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Colon Cancer Vaccine Study Begins in Savannah Next Month

Posted on: Friday, 16 June 2006, 15:00 CDT

By Anne Hart, Savannah Morning News, Ga.

Jun. 14--Imagine having a colon cancer tumor surgically removed, then a vaccine made from that tumor's cells injected into your body to prevent the cancer from returning.

An international study, expected to start next month in Savannah at the Nancy N. and J.C. Lewis Cancer & Research Pavilion at St. Joseph's/Candler, involves injecting such custom-made vaccines into colon cancer patients.

Dr. Herbert C. Hoover, director and chief of surgical oncology at the pavilion, will be the study's co-principal investigator. The other investigator is Dr. Cornelius Punt in the Netherlands.

Hoover and Michael Hanna, founder and chief scientific officer of Intracel, the Frederick, Maryland-based company behind the vaccine, have been working together to develop the vaccine for almost three decades.

The vaccine called OncoVAX targets the increasing number of Stage II colon cancer patients. It's administered after surgery to help reduce the recurrence of colon cancer.

The vaccine trains a patient's immune system to attack colon cancer cells.

"This is unprecedented to use tumor cells as the source of the vaccine to prevent recurrence of cancer," said Hanna.

Chemotherapies currently exist for patients in Stage III or Stage IV of colon cancer, but surgery is the only standard treatment for those in Stage II, according to the National Cancer Institute.

Despite undergoing complete surgical removal of the cancer, 25 to 40 percent of patients with Stage II colon cancer experience recurrence of their cancer, according to NCI.

Intracel received approval from the U.S. Food and Drug Administration for special protocol assessment to start a pivotal phase III clinical trial of OncoVAX. That translates to a "clear path to drug approval," Hanna said.

The first site and training center for the study will be Savannah, then extend to about 30 other hospitals.

"Patients who have colon cancer need to make sure their doctors are aware of this," Hoover said.

Here's how the study is expected to work.

Eligible patients with Stage II colon cancer have surgery to have a colon cancer tumor removed.

Cells harvested from that tumor are sent to Europe where a sterile vaccine is made using those cells.

The patient then returns four to five weeks after surgery to have three injections of that custom-tailored vaccine injected on an outpatient basis.

Each injection is done about a week apart. A final vaccine is administered after six months.

Not all Stage II cancer patients will be eligible to receive the vaccine.

"Patients need to realize it's not going to be available for everyone immediately," Hoover said.

Creating the vaccines involves various challenges including obtaining a sufficient number of cells from each tumor to create four injections per patient.

"We don't want to mislead the public that we have a cure for cancer," Hoover said, "but we hope we do. We are very excited with the results to date. This is the definitive trial that will tell us."

The study will first be open to St. Joseph's/Candler patients with the ultimate goal to eventually open it up to patients from other area hospitals.

Overall, the study in the United States and Europe will include about 560 patients.

Past studies show the vaccine lowers the recurrences of colon cancer or increases the amount of time between recurrences, Hoover said.

OncoVAX is expected to hit the market in 2010.

By then, the number of Stage II colon cancers diagnosed will likely increase from 40 percent of all colon cancer patients to almost 70 percent, Hanna said.

He attributes the increase to advanced diagnostics, such as having colonoscopies or less invasive screenings such as sigmoidoscopies as part of routine physicals.

Most colon cancers are treatable if caught early.

"These two things, along with some blood tests that are used, have improved the ability to detect colon cancer at a much earlier stage," Hanna said.

"We are getting less patients who have progressed to an advanced stage."

THE STUDY: A randomized multicenter study on a colon cancer vaccine for patients with Stage II colon cancer is expected to start next month in Savannah and will eventually be held at other U.S. sites as well as in the Netherlands, Germany and Great Britain. About 560 patients are needed to take part. Health risks can be involved in clinical trials. To participate in the study, call St. Joseph's/Candler at 819-5704.

COLON CANCER: More than 130,000 cases of colorectal cancer are diagnosed in the United States each year with 50,000 deaths, according to the National Institutes of Health.

Colorectal cancer is the second leading cause of cancer deaths.

In most cases, this disease is treatable if caught early by colonoscopy.

THE DISEASE IS CLASSIFIED IN FOUR STAGES:

--Stage I: Tumor in the inner layers of the colon.

--Stage II: Tumor has spread through the muscle wall of the colon.

--Stage III: Tumor that has spread to the lymph nodes.

--Stage IV: Tumor that has spread to distant organs

DR. HERBERT C. HOOVER: Dr. Hoover participated in the first clinical study of the colon cancer vaccine OncoVAX in 1981 at the Johns Hopkins School of Medicine and has continued to collaborate with Intracel over the past 25 years to bring OncoVAX to its current state of clinical development.

Hoover moved to Savannah last year from Lehigh Valley Hospital and Health Network in Pennsylvania. He's the co-principal investigator for a study on the colon cancer vaccine expected to begin in Savannah next month.

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To see more of the Savannah Morning News, or to subscribe to the newspaper, go to http://www.savannahnow.com.

Copyright (c) 2006, Savannah Morning News, Ga.

Distributed by Knight Ridder/Tribune Business News.

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Source: Savannah Morning News

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