What do Clinical Trial Participants Really Want?

As you probably know by now there are many reasons for conducting clinical trials—trying out new drugs, exploring new drug combinations, testing drug safety, testing drug effectiveness, identifying and managing side effects, and many more.

But for most participants in clinical trials the main reason for volunteering is much simpler—the hope of longer and better survival. Cures are rare, but if a particular new drug or treatment makes you feel better and possibly live longer (and the ever-present side effects are tolerable) none of the overall statistics, percentages, comparisons, or dosage debates matter very much. Different treatments have different effects on different people. So what works for you may not work as well for me. Having more available treatments allows for individual differences.

Just having cancer already makes you a survivor. Surviving better and longer is the personal gold standard—however that happens for you. With the help of your medical team, support group, a good computer, and your own personal motivation, look for trials that you strongly believe may provide a particular benefit to you. The final decisions are always up to you.

The majority of trial participants report that they would volunteer for another trial if it was relevant to their needs.

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


(c) 2012 Tom Beer and Larry Axmaker

Dr. Beer speaks about experimental drugs for prostate cancer

The full original program can be found at the Research to Practice website.

More Cancer Vaccines on the Horizon

We already discussed the first FDA approved cancer vaccine, Provenge^©, an individualized treatment for metastatic (late stage) prostate cancer. The Journal of the National Cancer Institute recently published an article explaining the process of developing new cancer vaccines. According to the National Cancer Institute there are currently nine phase III clinical trials and 64 phase II clinical trials testing cancer vaccines. Cancer vaccines are developed to treat cancer—they’re not preventive.

The problem in developing vaccines has been to find a way to stimulate the body’s immune system to fight cancer. Cancer cells produce antigens which in turn trigger an immune response—often too weak to kill or weaken the cancer cells. NCI researchers are studying numerous ways to make it easier for your immune system to identify and mount a stronger response to destroy cancer cells. Cancer treatment vaccines have two goals. First, they must stimulate specific immune responses against the correct target. Second, the immune response must be strong enough to overcome the barriers that cancer cells use to protect themselves.

Vaccines were first tested on patients with late stage cancer who had suppressed (weakened) immune systems. Some current trials focus on patients with earlier stage cancers and stronger immune systems. Vaccines may work better when combined with standard treatments including chemotherapy and radiation.

Are you interested in a cancer clinical trial using a cancer vaccine? Go to the NCI clinical trials database and check out your type of cancer and see what clinical trials are available. Vaccines have the added benefit of minimal toxic side effects.

Want to know more about cancer vaccines? The NCI has an extensive Cancer Vaccine Fact Sheet online.

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


(c) 2012 Tom Beer and Larry Axmaker

How Will Cancer Vaccines Work?

When you are vaccinated for smallpox, measles, or shingles your body is flooded with antigens that trigger your immune system to produce antibodies and/or to activate immune “killer cells” to fight the perceived disease threat.

When the injected antigens are a weaker version of molecules in or on a cancer cell, the body creates ‘killer T cells’ to attack the cancer cells with that molecule. The body can also create B-cells that produce antibodies to the molecule, and by extension, the cancer cell.  The activated immune cells and/or antibodies are then able to attack cancer cells in the future that have the same molecule—this could create lifelong immunity to that specific type of cancer.

Vaccines must mimic parts of the cancer cells in the body in order to be effective. And the body must be healthy enough to produce an immune response.

In 2010 the U.S. FDA approved the first-ever tumor vaccine, called Provenge (also called Sipuleucel-T), to treat prostate cancer. Numerous vaccines are now being tested. There are many types of cancer and identifying the specific makeup of each individual’s cancer cells and creating or matching a vaccine specific to that type of cancer can be time consuming and expensive. 

Practical Tips on Choosing a Clinical Trial

·       Before you search for a clinical trial that might be helpful in your situation, understand your cancer diagnosis and all of your options.

·       Talk to your oncologist about clinical trials.

·       Know that clinical trials may be an option at all stages of cancer and that different kinds of trials may be appropriate in various situations.

·       If a good standard treatment is available for your type of cancer, generally only consider clinical trials that include that standard treatment.

·       Clinical trials become a more important option when the treatments available to you are limited.

·       Phase I clinical trials that examine the newest drugs for the first time in a human being are generally appropriate to consider only when no good treatment options are available.

·       If you are considering a randomized trial, be sure you are comfortable with all of the treatment options.  You will not get to choose and neither will your doctor.

·       Make decisions about your care, including clinical trials, only after all your questions are answered and you are comfortable that you know all that you need to in order to make informed decisions.

·       Know both the potential risks and benefits of any trial you are considering.

·       Risks include missing out on another treatment, so be sure to understand all your options.

·       Know that in cancer care, we never know your outcome in advance, but in general we know less about what to expect from a clinical trial than from standard treatment.

·       If you need more information about clinical trials, consider searching for trials at cancer.gov or  visiting a research-oriented oncology center.

·       Seek the support of your family and friends as well as support groups as you steer your cancer plan.

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


(c) 2012 Tom Beer and Larry Axmaker