Louisiana’s largest cancer center enters clinical research breakthrough phase

Recently, Mary Bird Perkins Cancer Center announced the expansion of its robust clinical research program to include phase 1 trials – providing a new level of care for patients close to home. Moving forward, the Cancer Center’s phase 1 offerings will continue to grow based on the needs of the patient population. Victor Lin, MD, PhD, medical director, clinical research, details how phase 1 trials differ from other trials already available and what it means for the future of cancer care in the capital region.

What are phase 1 clinical trials?

Phase 1 clinical trials represent an early stage of drug development where new treatments or treatment combinations are evaluated in patients to make sure they are safe for use. They are done after preclinical studies (sometimes referred to as phase 0 studies) involving cell and animal models to be as certain as possible that it is safe to administer these agents to patients in a phase 1 trial. Patients are monitored very closely to identify any potential adverse effects and to determine how the drug is processed by the body. After phase 1 trials have established the safety of a new treatment, phase 2 and 3 trials are done to prove that these new treatments are effective.

How is Mary Bird Perkins leading the way when it comes to access to phase 1 trials?

In the state of Louisiana, there is exceptionally limited access to phase 1 trials, so patients often need to go out of state to participate. Because patients are usually asked to come back frequently to the study site for evaluation (up to several times a week), they must often live nearby. If patients from Louisiana are traveling out of state for a phase 1 trial, this may mean that they have to move away to participate, forcing them to make a difficult choice between moving away from loved ones to pursue another treatment versus staying home and forgoing more treatment. We think it is very important to make more opportunities available to patients right here at home, allowing them to continue treatment in a comfortable setting with their support systems nearby.

How does Mary Bird Perkins evaluate which phase 1 clinical trials to offer?

Because each trial is different, I personally evaluate each protocol in consultation with other Cancer Center physicians to make sure the concept is likely to benefit our patient population. I also consider how much is being asked of the patient and whether or not that is reasonable. For instance, how many times do they have to come back for visits? Do they have to undergo additional biopsies or other procedures? Most importantly, we only open trials that I would be willing to enroll myself or my loved ones in. If I’m not sure about that, then I can’t in good conscience ask my patients to participate.

Who can be eligible for a phase 1 clinical trial?

It depends on each specific clinical trial. Because these trials are designed to prove safety, they usually have strict criteria that exclude patients with too many or severe medical problems that will interfere with the safety assessment. Each trial is also typically restricted to very specific types and stages of cancer. The best thing to do is to ask your doctor if a clinical trial is appropriate and available for you.

What is the patient financial impact of a phase 1 clinical trial?

Patients who elect to participate in a phase 1 clinical trial should have little to no additional financial burden on them. Trial sponsors generally pay for the extra visits, lab work and imaging so that insurance is not billed. Many trials also have built-in support mechanisms to cover other sources of financial toxicity, such as travel and lodging. Our clinical trials infrastructure is also supported heavily by the community.