Cancer Center leads breakthrough clinical trial

For immediate release: May 30, 2009

GOSHEN IN - A recent clinical trial - led by Goshen Center for Cancer Care - has yielded promising results for the future use of a cancer vaccine. One of the first studies to prove vaccines might have a medical benefit against cancer, study results found the new cancer vaccine doubled the response rate for tumor shrinkage as well as delayed the progression of cancer in patients with metastatic melanoma.

These results were announced May 30 during the American Society of Clinical Oncology annual meeting in Orlando, Fla. As lead author and principle investigator of the trial, Goshen Center for Cancer Care Medical Director Dr. Doug Schwartzentruber presented the results at the ASCO meeting for the first time.

Goshen acted as the coordinating center - and only site in Indiana - for this multi-institute, national research trial that evaluated a novel cancer vaccine for the treatment of metastatic melanoma - a form of skin cancer that has spread to other parts of the body.

The vaccine, sponsored by the National Cancer Institute, is a synthetic fragment from a specific protein found on the surface of melanoma cells. This protein, the gp100 protein, acts as a marker for melanoma cells in the body. The vaccine primes a patient's immune system to find and attack the cancer by locating the gp100 protein. Preliminary findings found the new cancer vaccine doubles the response rates and extends progression free survival in patients with metastatic melanoma.
 
"This study is one of the first to show positive, promising results for a cancer vaccine. That's how we make cancer progress - one step at a time," said Schwartzentruber, who brought the trial to Goshen from the National Cancer Institute 5 years ago.

The 8-year trial tested the benefit of combining the vaccine with the high-dose Interleuken-2. IL-2 is a biological therapy that boosts the immune system. Goshen Center for Cancer Care is one of only about 60 sites that offer high-dose IL-2 therapy to patients.

Involving 21 sites and 185 patients, the study investigated whether IL-2 given with the vaccine would create positive responses for more patients, making the body's immune response even stronger than with IL-2 alone.

"Metastatic melanoma is a difficult disease to treat successfully and is resistant to most therapies," said Schwartzentruber. "These results will give patients and the oncology community hope that we are making progress against the disease."

Before the vaccine could be introduced as treatment for melanoma, said Schwartzentruber, the next step would be to conduct a larger clinical trial to demonstrate the vaccine improves overall survival.

"We are just now processing the findings of this trial but we are in discussions about a larger trial. This trial took 8 years - for a larger trial we would enlist more centers and conduct the trial in a shorter time," Schwartzentruber said. "Not only did this study show a trend toward overall survival, it demonstrated a doubling of response rate to treatment and a delay in the progression of the cancer. It is one of the first times we've been able to prove that vaccines have a medical benefit in the fight against cancer."

Clinical trials have contributed to major medical breakthroughs in cancer treatments and Goshen Center for Cancer Care is committed to cancer research - involved in and sponsoring a number of clinical trials in addition to prevention, screening, diagnostic, treatment and quality of life trials.

"We continue to be very committed to research, recognizing that it is what will move us forward in the treatment of all cancers as we look for ways to improve established therapies," Schwartzentruber said. "The only way we will find better treatments is through clinical trials. Our research also involves looking for new diagnostics because if we find cancer better, we can treat it better."

For additional information on the trial, click here.