Q & A with Dr. Doug Schwartzentruber,
Medical Director of Goshen Center for Cancer Care

For immediate release: May 30, 2009

Q: How did Goshen Center for Cancer Care get involved in the trial?
A: "The study started at the National Cancer Institute," said Dr. Schwartzentruber, lead author of the trial. "I brought the clinical trial when I came to Goshen 5 years ago from NCI. I was the protocol chair over the study, and remained protocol chair and principle investigator when I came to the cancer center. Goshen Center for Cancer Care fully supported the trial."

Q: What does it mean for Goshen Center for Cancer Care to be the Coordinating Center?
A:
"Not only are we the coordinating center for this multi-institutional trial, but we are the only participating site in the state," Schwartzentruber said. "Goshen is responsible for tracking of everything centrally - managing the data integrity, auditing trial sites and summarizing the data in reports"

Q: How many sites participated?
A: "We began the trial with 21 sites and currently have 17," Schwartzentruber said. "Participating sites all have expertise with high-dose IL-2. There are only 60 sites nationally that are considered proficient to give IL-2, and Goshen Center for Cancer Care is one of them."

Q: What does this mean to someone who has been diagnosed with metastatic melanoma?
A: "Metastatic melanoma is a very difficult cancer to treat successfully because it is resistant to most drugs. The trial proved that the vaccine enhanced the effect of IL-2. Response rates were doubled with the vaccine - twice as many patients had a positive response and there was a delay in the progression of the cancer. The study also showed a trend toward overall survival."

"The clinical trial results also lend support for successfully combining other biologic treatments. Both IL-2 and the cancer vaccine are considered biologic therapies, meaning they help a patient's own immune system fight off the cancer. Other treatments, such as chemotherapy, attack cancer cells directly-while also damaging healthy tissue and cause undesirable side effects."

Q: What's next? Is there a timeframe for when this could be uses for melanoma treatment?
A: "We are just now processing the findings of this trail but we are in discussions about a larger trial. Because of the size of the trial (185 patients) we may need to do a larger trial to demonstrate that the vaccine also improves survival - we need to confirm the trend that this trial showed."

Q: In this trial, what does "vaccine" mean exactly?
A: "Vaccines stimulate the immune system to fight off something foreign. We think of vaccines as ways to prevent an infection. In cancer, we are using vaccines when cancer is already established in the body. We are using the vaccine to build the immune system to fight the existing cancer."

The vaccine used in this trial is made to mimic a fragment of a specific protein found on the surface of melanoma cells. The protein is a marker for these cancer cells. The vaccine stimulates white blood cells in the body to recognize, seek out and kill the melanoma cells by locating this specific marker (antigen).  IL-2 causes these cancer specific white blood cells to multiply."

Q: Could this lead to a cancer vaccine in the future?
A: "Potentially this could lead to a vaccine. This is one of the first times we've proven vaccines might have a medical benefit against cancer. At this point we are still a ways a way, but it is progress. That's how we make cancer progress - one step at a time, building on our knowledge."

Q: Will Goshen Center for Cancer Care continue clinical trials and research?
A: "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. The only way we will find better treatments is through clinical trials. Our research also involves looking for new diagnostic methods because the better we are able to find the cancer, the better we can treat it."

For additional information on the trial, click here.