Drug Shows Promise for Late-Stage Melanoma

The results from a recent clinical trial show that a drug, ipilimumab, helps some patients with late-stage melanoma. Almost half (45.6%) of the patients who received only ipilimumab during this clinical trial were alive after 1 year.

Ipilimumab also gave some patients better control of advanced melanoma. Six months after receiving treatment, the melanoma had not gotten worse in nearly one-third (30%) of the patients who received only ipilimumab.

In this clinical trial, the researchers also found that if melanoma worsened after being under control, some patients responded to further treatment with ipilimumab.

These findings are giving doctors and patients hope. Before becoming part of this clinical trial, all of the patients had received at least one other treatment for advanced melanoma. Medications included interleukin-2, dacarbazine, and temozolomide. None of these medications had worked. But some patients responded to ipilimumab.

Ipilimumab Still Experimental Treatment
These findings are promising, but ipilimumab is still an experimental treatment for late-stage melanoma. It has not received approval from the U.S. Food and Drug Administration (FDA). It is, however, available through a compassionate-use clinical trial.

To receive ipilimumab through a compassionate-use clinical trial, a patient must have serious or life-threatening, late-stage melanoma. Additionally, the patient must not have another option for treating the melanoma, and the patient’s doctor must believe that the benefits of receiving ipilimumab outweigh the risks.

Serious Side Effects Reported
Ipilimumab works by stimulating the patient’s own immune system to kill the cancer cells. Because of this, side effects can occur in the patient’s immune system. These effects are called “immune-related” side effects. In this clinical trial, the most common “immune-related” side effect was diarrhea, which could be so severe that it required treatment with corticosteroids.

Patients also developed colitis (inflammation of the large intestine that may require ongoing treatment), rash, and inflammation of the pituitary gland. The latter requires hormone-replacement therapy.

These side effects do not determine whether ipilimumab will work. Some patients who respond do not have side effects.

It is important to know that ipilimumab does not work for everyone. In clinical trials, the most common reason for stopping ipilimumab is that it does not stop the melanoma from worsening.

How Patients Receive Ipilimumab
Patients receive ipilimumab at a hospital or cancer treatment center. The medication is given by infusion. This means that an intravenous (IV) needle is inserted so that the medication can flow directly into a vein.

In one clinical trial, each infusion took 90 minutes. If the patient responded and did not have toxic side effects, the patient could continue treatment. Those patients who continued, received 3 more infusions. The infusions were given once every 3 weeks.

More Studies Planned
Because the findings are promising, more studies are planned. Currently, ipilimumab may be a treatment option for some patients with advanced melanoma who have not been helped by other treatments for advanced melanoma.

References:
Hodi FS, O’Day SJ, McDermott AD, et al. “Improved Survival with Ipilimumab in Patients with Metastatic Melanoma.” The New England Journal of Medicine. Supplementary Material Published Online June 5, 2010.

U.S. National Institutes of Health, “Compassionate Use Trial for Unresectable Melanoma with Ipilimumab.” Last accessed June 28, 2010.

All content solely developed by the American Academy of Dermatology