor, for patients who have the BRAF v600E mutation. This oral drug makes it easier to take but is often difficult to get covered by insurance. The side effects include rash and the potential for QT prolongation.
Lakeland Regional Cancer Center is proud to have been selected as the only enrolling site in the eastern United States for a metastatic melanoma clinical trial that is utilizing an innovative treatment modality. The information obtained in early clinical trials found that this new technology was safe and provided long lasting benefit to this patient population. LRCC will be working together with The University of California San Francisco and The John Wayne Cancer Institute in California on this Phase II study to validate the results obtained in the Phase I trial.
The trial, developed by OncoSec Medical Incorporated, is designed to evaluate how melanoma tumors respond to treatment with DNA IL-12 and a mild electrical current, called electroporation. This treatment is available for patients who have at least two current melanoma skin lesions, lymph node involvement, or spread to the lungs. Patients are treated three times over an eight-day period. If needed, they can be retreated after several months. The electrical current helps to open up the cell wall and allows the IL-12 to stimulate the cells of the immune system. This then provides a systemic effect for the patient, allowing the immune system to effectively find and destroy the melanoma cells. The procedure is very well tolerated and the side effects are few.
One positive impact this type of treatment will have on patients is that we can offer this to those who have melanoma lesions on the scalp, ears, and face. Currently, the standard treatment is to complete a wide local excision after a positive biopsy. This can be disfiguring and require plastic surgery. At times, it is difficult to get clear margins due to bony structures, cartilage, and blood vessels. This new procedure can be done on lesions of 1 cm or greater, and the early trials showed a regression of the tumor, leaving the tissues and structures intact. The ability to leave ears, noses, and scalp tissue intact makes this treatment a wonderful alternative for our patients.
IL-12 with electroporation can be used in patients who have previously been treated with interferon, interleukin 2, and chemotherapy. Patients with in-transit or satellite lesions are allowed to participate. Patients must have at least two lesions that can be injected, and we are able to inject up to four melanoma lesions at a time. Because we are using a mild electrical current, patients with defibrillators or pacemakers cannot participate. Patients do need to meet a list of criteria to participate in this clinical trial.
Of course, the best way to treat melanoma is to prevent it! It is important for all of us to continue to use our sunscreen, wear a hat when outside in the sun, and use sunglasses with UV protection. Melanoma does occur in the eye and the standard treatment is nucleation of the eye. Proper eye protection can help to reduce that risk and should begin with small children.
As we age, our skin begins to show the damage that we have done throughout our lifetime. Getting a skin check completed by a trained medical professional on a regular basis can help to identify problems early. The earlier a melanoma is found, the better!
For more information regarding the IL-12 electroporation clinical trial, please contact the LRCC Clinical Trials staff at 863-904-1900.
By Manuel Molina, MD
Manual Molina, MD is a board-certified and fellowship-trained surgical oncology specialist. His multi-area surgical expertise includes malignant and benign hepato-biliary and pancreatic diseases, melanoma,sarcoma, esophageal cancer, gastric cancer and other digestive tract cancers. He brings expertise in minimally-invasive laparoscopic procedures for esophageal, stomach, pancreatic, liver, bile duct and colon cancers. He also has a special interest in endocrine surgeries. Dr Molina can be contacted at the main Lakeland Regional Cancer Center number: 863-603-6565.