Clinical trials are the best hope for a long-lasting reduction or elimination of metastatic melanoma (called a "durable response" or "complete response" by doctors). The US National Institutes of Health lists 27 late-stage (phase III) clinical trials currently recruiting patients with melanoma. Many of the trials are testing new combinations of existing drugs, new ways to administer them, or new surgical procedures, but some are investigating brand new drugs. The most promising are the following:
Allovectin-7 - This novel gene therapy is injected directly into the tumors of patients with stage III or IV disease, which then alerts the body's own immune system to attack the tumor. Earlier trials of Allovectin alone showed that tumors in 4% to 9% of patients responded to the therapy. The new trial is comparing Allovectin-7 to the standard chemotherapy treatment, either dacarbazine or temzolomide. Made by Vical. Find out if you may qualify for the AIMM trial of Allovectin-7.
oblimersen (Genasense) - Genasense is a unique inhibitor of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced cell death (called "apoptosis"). So by reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Previous studies demonstrated that Genasense combined with the chemotherapy drug dacarbazine tripled response rate and significantly increased overall survival compared to dacarbazine alone. Made by Genta. Find out more about the AGENDA trial of oblimersen.
MVax - MVax is a melanoma vaccine prepared from the patient's own cancer cells. Several studies have shown that MVax followed by interleukin-2 can lead to a complete response in up to 13% of patients, double that of interleukin-2 alone. MVax is also effective in patients with stage III melanoma when given post-surgery: it doubled the 5-year survival rate compared to surgery alone. Made by AVAX Technologies. Find out more about the MVALDI trial for MVax.
ipilimumab (MDX-010, MDX-101, or BMS-734016) - Ipilimumab is an antibody that activates the body's immune system to fight melanoma by inhibiting the CTLA-4 molecule. Three previous phase II clinical trials have shown that treatment with ipilimumab results in a one-year survival rate of 47% to 51% for people with stage III or IV melanoma, which is almost double the average. The current trial is comparing ipilimumab to a dummy treatment (placebo) in patients with stage III melanoma who have already undergone surgery. Made by Medarex and Bristol-Myers Squibb. Find out more about the EORTC 18071 trial for ipilimumab.
OncoVEXGM-CSF - OncoVEXGM-CSF is a vaccine that works by spreading within tumors and causing the death of cancer cells while stimulating the immune system to destroy metastatic tumors. Previous results from 50 patients with inoperable stage IIIc/IV melanoma demonstrated that 28% of patients responded, including 12% with a complete response. The new trial is enrolling patients with previously treated but inoperable stage IIIb, IIIc or IV melanoma and is designed to compare OncoVEXGM-CSF to a naturally-occurring substance in the body called a "granulocyte monocyte colony stimulating factor" (GM-CSF), which increases white blood cells. Made by BioVex. Find out more about the trial for OncoVEXGM-CSF.
Why Participate in Clinical Trials
Those who take part in clinical trials get access to the latest treatments that are often not available anywhere else. These treatments may be better than the standard of care and may offer the only hope for those with advanced disease. Simply put, participation in clinical trials by patients like you is the only way research will advance toward an eventual cure for melanoma. Talk about the possibilities with your doctor!
ClinicalTrials.gov. US National Institutes of Health. 10 February 2009.