A clinical trial for patients with malignant mesothelioma is currently recruiting participants. The trial is sponsored by Papworth Hospital in the UK, although it is open to any mesothelioma patient that meets the criteria. This study will evaluate video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.

According to information on ClinicalTrials.gov, a service of the U.S. National Institutes of Health, this is a randomized phase III trial. Video-assisted surgery removes part of the tissue layer covering the inside of the chest cavity, which researchers think may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not known at this time which thereapy is more effective.

The primary objective of this study, as stated in the project outline, is to compare the effectiveness of these two modes of treatment in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma.

Secondary goals of the study include comparing the control of pleural effusion, comparing procedure-related complications, comparing symptoms and quality of life of these patients at 3, 6 and 12 months after treatment, comparing the length of hospital stay, the exercise tolerance level of these patients at 3, 6 and 12 months after treatment, and to determine the cost to the health service, in terms of resources used for procedures, hospital bed usage and cost of primary and secondary care over 12 months.

Recruiting locations in the UK are Basildon University Hospital, Gelnfield Hospital (Leicester), Guy’s Hospital (London), Papworth Hospital (Cambridge) and Royal Hallamshire Hospital (Sheffield). Principal investigator for the study is Robert Winter, MD, Papworth Hospital.

This study is identified in the U.S. at clinicaltrials.gov by ID number NCT00821860.

For contact and recruiting information, visit the Clinical Trials information page at http://clinicaltrials.gov/ct2/show/study/NCT00821860.

The National Cancer Institute (NCI) Cancer Bulletin on July 14 featured a new clinical trial for a combination immunotoxin and chemotherapy regimen to treat pleural mesothelioma. This is a Phase I Study of SS1 (dsFv)-PE38 Immunotoxin in combination with Pemetrexed Disodium and Cisplatin in patients with unresectable malignant epithelial pleural mesothelioma (NCI-08-C-0026).

The principal investigator for the studay is Dr. Raffit Hassan of the NCI Center for Cancer Research.

According to the NCI bulletin, researchers hope an experimental immunotoxin called SS1 (dsFv)-PE38 (or SS1P) can improve the outcome of patients with unresectable (or inoperable) mesothelioma. Clincial trial information says that SS1P is a “genetically engineered biological agent in which part of a bacterial toxin is linked to an antibody that recognizes the protein mesothelin.”

Mesothelin is the protein found on the surface of epithelial mesothelioma cells and other types of cancer cells. It is hoped that combining SS1P with chemotherapy will lead to increased antitumor activity, as compared with either treatment alone.

“Given the marked synergy between SS1P and chemotherapy in preclinical studies, combining them could potentially result in increased antitumor activity in patients,” Dr. Hassan is quoted in the Bulletin.

For more information, see the Entry Criteria.

Find trial contact information online or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll-free and confidential.

I reported last week that Debbie Brewer, our friend in the UK, had another amazing report from Germany, where she has been undergoing chemoembolization to treat her mesothelioma. Her tumor has now shrunk a total of 83 percent! Debbie is sharing her experience with media in Britain, hoping to gain more widespread acceptance of chemoembolization as a treatment for meso, and to raise awareness that the therapy, currently in clinical trials, exists.

Debbie was diagnosed with mesothelioma in November 2006, at which time her doctor gave her only a few months to live. That was when Debbie began looking for new treatments. She began chemoembolization in May 2008.

Chemoembolization, which is being pioneered by Dr. Thomas J. Vogl at J.W. Goethe University Hospital at Frankfurt University, introduces chemotherapy directly into a tumor, where it is basically sealed off so that it is concentrated in the area of need. The clinical trial started three years ago, and will continue for about two more years. The treatment is only available at the clinic in Germany.

Recently, BBC News featured Debbie and her efforts to bring chemoembolization to the UK, and beyond.

Watch the video.

Today I heard from Debbie Brewer, our friend in the UK. She is just returned from another visit to Dr. Thomas Vogl in Germany, where she had wonderful success with the clinical trial for chemoembolization. She first visited Vogl for the treatment in May 2008. In March 2009, she found that her tumor had shrunk an amazing 73 percent since her first treatment. This week, she reports that even Dr. Vogl was surprised to see that Theo – as she nicknamed the tumor – had shrunk an additional 10 percent! That’s a total reduction of 83 PERCENT for those of you keeping score!

This is truly wonderful and amazing news, particularly for a cancer like mesothelioma, which has no known cure. This sounds pretty darn close for Debbie, who is considered in remission with this amount of tumor gone.

Those who have been following Debbie’s story and have read the Q&A with Dr. Vogl we posted on this site know that chemoembolization is a procedure currently in clinical trials. The process involves introducing chemotherapy directly to the tumor, and basically trapping it there, concentrating it where it is most needed. Dr. Vogl is head of the Department of Diagnostic and Interventional Radiology at J.W. Goethe University Hospital at Frankfurt University.

The clinical trial is currently treating between 300 and 400 patients with primary and secondary lung cancer annually, and about 20 mesothelioma patients.

For more information, see the Q&A with Dr. Vogl.

Read more of Debbie’s story at her blog, Mesothelioma & Me.

I know a lot of people who follow this blog are excited about the wonderful results our friend Debbie Brewer has experienced as a result of her participation in a chemoembolization trial in Germany, with her tumor shrinking 53 percent, and now essentially “dead.” The trial is spearheaded by Dr. Thomas J. Vogl, who is head of the Department of Diagnostic and Interventional Radiology at J.W. Goethe University Hospital at Frankfurt University. He has developed the clinical trial to use chemoembolization to treat mesothelioma.

Because there is so much interest in this clinical trial, even though it is currently only available in Germany, I contacted Dr. Vogl to see if he could provide a little more information about the program.

Q: Explain the basic procedure of chemoembolization / locoregional therapy in the treatment of cancer. How does it work?

A: The basic principle of chemoembolization/locoregional therapy is to achieve a transarterial approach to the tumorous lesion. In the treatment of mesothelioma we have to find the direct supply to the cancer. Then the chemoembolization material can be selectively inserted directly to the lesion. A concentration of cytotoxic drugs of up to 20 times higher can be achieved compared to systemic chemotherapy with reduced adverse events. By cutting off the vascular supply, chemotherapy can be retained in the affected region for several weeks.

Q: How did you learn that this treatment is effective for mesothelioma?

A: During treatment of patients with primary and secondary lung cancer we learned that locoregional therapies are effective for the treatment of mesothelioma.

Q: When did this clinical trial begin? (or how long has it been going on?)

A: The clinical trial started three years ago and will be continued for the next two years.

Q: What are the goals of the clinical trial for this treatment?

A: The goals of the clinical trial are to improve local tumor control, to reduce clinical symptoms like breathing problems and pain, and to increase survival.

Q: How many people with mesothelioma are you currently treating in this clinical trial?

A: Currently we treat 300 to 400 patients with primary and secondary lung cancer per year, and we treat about 20 patients with mesotheliomas.

Q: What are the general / overall results you are seeing in the trials?

A: Clinical symptoms and clinical status of the patients have improved. Local tumor control has improved as well.

Q: What is involved in evaluating a person to see if they are a good candidate for this type of treatment? (What is a good candidate?)

A: Normally we need the following material from the patient before treatment: histology of the cancer, therapy protocols so far obtained, images showing the extension of the tumor. A patient with a localized pleuromesothelioma in one half of the chest is a good candidate.

Q: Explain the procedure for someone receiving this treatment – what happens during a typical treatment visit? How long does it take?

A: After local anesthesia, the femoral vein, which is located in the inguinal region, is punctured. Then a small femoral sheath is usually inserted in the vein through which different catheters can be inserted. After displaying the caval vein, a catheter is pushed forward into the tumor feeding vessels after trespassing the pulmonary arteries. For preventing pain analgetic drugs are administered. Then the chemoembolization as well as the embolizing material are applied. Towards the end of the procedure, the catheters and the sheath system are removed and a compression bandage is applied in order to prevent complications in the inguinal region such as hematoma. After surveillance of 6 to 24 hours, in which complications might be detected and treated, the patient will be discharged. Up to 24 hours after the procedure a CT scan is performed in order to evaluate response to treatment or complications.

Q: How often / frequently does a person receive treatment?

A: The patient normally receives the treatment three up to four times in a 1-month interval.

Q: What are typical side effects of treatment?

A: The typical side effects of the treatment are very low. Normally the patient suffers from fatigue. Nausea and an increasing shortness of breathing are also rarely observed.

Q: How would someone apply to participate in this clinical trial? (Is it still open to receive new patients?)

A: If you send me material (medical reports, MR images, CT scans) I can check it and provide a treatment plan thereafter.

If you are interested in learning more about chemoembolization, or being evaluated for possible inclusion in the clinical trial, you can contact Dr. Vogl here:

Prof. Dr. Th. J. Vogl
Department of Diagnostic and Interventional Radiology
University Hospital
Theodor-Stern-Kai 7
D-60596 Frankfurt

Email: T.Vogl@em.uni-frankfurt.de
Contact telephone number: 0049-69-6301-7277

Because of the nature of mesothelioma, and the fact that there is no known cure for it, many meso patients are particularly interested in alternative treatments or new medicines. There seems to be a willingness to try new things in an effort to find a cure, and also to help researchers learn more about mesothelioma so that they might help other people in the future. There is a government web site that can help meso patients find ongoing clinical trials that are recruiting patients.

ClinicalTrials.gov is a web site registry that provides current information about federally and privately supported clinical trials for a wide range of conditions, with trial locations all over the world. The site is searchable by condition, drug intervention, sponsor and location. The site also provides information about a trial’s purpose, who may participate, locations and phone numbers for more details. The information should be used in conjunction with advice from a patient’s health care provider.

The web site is a service of the U.S. National Institutes of Health, through its National Library of Medicine (NLM), and the U.S. Food and Drug Administration. All data and search information on the site is provided by ClinicalTrials.gov. There is no charge for the service.

A clinical trial is a controlled study that allows physicians to evaluate the effectiveness and safety of new drugs or devices. Generally, investigators enroll a small number of patients or volunteers in a clinical trial in an initial pilot program, and then they may expand the program to include more patients or specific criteria as they gather more information. Clinical trials help researchers compare new treatments against other that are already established for treating a certain condition.

Here is a link to mesothelioma studies listed in ClinicalTrials.gov.

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.”