Stimuvax available trially in North Carolina!!

[RandyW]

Lung cancer vaccine to be tested locally

UNC-CH scientist will lead the study

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ELIGIBILITY FOR THE TRIALUNC-Chapel Hill is participating in a study that will test a treatment vaccine for lung cancer. UNC-CH is not yet recruiting patients but expects to start in a few weeks.

To be eligible, patients must have inoperable Stage III lung cancer -- disease that is confined to the lungs and chest -- and have recently completed chemotherapy and radiation.

For more information on the clinical trial of Stimuvax, visit www. clinicaltrials.gov.

To find the study, research sites that are currently recruiting and eligibility criteria, search for "Stimuvax" or "lung cancer vaccine."

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Jean P. Fisher, Staff Writer

A UNC-Chapel Hill scientist is leading a major new clinical trial of a novel cancer vaccine that offers a rare bit of hope to lung cancer patients.

Dr. Mark A. Socinski, a lung cancer specialist and associate professor of medicine at UNC-Chapel Hill, will help test an experimental vaccine that mobilizes patients' own immune systems to battle lung cancer cells.

The trial, which will begin recruiting patients locally in a few weeks, is the latest effort aimed at establishing vaccines as a viable treatment for cancer. Similar vaccines that target breast and other cancers are being tested in early stage trials at UNC-CH, Duke University and other research sites.

"We have not proven that [cancer vaccines] can clearly do what we want them to do," Socinski said.

The trial, which will test a vaccine being developed in this country by the pharmaceutical company EMD Serono, is a Phase III clinical trial -- a final step paving the way for regulatory approval of a new drug or treatment.

With 1,300 patients, it is one of the largest cancer vaccine studies done to date. Paid for by EMD, which has offices in Durham, it will enlist patients at 250 sites in 30 countries, with Socinski leading the U.S. portion of the trial.

The trial is significant because it targets lung cancer, the No. 1 cancer killer and a disease that has few good treatment options. Nationally, only about 15 percent of patients with lung cancer survive more than five years after their diagnosis.

Depending on how far their cancer has progressed, lung cancer patients may or may not have surgery. Most receive chemotherapy and radiation, but then doctors and patients must simply watch and wait to see whether treatment works or whether the cancer continues to grow.

That is unacceptable to patients such as Tomma Hargraves, a Wake County speech pathologist who was diagnosed in November with inoperable lung cancer that had already spread throughout her lungs and chest.

Hargraves, 58, said she hopes the treatment will be a success because options are so limited.

"[Clinical trials] give you access to the most aggressive treatments available -- you just can't say no to that," Hargraves said. She is not a participant in the lung cancer vaccine trial -- UNC-CH doctors have not yet enlisted patients -- but is participating in another drug trial under Socinski's care.

No treatment vaccines for cancer are currently on the market. The only cancer vaccines routinely available to patients are preventive ones that target viruses known to cause certain cancers. One vaccine protects patients against infection with hepatitis B, which is linked to some liver cancers. The other combats two types of virus that together cause 70 percent of all cervical cancers.

Building immunity

The lung cancer vaccine, called Stimuvax, does not prevent lung cancer. Instead, it is designed to help the natural immune defense in patients with active disease to better recognize and kill cancer cells.

The immune system has difficulty doing that on its own because cancer cells, which are mutated versions of healthy cells, do not appear to the body to be markedly different from healthy tissues. So the immune system fails to recognize cancer as a threat.

Stimuvax targets a specific protein that is produced in large quantities by lung cancer cells. Once injected, the vaccine floods the body with segments of the protein, called MUC1, in hopes of marshalling the immune system to attack the cancer cells as hostile invaders.

The lung cancer vaccine showed promising results in a smaller, earlier clinical trial. That study tested the vaccine in patients whose lung cancer was concentrated in the lung and chest area, and in patients whose cancer had spread throughout the body.

Overall, patients treated with Stimuvax survived four months longer than patients in a control group, who did not get the vaccine, said Dr. Philip Breitfeld, EMD Serono's medical director for oncology. But the therapy was especially promising for people whose cancer was contained to the chest area. They survived twice as long -- 30 months -- as patients who did not get Stimuvax, who survived just over 13 months.

Based on those results, the latest Stimuvax trial will recruit only patients with lung cancer that has spread within the chest.

"The hypothesis is that the boosting of the immune system works best in patients without metastatic disease," said Breitfeld, who is based in Durham.

Staff writer Jean P. Fisher can be reached at 829-4753 or jfisher@newsobserver.com.

[klmline]

I have not been able to find one member on this Site who's been enrolled in or is currently participating in the Multi-Center Phase III Randomized, Double-Blind Placebo-Controlled Study of the Cancer Vaccine Stimuvax® (L-BLP25 or BLP25 Liposome Vaccine) in Non-Small Cell Lung Cancer (NSCLC) Subjects With Unresectable Stage III Disease. When the oncologist spoke to Dr. Shepherd's(Frances Shepherd, MD, FRCPC, Principal Investigator, Medical Oncology Princess Margaret Hospital, 610 University Avenue, 5-104, Toronto, ON M5G 2M9A, Canada) assistant about enrolling patients in the trial he was first told that Princess Margaret Hospital wasn't participating in the trial and when he questioned further by referencing the Stimuvax Trial at the clinicaltrials.gov site(Canada Research Site, Toronto, Canada; Recruiting) he was then told that yes they would be running the trial but it had not begun yet. I don't know how this is possible when Dr. Shepherd works out of Princess Margaret Hospital and furthermore she is the lead investigator for the trial. Why do they currently show this trial site as recruiting if they aren't? Could someone please let me know if they have been able to enroll and if so where?

[Connie B]

You may not find anyone on this Site that is enrolled in this trial. Randy does a wonderful job of researching and shares information with all of us out of the goodness of his huge heart. Maybe if you asked Randy to investigate this a little further he can maybe find more information out about it for you.