How to keep track of the latest clinical trials that one may be eligible for

The single most complete resource for clinical trials in cancer is offered through the NCI at www.cancer.gov.  Clinical Trials are listed under the Clinical Trials and the Find a Clinical Trial tab on the www.cancer.gov website.  Detailed instructions on how to use this search tool are available on the website.  We also provide a discussion of that in our book, Cancer Clinical Trials.  Once you set up a search that fits your specific situation, there is an easy way to track the latest trials.  The trial status component of the search form allows you to check the new trials box. This will show you only trials added in the last 30 days. This feature is very helpful if you want to track any new trials that are activated without going through the entire list every time.  A useful strategy is to do a thorough search for clinical trials once and then repeat the same search with the new trials box checked every 30 days.  This way, one can be sure not to miss anything new. 

For more questions and answers about clinical trials, visit the Talk about Health website.
To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Clinical Trials—a brief history

Over the past few decades clinical trials have been in the news quite frequently. Every time an important new drug has been approved or disapproved you hear about it on TV, read about it on the Internet, or hear about it from your medical team.

But did you know that the first successful clinical trial we know about occurred more than 250 years ago? If you have read our book, Cancer Clinical Trials, of course you do but if you haven’t you may find this interesting.

For hundreds of years, sailing ships explored the world on longer and longer voyages (think Columbus, Cook, Magellan, etc.). While on these long voyages, many sailors became ill with scurvy—a disease that causes severe joint pain, loss of teeth, skin lesions, bleeding ulcers, and even death. Nobody knew for sure what caused this.

In the 1740s a Scottish doctor named James Lind was hired as a ship’s doctor and while on a long voyage observed the devastating effects of scurvy. He believed it was diet-based and devised a plan to test his idea. His hypothesis was that scurvy was diet based and lemons and lemon juice might cure it. The experiment was to give various groups of sailors with scurvy different dietary treatments including lemon juice. After a few weeks the sailors taking lemon juice were cured and the other groups were not. The result was that Dr. Lind had shown scientifically that lemon juice would cure scurvy. We now know that scurvy is caused by a vitamin C deficiency and lemons and limes can prevent or cure it.

It took a long time for Lind’s discovery to be widely accepted, but eventually and to this day citrus fruits and juice are available on nearly all voyages and scurvy is no longer the scourge of the seas.

This is the same process (hypothesis, experiment, result) used to conduct clinical trials today—with a little more sophistication, of course. We owe a debt of gratitude to Dr. Lind.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Children and Cancer Clinical Trials

Cancer in children and teenagers is relatively rare, making up only about 1 percent of all cancer cases in the U.S. But according to the National Cancer Institute, that still means more than 12,000 children in the U.S. under the age of 15 will be diagnosed with cancer this year. Cancer is the second leading cause of death for children—after accidental injuries. During the past 20 years, the childhood cancer 5-year survival rate has dramatically increased from 60 percent to more than 80 percent.

                              

Childhood cancers are usually quite different from adult cancers. They often form in parts of the body that are still growing and changing, such as the blood system, brain, nervous system, and kidneys. There is no known cause for most childhood cancers. Leukemias (blood cell cancers) and cancers of the brain and central nervous system account for more than half of all childhood cancers. Pediatric (childhood) cancers tend to be more aggressive than adult cancers.

In stark contrast to adult participation in clinical trials (less than 5 percent) well over half of all children with cancer participate in clinical trials. Improvements in treatment developed in clinical trials account for the rapid improvement in survival rates.  Today, 80% of kids with cancer survive for at least 5 years.  Cancer deaths in kids have been cut in half in the last 3 decades. 

According to ASCO, the American Society of Clinical Oncology, many pediatric clinical trials are focused on new treatments, evaluating whether a new treatment is safe, effective, and possibly better than the current (standard) treatment. These types of studies evaluate new drugs, different combinations of existing treatments, new approaches to radiation therapy or surgery, and new methods of treatment. Researchers also focus on easing symptoms, reducing toxic side effects, and reducing side effects that may occur after treatment has been completed. 

Clinical trials have made a major contribution to the many advances in treating childhood cancer.

To put a smile on your face see Larry's latest cartoon


(c) 2012 Tom Beer and Larry Axmaker

Do physicians stand in the way of patient participation in clinical trials?

We've talked a bit about things that keep patients from choosing to participate in cancer clinical trials, but what about their doctors?  Well, there are barriers on the physician side to.  In an article recently published in Oncology Times, I review some of these barriers and offer a bit of a call to arms to the oncology community. 

According to the NCI, physician barriers include: lack of awareness of appropriate clinical trials, unwillingness to “lose control” of a patient’s care, belief that standard therapy is best, belief that referring and/or participating in a clinical trial adds an administrative burden, and concerns about the person’s care or how the person will react to the suggestion of clinical trial participation.  To learn more about it, take a look at the article in Oncology Times.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Why don’t THEY (people with cancer) join a clinical trial?

 …so I can get cured

I’m sure (pretty sure) that everyone with cancer wants to be cured. Or at the very least to have their cancer stopped from growing. I sure do.

At the same time, the vast majority of adults with cancer do not to participate in clinical trials—the way new drugs are tested and ultimately approved and made available to you and me.

What’s wrong with this picture? We seem to live in a culture of “let somebody else do it.”

·        If only the government would…

·        THEY should improve education…

·        My doctor should make me feel better…

In the realm of cancer clinical trials, having cancer is usually a prerequisite to participation. There are 12 million of us in the U.S. living with cancer. Yet, many clinical trials are delayed or are never even started because not enough of THEM (people with cancer) volunteer to participate.

Not everyone with cancer is a good candidate for a clinical trial. But many thousands who might be good candidates never hear about clinical trials or may not seriously consider the possibility of volunteering. Fortunately, many thousands do volunteer and many trials are successfully completed.

Where do you stand? Could there be a clinical trial in your future? Should there be?

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker

US health care costs: where are we getting our money's worth

A recent article on the PBS website by Jason Kane provides a thorough and thoughtful discussion on US health care costs and how they compare to other countries.  

We spend considerably more on healthcare than everyone else, including other rich countries, and in most areas we do not seem to get our money's worth.  Our health and our longevity are no better than others who spend much less.  In many areas of medicine, we do more procedures and more tests than the rest of the world, but don't seem to get better results.

So are there any areas where we do get some bang for our buck?

Yes there are.  The author points out that cancer outcomes are better in the US than anywhere else and these are important outcomes, like survival!  The other area where we lead the world in is medical research.  There are currently 119,469 clinical trials underway in the United States, far more than any other country.  In addition to that, new drugs and devices get approved faster in the US than most other places.  Yes, you heard that right. 

We need to get better value for the health care dollars that we spend, but it's great to know that there is one area where we appear to get our money's worth and that is cancer care.  

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Cancer Clinical Trials – minorities and the elderly missing in action

An article in the November 2011 issue of CancerDiscovery, the journal of the American Association for Cancer Research, defines the problems and outlines strategies for recruiting minority groups and seniors for Clinical Trials.

Although about one third of the US population belongs to a minority group, this group accounts for less than 1 percent of adults enrolled in clinical trials. And, while nearly half of those diagnosed with cancer and 65 or older, seniors make up only 25% of clinical trial participants.

Minority groups and the elderly are at higher risk of being diagnosed with cancer than the population as a whole. So when there is low participation in trials from any group of cancer patients, the trial results may not be as applicable to those groups. And the low participation can also delay final approval of beneficial drugs. In order for us to know how to best treat all Americans with cancer, we need all Americans to be represented in clinical trials.

Several groups are now focusing on providing basic clinical trial education using DVDs to these groups—in several languages when appropriate.

Another direction is to provide additional training to nurses and doctors to help them better understand the issues in recruiting and the possibilities of participation in clinical trials for their patients.

And in some locations patient ‘navigators’ are being trained to provide one on one information, answer questions, and help potential participants fill out application materials.

A prostate cancer Dream Team—new hope for men with advanced prostate cancer

 StandUp To Cancer (SU2C) and the Prostate Cancer Foundation have combined resources to fund a Dream Team of Oncologists/Scientists to study personalized treatment for advanced prostate cancer. The three-year project will receive up to 10 million dollars from the sponsoring organizations.

Six doctor/scientists were chosen to work together to identify resistance pathways in advanced prostate cancer and find better treatments. Four campuses of the University of California (San Francisco, Los Angeles, Santa Cruz, and Davis), the University of British Columbia, and the Oregon Health and Science University are involved. This is exciting to me (Larry) as I enter my 10th year with with prostate cancer.

Dr. Tomasz Beer, Deputy Director of the Knight Cancer Institute at OHSU and my oncologist, co-author, and friend, is one of six top scientists picked for the project. Dr. Eric J Small and Dr. Owen N. Witte have been chosen to co-lead the team. The full title of the project is: Targeting Adaptive Pathways in Metastatic Treatment Resistant Prostate Cancer (quite a mouthful). It will concentrate on men who have no reliable treatment options. Current standard treatments to lower testosterone levels often don’t work or stop working in men with advanced prostate cancer.

In the U.S. a man is diagnosed with prostate cancer every 2 minutes and someone dies from prostate cancer every 18 minutes.

According to the Knight Cancer Institute:

Treatment of patients diagnosed with hormone-dependent prostate cancer includes chemical or surgical castration, using drugs or surgery to reduce androgen hormones such as testosterone and dihydrotestosterone. However, as with most hormone-dependent tumors, prostate cancer becomes resistant to this therapy. These resistant tumors are referred to as treatment-resistant prostate cancer or TRPC.

This new Stand Up To Cancer Dream Team will explore the idea that resistance is a result of the prostate cancer cells using common cellular responses, called adaptive pathways, to escape current therapies. The team believes that by identifying these pathways and inhibiting them, they will be able to overcome treatment resistance and profoundly improve survival and quality of life for these patients.

To test their idea, Small, Witte, Beer and their colleagues will systematically subject patient biopsies (fixed, frozen and fresh tissue) and blood samples to a comprehensive molecular assessment and pathway-based analysis to determine the activity level of known and novel pathways. Once the pathways activated in TRPC tumors are identified, the Dream Team will devise co-targeting approaches in the laboratory. After validation they will test novel therapeutic combinations that co-target adaptive pathways associated with resistance. By combining established therapies with new treatments that co-target adaptive pathways, the Dream Team hopes to dramatically improve outcomes for men with advanced prostate cancer.

The long-term goal of the project is to improve outcomes for men with advanced prostate cancer (including me and possibly you). This would include increased length of life, reduced side effects, and a better quality of life. Clinical trials are scheduled to begin in 2013.

To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.

(c) 2012 Tom Beer and Larry Axmaker

Some Vaccines Have Been Approved to Prevent Cancer-Causing Infections

Several cancervaccines are currently in use and many, many more are in the experimental stage in clinical trials. Cancer vaccines boost the body’s natural ability to protect itself through the immune system.

The U.S. Food and Drug Administration (FDA) has approved two types of preventive cancer vaccines. One vaccine was designed to prevent Hepatitis B (which can lead to liver cancer) and another to prevent human papillomavirus types 16 and 18 (HPV) infection and effectively prevents about 70 percent of cervical cancer.

And just recently (2010) the FDA approved a vaccine designed to treat (as opposed to prevent) metastatic prostate cancer in men. It has been used successfully to lengthen survival. Named sipuleucel-T (Provenge®), it is individualized to each patient by using immune cells from the patient’s body.

Cancer vaccines may lead to major improvements in cancer treatment in the future. Some studies to date have shown positive results and some have not.

If you are interested in clinical trials for cancer vaccines, check out the list offered on the NCI Factsheet on Cancer Vaccines.

Taking stock - how are we doing on the cancer clinical trials blog

Recently, we got a nice review from the Journal of Clinical Research Best Practices and got selected for their "Bookshelf."  It's not the first nice review, but the first one in a little while after the initial reviews that come at the time of publication. Seeing this review got me thinking that it might be a good time to take stock of how we are doing.   In short, pretty well.  Our blog has been up and running since the beginning of the year and our book was published in May.  The book has been doing well with total sales approaching 10,000 copies.  Several partners have purchased the book in quantity to distribute to cancer patients as an educational resource.  In addition to that, regular folks are buying the books at bookstores at a good clip.  Our hope for the book was not to necessarily sell a lot of copies right away, but to establish the book as the go to resource for folks interested in clinical trials, a resource that will be an enduring one for years to come.  Time will tell, but we are off to a good start.

The blog recently crossed 20,000 page views.  A blip when compared to the giants, but a pretty good showing for us.  The most popular part of the blog...by a mile...Larry's cartoons.

Recently we launched a new effort.  It's a little ways away from being realized, but we are working on a pediatric version of our book.  It won't really be a kids book, but more a book for parents of kids with cancer.  Clinical trials are a part of cancer care for nearly 2/3 of kids diagnosed with the disease.  The principles are similar, but many things are a little different.  Not a lot of kids insured by Medicare, for example...  We are fortunate to have recruited Dr. Stacy Nicholson, Physician-in-chief at the Doernbecher Childrens' Hospital to help us refashion our book for the world of pediatric oncology.
So thank you for visiting our blog, considering our book and being a part of our community, focused on sharing knowledge about cancer clinical trials.


To put a smile on your face see Larry's latest cartoon.
To learn more about clinical trials, take a look at our book.
(c) 2012 Tom Beer and Larry Axmaker