The Importance and Challenge of Clinical Trial Randomization in Cancer

Why are clinical trials randomized? Patients and families sometimes ask this question about the Phase 2/3 Toca 5 study. To better understand this challenging and often frustrating topic, I interviewed Asha Das, M.D., vice president of clinical development and medical affairs at Tocagen.
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Choosing the Right Brain Tumor Clinical Trial

choosing-a-clinical-trialClinical 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:

  1. 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.
  2. 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.
  3. 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:
    1. Accelerated Brain Cancer Cure www.abc2.org
    2. American Brain Tumor Association www.abta.org
    3. Brain Tumor Network www.braintumornetwork.org
    4. End Brain Cancer www.endbraincancer.org
    5. Musella Foundation www.virtualtrials.com
    6. National Brain Tumor Society www.braintumor.org
    7. Voices Against Brain Cancer www.voicesagainstbraincancer.org

About the Author: Mary Lovely Ph.D. RN, CNRNs

Lightning Striking

When lighting strikes 3 times: Mother of 3 children with brain tumors shares insights on being a caregiver

Lightning StrikingWith three children diagnosed with brain tumors in their 20’s, Catherine Stryker is a veteran caregiver and a remarkable woman. One daughter had an acoustic neuroma, Catherine’s son had an oligoastrocytoma that became a glioblastoma from which he died after a 17-year battle, and her other daughter has an anaplastic astrocytoma. In addition, Catherine works through hospitals and non-profit groups to help other caregivers learn to cope and manage through every stage of the brain tumor disease.

I recently had the opportunity to catch up with Catherine and ask her about her experiences so that she can pass along some of her knowledge and wisdom:

  1. How did it feel when you were faced with your children’s brain tumor diagnoses?
    When we found out about my first daughter’s brain tumor it was devastating. Not knowing about brain tumors, we were in shock for at least six months. Even through surgery. Then we settled back down and dealt with it. When our other children were diagnosed, we turned off all emotions so that we could stay focused on what to do
  2. How did caregiving affect your health and overall well-being?
    I was familiar with being a caregiver because it had been my profession, so I knew it was important to stay healthy in mind and body. I was very task oriented and got things done. At times I felt helpless and unable to do anything, and it resulted in bad indigestion. I reached out to my doctor and he gave me some medicine which helped. I also started taking time for myself like going to a movie, or just taking a day off from caregiving. This helped tremendously.
  3. How did you evaluate treatment options for your family members?
    I learned a major lesson: Make sure you get a second opinion at an established brain tumor center. My son was diagnosed in Santa Barbara and the neurosurgeon said he could not operate due to the tumor location. He just had radiation and no surgery. When his seizures worsened, we went to UC San Francisco, which has a team that specializes in brain tumors and it made a huge difference in our treatment course and results.Being educated provides me strength as a caregiver. When my kids were diagnosed I learned about the non-profit groups that focus on brain tumor patients and their families. I relied heavily on them for information and support. I went to conferences to learn about new research and treatments. Even as my kids are surviving, I stay active in the field and continue to learn.
  4. What are three things you have learned about being a caregiver?a. Be Patient – Following surgery, everything slows down and multitasking becomes a major challenge. I had to learn to give them one task at a time.b. Stay Positive – My kids appreciate that I never let them feel sorry for themselves. I looked for new ways for their best quality of life. Knowing fatigue would be a problem, I encouraged them to slow down, eat healthy, and take a nap. Also, I tell them to look out for signs and symptoms that don’t feel right and speak up about it right away.

    c. Don’t lock into statistics – Statistics such as “You have five years to live,” or “You will never drive again.” My youngest daughter was told she had three months to live and she is now alive for over a decade. So much for statistics!

About the Author: Mary Lovely Ph.D. RN, CNRNs

Brain Cancer and Clinical Trial Medicine Decisions

The Impact of Avastin (Bevacizumab) on Clinical Trial Eligibility

Brain Cancer and Clinical Trial Medicine DecisionsI often encounter patients and their caregivers who are unaware that receiving Avastin too early in their treatment plan can actually disqualify them from participating in many clinical trials. This causes a lot of frustration for patients who want to participate in such trials but only learn about this issue after it’s too late. Improved awareness and communication between patients and their doctors about the trade-offs with using Avastin prior to considering participation in clinical trials, can help avoid this situation.

Avastin (bevacizumab) is an approved treatment for gliomas at recurrence, and it may help some patients with brain cancer to manage symptoms related to brain swelling. However, a common and important question is when is the best time to use it?

Dr. Piccioni and co-authors from leading universities published results from a 468 patient retrospective study (Piccioni, Neurooncology 2014) that showed deferred use of Avastin didn’t negatively impact survival and was actually preferable for most patients with recurrent glioblastoma. While not a definitive study, these results indicate that patients with recurrent glioblastoma can consider participation in clinical trials first and defer use of Avastin until later, without feeling that they are losing out on its potential benefit.

If you are considering use of Avastin for recurrent brain cancer I recommend you first explore the opportunity to participate in a clinical trial and talk to your doctor about the trade-offs with using Avastin. You can also talk to one of the brain cancer foundations, or brain cancer support professionals, who could provide you with information of which trials are open, where they are located and which ones might fit your particular clinical situation.

References

About the Author: Mary Lovely Ph.D. RN, CNRNs

Nutrition for Brain Cancer Patients – Eating Better, Feeling Better, Living Better

NutritionWith so many things going on while battling a brain tumor, it’s challenging to pay attention to nutrition. To complicate things further, conventional treatments can cause some people to experience taste changes, which makes food choices and nutrition a moving target.

I am commonly asked by survivors and their caregivers if diet can be helpful in managing a brain tumor. While there is no definitive data showing that a specific diet can cure or slow the tumor, poor nutrition can impact your fitness, energy, and sense of well-being. When you focus on nutrition, you can give yourself a boost in body and in mind. Furthermore, taking charge of nutrition can be empowering because it’s an aspect of normal daily living that people can control. Eating foods that are high in protein and low in fat and sugar can raise your energy level and reduce fatigue. Some food combinations may also decrease nausea, vomiting, and constipation commonly experienced during treatment with chemotherapies, such as temozolomide. In my support group in San Francisco, we encourage people to share with the group their day-to-day experiences and how they have tackled dietary and nutrition issues. They teach me new approaches to eating every time we have this discussion.

Many excellent resources about nutrition exist including:

About the Author: Mary Lovely Ph.D. RN, CNRNs

Fatigue: A common symptom and source of frustration in the fight against brain cancer

FATIGUE-1In many studies describing the experience of high grade brain tumor survivors, fatigue is named as being one of the most debilitating factors that decreases quality of life. This condition is characterized by overwhelming tiredness that cannot be remedied by a good night’s sleep. People with fatigue report that they are unable to participate in normal daily activities. Fatigue can often be the first sign of something wrong that sends patients to their doctor, leading to a brain tumor diagnosis. Fatigue may also impact people during brain tumor treatments such as surgery, radiation and chemotherapy. Brain injury in general can cause fatigue, as well as emotional stress. It can continue for several months to years. Caregivers can also experience fatigue.

This condition can creep up on you and before you know it, knock you down. It’s therefore important to take action early because combatting fatigue is essential for good health and wellbeing. Quality of life scientists are conducting research to better understand fatigue and ways to manage this debilitating condition. Meanwhile, here are some current tips on how to manage fatigue.

  • Don’t wait for fatigue to become overwhelming. Talk to your doctor or nurse if this symptom is becoming a challenge for you.
  • Talk to your doctor about your medications. Sometimes medications, chemotherapy or drug interactions can cause fatigue so you may want to ask your doctor about this.
  • A regular exercise regimen may control some of the fatigue. Yoga and other forms of exercise have been shown to decrease fatigue.
  • Eat a balanced diet, rich in protein, fruits and vegetables. High intake of processed sugar can rapidly raise and lower blood glucose levels which contributes to tiredness.
  • Prioritize your time to the most important activities. Your energy is like money in a bank account. There is only so much energy to spend in a day, so you have to be very selective about how you use it. Survivors and caregivers must decide what are the most important activities and events for them. All other activities will just have to wait.
  • Ask for help. Friends and family want to help, but they need to have some direction. Develop a weekly routine where other people can take over some tasks. Divide and conquer!

About the Author: Mary Lovely Ph.D. RN, CNRNs

Consider Becoming a Medical Explorer in the Fight Against Brain Cancer

Patient recruitmentBrain cancer is a devastating disease. Patients and their family and friends are shocked when they are diagnosed with brain cancer. Many people can describe the event or series of events that were the tell-tale signs leading up to their diagnosis and are often overwhelmed with the volume of information and adapting to their “new normal”.

Standard treatment for newly diagnosed glioblastoma or anaplastic astrocytoma includes safe surgical removal of as much of the tumor as possible followed by radiation therapy and chemotherapy. Unfortunately, despite these treatments, the tumor usually recurs. Patients and families may find it empowering to plan ahead with their care team to determine which options may be suitable for them in the event of a recurrence, including consideration of a clinical trial and becoming a medical explorer.

About the Author: Mary Lovely Ph.D. RN, CNRNs

Top Three Tips for Brain Cancer Patients and Their Caregivers

top-tipsOver the last 30 years I have supported hundreds of patients and their caregivers in their fight against brain cancer. From this experience, three of the most important things patients and their caregivers can do is:

  • Seek care at the most experienced institution near you that sees brain cancer patients every week. These are usually the larger medical centers and ideally will have a dedicated brain tumor center with a neurosurgeon that routinely operates on brain tumors and a neuro oncologist, a specialist in brain tumor treatment, who provides follow-up care.
  • Get help – you are not alone in this fight. Having the diagnosis of a brain tumor can be very isolating. Involve family, friends, and get involved with your local support group. A great list of support groups is available on ABTA’s website here: http://www.abta.org/brain-tumor-treatment/brain-tumor-support/support-groups/. Support groups can be found in the community where people meet together or they can be on line. Also, ask your doctor, nurse or social worker about brain tumor support options in your area.
  • Consider clinical trials. Participation in a clinical trial may not be for everyone but if patients are interested, they can do research and talk with their doctor about clinical trial options. A great resource is here at: virtualtrials.com.

About the Author: Mary Lovely Ph.D. RN, CNRNs