Clinical trials are necessary to advance potential new treatments and demonstrate effectiveness. For patients who decide to participate in a clinical trial, finding the right clinical trial for them can be challenging and there is a lot information to absorb. If you are receiving care at a hospital that has a dedicated brain tumor program, it’s never too early to ask them about clinical trial participation. If not, I recommend seeking care at a major hospital with an established brain tumor treatment team or do your own research.
Let’s get to the basics and talk about Phases of Clinical Trials. Here is a general description:
Phase 1 is the earliest phase where researchers determine drug safety and proper dosage. In clinical trials for cancer patients, the researchers also look for signs of drug activity during this phase.
Phase 2 studies further evaluate the effectiveness of the treatment at a dose established in Phase 1. Studies can be designed with only the treatment group or comparing the treatment group with a group receiving standard of care treatment. Given the high unmet needs in many cancers, drugs can be initially approved based on positive Phase 2 results.
Phase 3 studies are often designed to confirm the results from Phase 2 but in a larger number of people.
Because there are many types of brain cancers and several variables within each cancer type, interpreting results from trials that allow a wide range of brain cancer patients can be challenging. Thus, clinical trials have entry criteria designed to enroll a defined group of patients so the resulting information can guide additional development. Two common entry criteria for brain cancer trials specify the type of tumor and if the patient has a newly diagnosed or recurrent tumor. If a surgical resection will be required at recurrence, consider trials that include a resection. Several trials at recurrence require that the patient has not taken Avastin as a treatment. It is important to talk to your doctor about clinical trials before being prescribed Avastin. In addition, many modern trials require genomic information about your brain tumor from the initial biopsy or resection, such as IDH1, 1p19q, MGMT methylation or EGFR status. If your hospital does not perform these tests, I recommend you talk to your doctor about getting them done.
Here are some tips on finding the right clinical trial options for you:
- Firstly, if you are not already seeing a neurooncologist, I recommend you seek an opinion from a neurooncologist. Ask him/her about clinical trial options. It’s very helpful for the doctor to know that you are interested in pursuing clinical trials so it’s never too early to talk about it.
- Also, ask about clinical trials in your vicinity at other hospitals besides your facility, so you may be able to remain close to home and your support system. Do your own homework too as your doctor may not be aware of all the local options available to you.
- Take advantage of dedicated patient advocates and support organizations who will assist you in finding the right clinical trial options for you. Here are some helpful resources:
- Accelerated Brain Cancer Cure www.abc2.org
- American Brain Tumor Association www.abta.org
- Brain Tumor Network www.braintumornetwork.org
- End Brain Cancer www.endbraincancer.org
- Musella Foundation www.virtualtrials.com
- National Brain Tumor Society www.braintumor.org
- Voices Against Brain Cancer www.voicesagainstbraincancer.org
About the Author: Mary Lovely Ph.D. RN, CNRNs