Posts Tagged ‘clinical trials’

Complementary, alternative medicine debate

28 May 2008 by Wendi Lewis under News, Research/Treatment

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!


Mesothelioma and chemotherapy research

19 May 2008 by Wendi Lewis under News, Research/Treatment

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.


Meso Map puts a human face on mesothelioma

25 Apr 2008 by Wendi Lewis under People

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 .” 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!


New mesothelioma drug being developed

21 Apr 2008 by Wendi Lewis under Research/Treatment

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. 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 , 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 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 clinical trial data is from patients with malignant mesothelioma.

Clark reports that Quintessence is optimistic about its QBI-139 surpassing the positive results of . He says that frog-derived 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 , 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.


The Truth About Cancer

17 Apr 2008 by Wendi Lewis under News, People

About 5 minutes into Linda Garmon’s documentary about cancer, titled The Truth About Cancer, which aired last night on PBS on 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 . 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.


LCA lobbies – Part 3 – Personal Assistance

27 Mar 2008 by Wendi Lewis under Organizations, People

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. (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 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.


MESORFA supports Veglin trials

18 Mar 2008 by Wendi Lewis under Organizations, Research/Treatment

mesorfa logo.thumbnail MESORFA supports Veglin trialsThe Mesothelioma Research Foundation of America is supporting clinical trials of Veglin, a relatively new anti-angiogenesis drug designed to halt blood vessel formation. Anti-angiogenesis drugs target the body’s natural production of Vascular Endothelial Growth Factors (VEGF), proteins that spark blood vessel growth into cancerous tumors and lead to malignancy. Mesothelioma is among the cancers being studied in the clinical trials.

Veglin is undergoing clinical trials at the University of Southern ’s Keck School of Medicine, and, in August 2007, MESORFA teamed up with doctors at the Yale Cancer Medical Center in an endeavor to meet the needs of the mesothelioma patients on the East Coast.

Veglin inhibits VEGF proteins, halting the formation of blood vessels and limiting the ability of tumors to grow and spread. Veglin is an antisense oligonucleotide, meaning that it can bond to messenger RNA (nucleic acid that directs protein production) and block the production of VEGF proteins.

Trials are targeting patients that have already undergone chemotherapy, and also newly diagnosed patients.

To determine if you qualify for Veglin, please contact Jennifer Paul, Executive Director, by calling 1-800-909-MESO (6376).


Australian company advances anti-cancer drug

14 Mar 2008 by Wendi Lewis under Research/Treatment

A Melbourne, Australia-based drug manufacturer, Cytopia Limited, is proceeding to the next phases of testing in clinical studies for its anti-cancer compound, CYT997.

The vascular disrupting agent (VDA) is under investigation in treating specific types of cancer with high unmet medical need and poor prognosis. Mesothelioma is included in the study, and is entering Phase II clinical trials.

The company reports favorable findings in mesothelioma patients in a Phase I trial. Based on these results, Cytopia is beginning feasibility analysis for a Phase II study in mesothelioma patients who have failed the currently approved drug, Alimta (pemetrexed).

The single-arm study will include 20-30 patients in Australia, the United States and Asia. The company hopes that activity in second-line mesothelioma could lead to expedited drug approval and a fast to-market strategy for the compound in this cancer indication. They expect to file reports on this study in the third quarter of 2008.

Cytopia, Ltd., is an Australian biotechnology company focused on the discovery and development of new drugs to treat cancer.


Study may lead to early Meso diagnosis

4 Mar 2008 by Wendi Lewis under Research/Treatment

Clinical Cancer Research, a publication of the American Association for Cancer Research, recently released the results of a study from Japan, in which researchers examined the potential of establishing a tumor marker to aid in screening for early diagnosis of mesothelioma.

The study was based on the fact that because mesothelioma initially progresses on the surface of the pleura and peritoneum without forming masses, it has been difficult to diagnose at an early stage, so it would be useful to identify a tumor marker that would help in identifying it.

Researchers had previously identified N-ERC/mesothelin as a potential biomarker for mesothelioma. The recent study used a newly developed ELISA (enzyme-linked immunosorbent assay) system to gather data in clinical trials.

The report states that 102 healthy volunteers were recruited for the study, as well 39 patients diagnosed with mesothelioma, 53 patients diagnosed with diseases that should be distinguished from mesothelioma, and 201 subjects diagnosed with asbestos-related nonmalignant diseases.

The findings show that N-ERC/mesothelin is a very promising tumor marker for mesothelioma, especially epithelioid mesothelioma.” Serum N-ERC/mesothelin levels showed that the median values from patients with mesothelioma were extremely high compared with levels from other patients.

Researchers participating in the study represented Juntendo University School of Medicine, National Organization Tokyo Hospital, Fukujuji Hospital, Hirano Kameido Himawari Clinic, Immuno-Biological Laboratories Co., Ltd., Hyogo Prefectural Tsukaguchi Hospital, Yokosuka Kyosai Hospital, St. Marianna University School of Medicine, and Tohoku University Hospital.


Mesothelioma Treatment Options

27 Feb 2008 by Scott Thomas under

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