News from Illinois CancerCare

The COVID Connection to Cancer Research

The concept of medical research has been thrust into the spotlight recently with the rapid roll-out of the COVID-19 vaccine. This provides us with a great opportunity to talk about the value of clinical research for many different aspects of healthcare, including innovative cancer treatment.

Step By Step

“Is it safe?” has been one of the most common questions about the COVID-19 vaccine. That’s a legitimate question, since other medical or pharmaceutical breakthroughs often take years – or even decades.

We talked to Kirstin Shane, Senior Clinical Research Associate at ICON, where she monitors clinical trials, including the recent Pfizer/BioNTech vaccine. Prior to working at ICON, Ms. Shane was a part of the research team at Illinois CancerCare, so she has a unique and broad perspective on clinical trials.

We’ll start with an overview of the four stages of clinical trials. Under normal circumstances, the four phases outlined below are conducted one step at a time. However, in this situation, Phases I, II and III were done simultaneously to expedite the process.

The FDA (U.S. Food and Drug Administration) provides constant oversight throughout ALL steps to ensure optimal safety and evaluate effectiveness. Physicians, trial sponsors and monitors (like Ms. Shane) keep a close eye on every little detail. Although research varies within different areas of medicine, this provides a general introduction of the process:

Phase I:

Usually includes a small number of healthy volunteers (50 to 100) to determine how the drug, vaccine or treatment works in the body, identify side effects and decide how the medication should be given. In this case, the vaccine is delivered by a shot in an upper arm muscle.

Phase II:

Typically includes a slightly larger group of volunteers (100 to 300) who have the condition or patient profile for the disease that is being targeted. Researchers focus on short-term safety and effectiveness of the drug, device, vaccine or treatment ­– while professionals like Ms. Shane monitor the process.

This phase often includes a small group that receives a placebo (inactive substance) for comparison to those who receive the real treatment. [Please note that in cancer trials, a patient will only receive a placebo if there isn’t an existing standard treatment option. Otherwise, the participant will either receive standard treatment or standard treatment PLUS an additional therapy.]

Phase III:

A much larger pool of volunteers (hundreds or thousands) is needed to confirm the drug’s safety and effectiveness across a wider group. The researchers also look closely at how the drug, vaccine, device or treatment performs compared to a placebo or existing treatments.

FDA Review:

The FDA either approves or declines to approve the drug, vaccine or treatment for use by patients who meet specific criteria. The COVID-19 vaccines from Pfizer and Moderna received Emergency Use Authorization (EUA) of these vaccines.

In addition to these vaccines, you may have heard about certain therapies, such as remdesiver and COVID-19 convalescent plasma, that received EUA for treatment of those who had already contracted Coronavirus. Phase IV cannot begin until this phase is completed.

Phase IV:

After approval from the FDA, the researchers continue to study the effectiveness of the drug, device or treatment in a wide variety of patients while continuing to monitor the long-term safety and effectiveness.

You asked. We answered.

Ms. Shane answers some common questions about the approval process:

How could they learn so much about COVID so fast?

The disease was initially called the “19 novel coronavirus” and was later named coronavirus disease 2019 (abbreviated as COVID-19). The key word in this description is “novel” because it means it’s a new strain of an existing type of virus that hasn’t been seen in humans previously.

Coronaviruses have been around for a long time, so scientists were able to use previous research on coronavirus vaccines – including those for SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome). In fact, researchers have been working on to develop mRNA coronavirus vaccines since 2014, which is considered pre-trial research.

How did the trial get done so fast?

As mentioned above, the COVID-19 vaccine trial conducted by Pfizer ran Phase I, II and III simultaneously instead of consecutively. In addition, the researchers reported their findings daily so the team was working with real-time data, rather than waiting for information to be delivered at longer intervals (often one month at a time).

Why don’t other studies move that fast?

Since nearly everyone is at risk for catching COVID-19, that means there’s an extremely large pool of volunteers who met the requirements to participate. More than 45,000 volunteers have been enrolled worldwide in the Pfizer trial. In the case of oncology research – especially for rare types of cancer – there’s a limited number of potential volunteers available.

In addition to having a smaller group of potential trial volunteers for different types of cancer, currently only 3-4% of adult cancer patients participate in clinical trials. Increasing the number of patients who get involved with oncology clinical trials can expand and expedite research for new cancer treatment options.

At Illinois CancerCare, we are enrolling for clinical trials on an ongoing basis and invite you to ask your ILCC provider about your eligibility for participation. View our current trial list here.

What else contributed to the speed of approval?

Because COVID-19 quickly exploded into a pandemic without signs of slowing down, there was a heightened focus on finding a solution. That empowered researchers to get access to the massive resources needed to get the job done, including funding, staffing, materials and equipment. The “all hands on deck” approach got the job done faster.

What percentage of drugs get approved?

Researchers and the FDA are very meticulous and conscientious about which drugs, devices or treatments get approved for use in the United States. Due to the FDA’s strict requirements, less than 5% of newly developed drugs are approved to even ENTER clinical trial research with actual humans.

Should cancer patients get the vaccine?

We highly recommend you take your first available opportunity to get the vaccine. This may be from your local health department, primary care provider or hospital system. If you have cancer or are on chemotherapy, our physicians recommend that you get the COVID-19 vaccine except under certain circumstances. Click here to learn more.

Illinois CancerCare physician Gregory J. Gerstner, M.D. provides additional insight:

I have NO reservations. I had mine in December and am telling all my patients to get it. Although we sometimes caution cancer patients against vaccinations that contain a live virus, this one does not include a live virus.

We know there are DEFINITELY some long-term effects of COVID-19, in addition to the short-term effects, so vaccination is the smart path forward for both cancer patients and their caregivers.

The Potential for Cancer Patients

You may be wondering why a cancer group is sharing information about COVID-19 vaccine development. Since COVID-19 has been a highly-visible example of the power of clinical research, it gives us an opportunity to highlight how the research process can benefit patients of Illinois CancerCare.

It’s also interesting to note that mRNA is related to both the COVID-19 vaccine and immunotherapy treatment for cancer. mRNA stands for messenger RNA, which carries codes from DNA to make a protein that triggers an immune response in our bodies.

The mRNA COVID-19 vaccines differ from other vaccines such as the flu shot because these shots don’t contain any amount of the COVID-19 virus itself. Because of this, scientists were able to produce the vaccine very rapidly. Rather than having to “grow” the virus to make the vaccine, they just needed the DNA sequence (or pattern) of the COVID-19 virus.

The Pfizer vaccine uses mRNA to make a “spike” protein, which is the hallmark of the COVID-19 virus and is visible under a microscope.

After the vaccine is injected, it resides in the outer part of your cells rather than the nucleus, which means it does not alter your existing DNA (genes). It hangs out in the cytoplasm and acts as a messenger to your immune cells to say, “Hey everyone, if you see this spike that I’m showing you, get rid of it!”

This also creates something called cell memory, which enables your immune cells to “remember” that those spike proteins are bad and need to be eliminated. If mRNA can be harnessed effectively in cancer research, we may eventually see extremely effective mRNA treatments in the oncology field.

In addition to potentially helping yourself when you participate a clinical trial for cancer, you may be contributing to powerful breakthrough treatments for cancer patients throughout the world.

Our next article will build upon this clinical trial introduction to look more closely at oncology research. We’ll address three top myths about participating in a clinical cancer trial, as well as discuss important topics like informed consent and randomization. We’ll also provide a snapshot of how the Illinois CancerCare Foundation supports our efforts to conduct these important clinical trials.