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