A National Mesothelioma Virtual Bank to Improve Research

As the number of mesothelioma cases in our country continues to increase, the United States is striving to form a National Mesothelioma Virtual Bank (NMVB), which would collect samples of mesothelioma pleural, peritoneal and pericardial tissues, along with blood and DNA samples. Once the samples have been collected, they would then be cataloged and made available for study through an online interface. The interface would then take newer findings and coordinate them to work in conjunction with existing cancer research.

While there is already a great deal of research being done, the bank will enable researchers everywhere to take their theoretical work and convert it into more practical approaches that could help patients much sooner.

The NMVB currently has three participating institutions: University of Pittsburgh, University of Pennsylvania, and New York University. The other participants supporting the NMVB include the Mesothelioma Applied Research Foundation, University of Hawaii, University of Vermont, and Fox Chase Cancer Center.

If you would like to participate in the NMVB’s prospective study you must be 18 years old or older and be able to provide informed consent. This can usually be obtained at the doctor’s office, clinic visits or upon hospital admission.

People who are not eligible to participate in the study include people under the age of 18 and prisoner-patients, who are excluded due to federal limitations. Individuals will not be excluded due to race, ethnicity, gender, or HIV status.

If you would like more information on the NMVB click here.

Chemotherapy combination adds 5 weeks to lung cancer survival

When used in conjunction with chemotherapy, a new treatment has been shown to increase life-span by five weeks among lung cancer patients.

A study released last week indicates that the drug Erbitux, created by ImClone Systems Inc, can both help lung cancer survival and decrease tumor size when used with chemotherapy treatments. The study involved 1,125 patients; overall survival was 11.3 months for patients on the combination therapy, compared with 10.1 months for the group receiving just chemotherapy. Tumors shrunk in 36.3 percent of patients treated with Erbitux, also known as cetuximab, compared with 29.2 percent of patients on chemotherapy alone, according to a statement from the American Society of Clinical Oncology.

Prior to the publication of these promising results, the only non-chemo treatment for lung cancer had been Genentech Inc's Avastin, which combats non-small cell lung cancer.

Erbitux is an antibody already approved for treating colorectal as well as head and neck cancers. It is designed to block a protein called epidermal growth factor, and has so far exhibited only minor side effects. The most common complaint among trial participants was the appearance of an acne-like rash, seen among 10.4% of patients using the combination therapy, compared to .2% of patients receiving only chemo.

For more information, click here.

The cruel economics of cancer

Within a decade, cancer is expected to surpass heart disease as America's biggest killer.  Currently, the disease strikes one in three Americans and kills one in four; it claims the lives about 1,500 Americans daily.

To combat these climbing numbers, the government has channeled about $75 billion into oncology studies since 1971. But even in the midst of generous funding and tireless research, the cancer death rate has only dropped by 7% over the past three decades. Why?

As this question becomes more pressing, attention is shifting to the FDA and its methods of approving cancer treatments. Some authorities believe the FDA is so wrought with red tape and inefficiency that it is significantly jeopardizing the survival capacity of American cancer patients. A recent study at Tufts revealed that only 8% of experimental cancer drugs receive FDA approval, compared to 20% of medicines for all other diseases. Steven Creel of Austin, Texas, can speak to this problem personally.

Steven was diagnosed with an aggressive form of kidney cancer in 2003. Because he was at high risk of the cancer recurring after surgery, he began to explore other options. Steven entered a clinical trial for the experimental treatment Oncophage and encountered impressive results. Essentially, Oncophage is a vaccine that summons the immune system to fight off cancer cells. "There were literally no side effects. I would have the treatment and then play tennis," he said. Steven has been cancer-free for five years. "I feel very, very fortunate."

Despite success with patients such as Steven, Oncophage--like so many other experimental cancer drugs--hit a wall late in the clinical trial stages. Because of FDA criteria, 124 patients had to be removed from the trial, rendering the results less definitive. Oncophage's developer, Antigenics, suffered a huge financial loss because the study's outcome was consequentially inconclusive; the drug showed an increase in life span for only a small margin of patients--possibly because of the diminished pool of subjects--so the FDA did not deem the improvement substantial. Antigenics uprooted and moved to a country more receptive to their research needs: Russia. Within 10 months, the drug that saved Steven's life but was rejected in America became approved for use in Russia. Now, Antigenics is working the European Union for approval abroad. The company hopes to establish solid financial footing so it can return to America for another round of clinical trials in order to satisfy the FDA.

The FDA knows there is a problem with the slow and infrequent approval of cancer drugs, but is unwilling to adjust trial requirements. Richard Padzur heads the FDA's Office of Oncology Drug Products. Dr. Padzur has garnered criticism for his unrelenting and decisive views on cancer drug approvals, but he insists that the patient's safety and the drug's efficacy are the FDA's top priorities. "Believe me, if there were a clear survival effect, the drug would be approved," says Pazdur.

For many, the solution lies in the manner in which the FDA examines clinical trials. In 2004, the FDA launched the Critical Path Initiative to expedite and streamline clinical trials for cancer drugs, but since 2005 only 18 new treatments have been approved while hundreds wait in the pipeline. Many FDA officials hope to see the agency overhaul its approval methods for cancer medicines, much like it did for AIDS drugs in the '80s and '90s.

To read more on this topic, click here.

A new prize for cancer research

Obtaining cancer research funding can be trying. Often, seeking money for research is a matter of pleasing supervisors of National Institutes of Health or appeasing gatekeepers of advocacy groups.

A new prize, however, is offering $1 million annually to encourage innovative cancer treatment research. The Gotham Prize was established in May by two hedge fund managers and a doctor from Harvard Medical School. In addition to the $1 million prize, there is also a stipend of $250,000 available for research in pediatric oncology.

The first winner was Alexander Varshavsky, the Smits Professor of Cell Biology at California Institute of Technology. His novel idea is called deletion-specific targeting, based on DNA that is missing from tumor cells but found in normal healthy cells.

"(It) involves, in a nutshell, the finding of a genuine Achilles Heel of cancer cells, i.e., their potentially vulnerable feature that won't change during tumor progression," Varshavsky said in a statement. "A deletion-specific targeting-based drug is envisioned as a sophisticated molecular device that enters a cell, 'examines' it for the presence of cancer-specific DNA deletions, and thereafter 'decides' whether it entered a cancer cell, in which case the drug activates its warhead and kills that cell," he added.

The founders of the Gotham Prize hope to establish an exchange of ideas about cancer that will help researchers think outside the box.