myMeso.org | Mesothelioma Blog

A New York medical center specializing in the treatment of mesothelioma has announced a new clinical trial accepting patients. The Mesothelioma Center within the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital and Columbia University Medical Center is launching a program of targeted radiation and chemotherapy protocol for pleural mesothelioma, a cancer of the lung’s lining that is almost always caused by previous exposure to asbestos.

It is hoped the new treatment will replace or delay the need for the standard treatment in these cases, a pleural pneumonectomy, which involves removal of the lung and which can be extremely debilitating to patients.

According to a press release from the medical center, Dr. Robert Taub, the study’s principal investigator, director of the Mesothelioma Center at NewYork-Presbyterian/Columbia and professor of clinical medicine at Columbia University College of Physicians and Surgeons, says, “Current surgical and chemotherapy treatments of patients with malignant pleural mesothelioma are unsatisfactory, and have not been shown to significantly prolong survival. In this study, we will investigate whether a combination of chemotherapy and radiation targeted directly at the lung’s lining can improve outcomes while avoiding surgery. In addition, this approach has shown to have minimal toxic side effects compared to systemic chemotherapy.”

The Mesothelioma Center is the only one nationwide that is offering this experimental therapy to treat pleural mesothelioma.

The study is being conducted at the Mesothelioma Center within the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian Hospital and Columbia University Medical Center. According to the release, participating patients will receive several rounds of targeted chemotherapy using the drugs cisplatin and doxorubicin via surgically implanted catheters. Some patients will be randomly selected to receive additional systemic (intravenous) chemotherapy using the drugs cisplatin and pemetrexed. All patients will receive targeted radiotherapy using the P-32 radioisotope.

Patients may elect to receive additional surgical treatment, including removal of the affected lung lining or lung. Subsequently, patients will be offered outpatient systemic chemotherapy with cisplatin and pemetrexed.

For more information, visit www.hiccc.columbia.edu.

Merck & Co. announced May 27 that it is proceeding to Phase III clinical trials for vorinostat, which is currently marketed under the name Zolinza. The drug is an oral histone deacetylase (HDAC) inhibitor, and is being tested in patients with advanced malignant pleaural mesothelioma previously treated with systemic chemotherapy. Merck is currently enrolling patients in the Phase III trial.

According to the company’s news release, available in its entirety on the Mesothelioma Applied Research Foundation web site, the trial is moving forward after a favorable review of currently available safety and efficacy data from the Phase II portion of the study. This is an international study, expected to enroll 660 patients with testing centers in the United States, Belgium, Germany, the Netherlands, New Zealand, Spain, Sweden and the United Kingdom. It will be an ongoing randomized, double-blind, placebo-controlled trial.

Information provided by Merck says the trial will examine the safety, tolerability and anti-tumor activity of oral vorinostat with best supportive care as compared to best supportive care plus placebo in patients with advanced mesothelioma who have failed or are intolerant to prior chemotherapy, icnlucing pemetrexed in combination with either cisplatin or carboplatin.

Primary endpoints of the Phase III trial include overall survival as well as characterization of the overall safety and toxicity of vorinostat in patients with advanced malignant mesothelioma.

Patients interested in more information about the trial and how to enroll should call toll-free 1-866-890-6619 (in the U.S.) and 1-888-577-8839 (outside the U.S.) or visit the Merck Cancer Trials web site.

Zolinza is currently approved in the U.S. for treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recrruent disease on or following two systemic therapies.

On April 21 I reported that a Madison, Wisconsin-based biotechnology firm, Quintessence Bioscience, was moving forward on a drug similar to Alfacel’s Onconase, to treat mesothelioma. The report, from Steve Clark for WTN (Wisconsin Technology Network) News, noted that the company’s QBI-139 is very similar to Onconase, but has not been clinically tested yet.

Of course, on Monday this week, it was announced and reported here that Onconase had failed the primary objective of its late-stage trial. This news was particularly disappointing since the drug already has orphan drug status in the U.S., Europe and Australia due to the very high hopes for its success. Despite failing in its primary objective, however, testing did show that the drug is effective in a secondary effect, helping to prolong the life of those treated after standard chemotherapy has failed.

The report of Onconase’s initial failure prompted WTN’s Clark to revisit Quintessence to find out if the Onconase failure would derail the development of their QBI-139. In his new report, Clarks says he found researchers undaunted and pressing forward. He says they hope to move the drug into clinical trials sometime this summer, and they believe the success of Onconase’s secondary role and hopeful FDA approval in that area will help pave the way for general acceptance of RNase cancer therapies.

In his earlier report, Clark pointed out that QBI-139 has several differences from Onconase in the way it is produced, which he believes will make it inherently more effective than Onconase.

He points out that mesothelioma is a particularly difficult cancer to treat, and wonders if the selection of mesothelioma as a research track by Alfacell was made to help fast-track the development of the drug. Perhaps, he wonders, the drug might be more effective on “more common and easier to treat cancers than mesothelioma.”

The Mesothelioma Applied Research Foundation (MARF) will hold its International Symposium on Malignant Mesothelioma 2008 in Washington, D.C., June 26-28. The annual event highlights the latest advances in research and treatment for patients and caregivers, offers psychosocial support to them as well as those who have lost someone to the disease, and provides significant advocacy and volunteer opportunities for those who are intent on eradicating mesothelioma.

According to Rob Grayson, director of marketing for the Meso Foundation, the event actually started as a purely scientific event, geared toward researchers and scientists, with technical presentations. However, at the time, there were no informational or educational events like it, and they found that patients, families and caregivers wanted to attend.

“Initially, these people would come and sit in on these high-level presentations by scientists, with very technical presentations. We saw the interest and our meeting has now evolved into more of a patient meeting, the scientists speak in more layman’s terms, and we’ve added programs to reach out to people who are also interested in the community of support and the activism that takes place,” Grayson said.

The advocacy element is a new piece of the symposium, added last year when the meeting coincided with debate in the Senate on the Ban Asbestos in America Act, S. 742, sponsored by Senator Patty Murray (D-WA).

“The day we lobbied, they took an administrative vote, and it passed in the Senate. So we’re going back to Washington this year,” Grayson said.

Advocacy efforts this year will include a rallying cry to the House of Representatives to move quickly to pass the legislation in the House, which bans asbestos and provides research funding for mesothelioma. Last week, the Foundation issued an action alert in support of The Bruce Vento Ban Asbestos and Prevent Mesothelioma Act of 2007 (H.R. 3339), the companion to the Senate bill. The bill includes $10 million for mesothelioma research.

“Normally we’d hold the Symposium in a different city each year, but it’s almost the same timing as last year, with the bill pending, this time in the House, so we’re back to Washington,” Grayson explained.

Those attending the Symposium can register to participate in the advocacy efforts, and the Meso Foundation will arrange for them to meet personally with their congressional delegate, and will provide a training session to help advocates prepare for the meeting.

In addition to lobbying for passage of the House bill, Symposium advocates will request that the Senate’s Defense Appropriations Subcommittee maintain, for the second year, mesothelioma’s eligibility to compete for medical research funding from the Department of Defense. In 2007, the DoD appropriated $50 million and included mesothelioma as a research priority for its Peer Reviewed Medical Research Program, effective in the 2008 budget. The Meso Foundation is working for continuing and increasing funds for mesothelioma research in the 2009 defense appropriations bill.

“There currently is no ban on asbestos, so companies can use it however they see fit. We’ve pretty much stopped mining here, but asbestos is still used in about 3,000 products that you could go out and buy right now. Even if we banned asbestos tomorrow, it probably won’t change the rate of sickness for the next 50 years, due to the latency period of asbestos. That’s why the funding for research is so important,” Grayson says. “Advocacy and the call for a ban on asbestos raises awareness, and raises money for research, which is what we need to deal with the illness itself,” he said.

In addition to advocacy, the Symposium again will feature an educational program, with sessions covering topics including Peritoneal Mesothelioma, Pleural Meso Surgical Options, Emerging Therapies, Optimizing Patient Care, and Scientific Advances in Meso Research. Other educational programs will provide instruction on outreach topics including volunteerism, fundraising, peer support and advocacy, to help those who want to make a difference learn how to be most effective.

A Gala Dinner will honor those people living with meso, and recognize outstanding volunteers and advocates for their hard work and dedication to raising awareness. The dinner will feature a unique guest speaker - Seventh grader Lexi Miletto, the granddaughter of Joseph Miletto, who died in 2005 of peritoneal mesothelioma.

Scholarships for Symposium registration fees, as well as for transportation and accommodations, are still available for patients, family members and caregivers who would like to attend. Contact the Meso Foundation at www.curemeso.org or call 805-563-8400 for details.

The Mesothelioma Foundation was started in 1999, by attorney Roger Worthington. Unfortunately, Grayson says, there was an initial stigma because of his association, with people suspicious the Foundation was attempting to gather clients for his firm, so he removed himself from the Board of Directors and the Foundation was re-established as a non-profit, 501(c)3 organization. Today, with 8 staff members, the organization raises $2.5 million annually and funds more than $1 million in research projects.

“Currently, most of our funding goes to seed money to help researchers who have good ideas for treatment to validate their work, and take it to the NIH to get additional funding for the next step of the research,” Grayson explained. “We hope very soon that we’ll be able to fund clinical trials.”

In the ongoing quest for a cure for mesothelioma and other life-threatening illnesses, the debate over the validity and effectiveness of complementary and alternative medicine (CAM) continues to stir up strong emotions.

Complementary medicine is used along with standard medicine, while alternative medicine is used in place of standard treatments.

Complementary and alternative medicine may include dietary supplements, megadose vitamins, herbal preparations, special teas, acupuncture, massage therapy, magnet therapy, spiritual healing, and meditation.

Not long ago, I shared Charlene Kaforey’s good news, when she discovered her mesothelioma mass had diminished by half after completing a first round of cancer vaccines, considered an alternative treatment.

Recent news has included reports of research ranging from the effects of nonsteroidal anti-inflammatory medicines in combination with chemotherapy, to the use of Chinese mushrooms in homeopathic treatment, to a study indicating traditional chemotherapy might enhance the effectiveness of cancer vaccines, which are currently in clinical trials.

The problem, according to complementary medicine (CM) professor Edzard Ernst, in an editorial published recently in BMJ Clinical Evidence, is that “one side of the debate argues that there is no scientific evidence that can support CM, while the other side believes scientific evidence cannot be applied to CM.”

The danger, he says, is that waiting for absolute evidence might prevent someone from trying a therapy that could be beneficial, but siding with the idea that CAM simply cannot be proven may lead a patient into treatment that could cause more harm than good.

The National Cancer Institute’s Office of Complementary and Alternative Medicine (OCCAM), which coordinates the Institute’s research program in CAM, has established a goal of evaluating data from CAM practitioners with the same rigorous scientific methods employed in evaluating treatment responses with conventional medicine.

Major categories of CAM therapies, as determined by OCCAM, include alternative medical systems (built upon complete systems of theory and practice, like traditional Chinese medicine or homeopathy), energy and electromagnetic based therapies, exercise therapies (like yoga), manipulative and body-based methods, mind-body interventions (like hypnotherapy), nutritional therapeutics, pharmacological and biologic treatments (like vaccines), and spiritual therapies (healing, prayer).

OCCAM is developing the NCI Best Case Series (BCS) program based on its evaluations of CAM therapies, in which it provides an independent review of medical records and medical imaging from patients treated with unconventional cancer therapies.

But whether or not alternative and complementary medicine can be proven effective, people will still seek it out, says Professor Ernst. The “almost insatiable hunger of patients” for CM has driven its importance, he says, despite criticisms, praise or skepticism from the medical community, scientists or politicians, and in spite of the fact that more often than not health insurance does not cover the treatments.

Obviously, this topic - and its accompanying debate - needs much more examination. I will be exploring it more in the future. Do you have an experience with complementary or alternative medicine? Share it with us!

This week BBC News / Health reported on a recent study published by The Lancet, which features independent and authoritative commentary on global medicine, including research and analysis from all regions of the world. The study suggests that chemotherapy is not effective in dealing with mesothelioma, which is an asbestos-induced cancer that effects the lungs and, more rarely, the abdomen.

The results are based on a study of 409 patients, mostly from the United Kingdom, which set out to assess the potential benefits of combining active symptom control, which usually involves steroid drugs and radiotherapy, with chemotherapy. Results showed no real benefit from adding the chemotherapy drugs compared with just treating the symptoms of the disease.

The BBC quotes one of the authors of the study, Dr Richard Stephens from the Medical Research Council Clinical Trials Unit, as saying, “While thousands are and will be affected by this deadly disease, our trial, which is one of the few large trials ever conducted in this disease, emphasizes how difficult mesothelioma is to treat. This is mainly because mesothelioma forms in the lining of the lung. This makes it hard to target.”

One chemotherapy drug, vinorelbine, was shown by the study to have some promise, but researchers do not think blanket chemotherapy treatment is a promising direction for treatment of mesothelioma, according to the Lancet report.

Researchers do not necessarily consider these findings to be bad news, as a study that defines what does not help can be beneficial to patient health because it helps reduce the chance that patients will undergo stressful treatments that are ineffective.

Results of a completely different chemotherapy study conducted by researchers at Duke Comprehensive Cancer Center were released May 18, revealing that chemotherapy given in conjunction with cancer vaccines may actually boost the immune system’s response to the vaccines, according to a report by ScienceDaily.

The Duke study focused on a drug used to treat lymphoma, but could have implications for clinical trials with vaccines being used to treat many cancers including lung cancer, brain tumors and colorectal cancer.

According to the FDA, it is the goal of cancer vaccine clinical trials not to prevent cancer, but to treat existing tumors. The idea is to train the person’s immune system to recognize the living cancer cells and attack them.

In July 2007, the American Association for Cancer Research examined the issue of cancer vaccines and, according to a report by Medical News Today, they found that “ongoing therapeutic cancer vaccine trials have yet to show evidence of vaccines spurring a patient’s immune system to shrink tumors - yet patients who receive these vaccines in trials tend to live longer and respond better to subsequent treatment.”

The full study, titled Cancer Vaccines: Moving Beyond Current Paradigms is available to read online at Clinical Cancer Research.

Full results of the Duke study will be presented May 31 at the American Society of Clinical Oncology meeting in Chicago, Ill.

Probably the most important mission of myMeso.org is to give you – people affected by mesothelioma, other asbestos-related diseases, and lung cancer – a place to tell your story. Whether you are personally struggling with the disease, or are helping a loved one or friend face this diagnosis, we want to provide a forum where you can share what you are going through.

To help you do this, and to help other visitors to myMeso.org find your story, we’ve added a new Meso Map feature. The Map is interactive, and will have markers showing where different people affected by mesothelioma, asbestos disease or lung cancer are located in the United States or around the world. Click on any marker on the map to read their personal story.

On the Map page, you can also access a form that makes it easy for you to submit your own story. You can share as little or as much personal information as is comfortable for you.

The Map can be easily found on the myMeso.org home page, at the top right - just look for the map with the words “Help Raise Awareness.” Or, visit this page directly by copying the link: http://www.mymeso.org/mesothelioma-stories-share-your-story and pasting it into your web browser.

Personal stories are SO important.

Telling your story may give you the outlet you need, to express the frustrations, joy, fear, successes, and anger - the whole range of emotions you experience.

Your story may provide guidance, comfort and a sense of community for people who are facing similar challenges. You may provide just the information about new clinical trials, about your experience with different treatment options, or an outstanding support group that is just what someone else is looking for.

Most of all, sharing your story will help us to put a human face on mesothelioma, which is critical to sparking action to fund research and find a cure.

Whatever you want to say, we’re ready to listen.

So please, visit our Meso Map page to read stories from mesothelioma and lung cancer survivors, and share your story!

I recently posted about the progress of a new drug to treat mesothelioma, called ONCONASE, which has completed Phase IIIb clinical trials and is being fast-tracked for approval in the U.S. ONCONASE already has orphan-drug status in the EU and Australia.

This week, I found a story that provides even more hope. It seems a Madison, Wisconsin-based biotech firm, Quintessence Bioscience, also has a promising mesothelioma drug in the works that operates along the same lines as ONCONASE, tagged QBI-139. The Quintessence drug is not yet in clinical trials.

Both drugs target RNA in cancer cells. They are therapeutic ribonucleases (RNases), which WTN News (Wisconsin Technology News) writer Steve Clark describes as “ubiquitous enzymes that destroy RNA.” He explains that researchers including the University of Wisconsin-Madison’s Ronald Raines, “discovered that RNases from non-human species sometimes are not regulated inside human cells and can cause cell death. Surprisingly, cancer cells are much more susceptible than normal cells to foreign RNases.”

The ONCONASE product is made from purified frog eggs. The Quintessence drug is 95 percent human, but still kills human cancer cells, Clark reports. Both drugs can kill a wide range of different human cancer types, he says, so its application has broad potential. The ONCONASE clinical trial data is from patients with malignant mesothelioma.

Clark reports that Quintessence is optimistic about its QBI-139 surpassing the positive results of ONCONASE. He says that frog-derived ONCONASE has been shown to cause allergic reactions in some patients, which would be mitigated in the 95 percent human-gene QBI-139. Additionally, he reports QBI-139 is less toxic than ONCONASE, which will allow it to be better tolerated by some patients in larger doses.

Currently, Clark reports, QBI-139 is being produced for use in a Phase I clinical trial, which is set to begin this summer and end sometime in 2009. It is anticipated that the trial will be held at the University of Wisconsin Carbone Cancer Center.

Read the full article at WTN News.

Steve Clark, Ph.D., is a former professor and medical researcher at the University of Wisconsin School of Medicine and Public Health, and is currently a freelance writer and consultant on biotechnology issues.

About 5 minutes into Linda Garmon’s documentary about cancer, titled The Truth About Cancer, which aired last night on PBS on Alabama Public Television, I started crying. I was a mess through most of it. Garmon films her husband, Larry D’Onofrio, who is diagnosed with mesothelioma, and records his journey. Within two years, he has died.

About six years after his death, Garmon revisits some of the cancer centers where Larry was treated, and talks to doctors, patients and family members of those suffering from a variety of cancers - pancreatic, lung, breast, prostate.

The documentary explores the complicated maze of cancer treatment, which is so widely varied partly due to the many variations cancer takes within the human body as it mutates genes. It also looks at how cancer affects people’s relationships, with the person battling cancer oftentimes also feeling the pressure to “beat it,” to “win” over cancer, a feeling of pressure that it’s somehow up to them to get well.

Garmon touches on the issue - why are people still dying of cancer? She shows news footage of President Richard Nixon declaring war on cancer. And here we are still fighting.

Larry D’Onofrio built his family’s home, and worked on other construction projects. It is suspected he contracted mesothelioma as a result of asbestos exposure in that work. Garmon wonders, “why him?” when others who worked alongside him are healthy today.

I write about mesothelioma every day because it’s my job. But I’m touched by the people I meet who share their stories. I’m amazed by the patients who agree to clinical trials even when they understand that there probably won’t be a miracle cure for them, but because they understand that by doing so they might help someone after them.

And I’m touched by the people affected by mesothelioma who work for awareness. To reach out from their place of pain to try to bring the issue to light - that’s strength almost unimaginable. Thank you, Linda, for having the strength to share your story, the story of you and Larry and the hardest battle you ever had to fight.

PBS will air the documentary several more times in the coming weeks. If you missed it last night, I urge you to check your local listings and make a point to see it. It’s powerful, and it’s a message more people need to hear.

Personal assistance to those with lung cancer

In addition to its lobbying efforts, the other main focus of the Lung Cancer Alliance is to provide care and counseling to patients diagnosed with lung cancer. A big part of this is to help patients find clinical trials for new medications.

“Right now, there are only about three, maybe four, drugs that are approved for treating lung cancer,” explains Rear Admiral Phil Coady, U.S. Navy (Ret.), chairman of the board for the LCA. “Once you get past that, you’re on your own and there’s nothing else.”

The next step can be participation in a clinical trial testing new cancer-fighting drugs. The LCA has a screening process to help patients find a trial that fits their situation.

“It’s bewildering trying to figure out what’s a good trial for you and what you’re eligible for,” Coady said. “We ask patients questions about their progression, what they are willing to do, where they live, lots of other questions, and then we can process that information against a database of ongoing clinical trials and match a patient to where they are a good fit. It gives them another avenue to try something else, to keep hoping.”

They also provide patient support services like the Phone Buddy program, a peer-to-peer support network for people with lung cancer and their family members and caregivers, as well as an online forum where lung cancer survivors and their families can network with other people who are struggling with the illness.

Finally, LCA strives simply to raise awareness about lung cancer, and to promote early screening.

“Our goal is to save lives. Simple as that,” Coady said.

For more information about LCA and its programs, visit www.lungcanceralliance.org or call the Lung Cancer Information Line at 800-298-2436. Tap into the LCA Survivors Community online at http://lungcancer.clinicahealth.com. Call the Phone Buddy program at 800-298-2436.