Researchers at the University of Texas Southwestern Medical Center are among those studying a new antigen in hopes of developing a vaccine against melanoma
Investigators are examining a tumor-specific protein called recombinant human melanoma antigen A3 (MAGE-A3) to determine whether it will interact with the body's immune system and target melanoma cells.
"In the case of this trial, if we finally get (the vaccine) to work, it will be a wonderful thing," he says.
Lead investigator for the GlaxoSmithKline Biologicals-sponsored trial at UT Southwestern Medical Center, James F. Huth, M.D., says the Dallas academic center is one of about 50 sites in the United States that is conducting this single antigen immunization study on MAGE-A3, which is a surface antigen found on melanoma cells.
"There has been preliminary evidence with small cell lung cancer and melanoma that this antigen has some activity against these tumors. "For the purposes of this study ... we are looking at stage 3 patients who have palpable lymph node disease," Dr. Huth says.
UT Southwestern recently started recruiting for the study and will continue enrolling adults for up to five years, according to Dr. Huth, who is surgical oncologist and professor of surgery, UT Southwestern Medical Center.
Eligible subjects are those who have stage 3 melanoma - confirmed in a node dissection - with no detected disease elsewhere in the body.
Study investigators will determine trial eligibility by sending the lymphatic tissue for testing to determine if MAGE-A3 is present.
"About two-thirds of patients will express the antigen; about one-third will not. If they do not express the antigen, they are not eligible for the trial," Dr. Huth says.
Investigators randomize those who express the antigen in a two-to-one ratio, in which two patients receive the vaccine and one a placebo. The placebo includes administration of an immune adjuvant activating system by GlaxoSmithKline.
Researchers will follow subjects to the time of recurrence or five years.
"I suspect survivors at five years will be followed longer, if there is some efficacy to this trial," Dr. Huth says.
Interferon is the standard treatment for a melanoma patient with lymph node dissection with positive nodes and no other evidence of disease, according to Dr. Huth.
"Interferon certainly has activity against melanoma, so it is useful. But not everyone benefits, and there are serious side effects," he says.
Subjects of this study would be fully informed about the availability of interferon versus the investigational option, Dr. Huth says.
Dr. Huth is hopeful that MAGE-A3 could have efficacy, even though many melanoma vaccine trials have failed during the past few decades.
Disclosure: This study was funded by GlaxoSmithKline.