Dellann Elliott Mydland

patients, caregivers, family members and advocacy organizations can help shape the clinical practice recommendations that guide doctors in treating brain cancer, as well as treatment guidelines aimed at patients?

The EndBrainCancer Initiative (EBCI) has an ongoing opportunity to provide input about clinical practice guidelines as well as patient guidelines released by the National Comprehensive Cancer Network (NCCN), and we want to incorporate insights from the brain cancer community in the next update. We are also asking patients with metastatic disease to the brain to tell us what would make their journey better.

The NCCN issues guidelines for physicians that set forth standard treatment protocols for specific cancer types and stages. The aim is to provide standards of care for clinical practice and ensure that all patients have equal access to the most appropriate diagnostic testing and treatments, no matter where they receive care, to ensure the best possible outcome.

It’s important that patients are familiar with these protocols, as well, so they’re able to ask for appropriate diagnostic testing and treatment if they aren’t receiving it. That’s why the NCCN also issues patient versions of its guidelines.

NCCN’s patient guidelines are reviewed and updated periodically to reflect advances in diagnostic testing and treatment of brain cancer and other solid tumors, so it’s imperative that the patient voice be an integral part of these updates, last done in 2016. That’s why we’re asking those in the brain cancer community to tell us what’s meaningful to them when it comes to treatment options and quality of life. We ask that patients email us their suggestions, stories and pictures to 

In addition to using these insights to educate the public and pharmaceutical companies

about what’s meaningful to those with brain cancer, we’ll share the feedback with the NCCN for possible inclusion in its patient guidelines on treatments for central nervous system (CNS) cancers — including gliomas and other brain cancers.

We’ll also share some of these patient experiences and suggestions in a white paper we plan to submit to the advisory panel responsible for updating NCCN’s clinical treatment guideline for CNS cancers.

The main thrust of our paper will be to communicate our desired guideline updates, along with supporting data. EBCI is seeking grant funding and donations to support this work. Please contact Dellann@EndBrainCancer.org if you or your company can help fund this effort.

We want the guidelines to state that patients with brain cancer should, upon diagnosis, have all their treatment options presented to them: clinical trials, surgery, radiation, chemotherapy

and Optune (a wearable device that delivers low- intensity electronic fields, known as tumor treating fields, that help to stop the growth and division of glioblastoma cells).

Furthermore, patients should be advised to take time before surgery to arrange to save their tumor tissue and have genomic testing done on it, with assurance that the tissue will remain available if the patient ever needs it to create a personalized vaccine or for testing to allow enrollment in a clinical trial.

Not every hospital saves patients’ tumor tissue or has genomic testing done on it if patients don’t ask. And even when they do, hospitals often check for just a few genetic mutations/ biomarkers that can help doctors accurately diagnose and categorize a brain tumor and brain cancer.

Patients should know that it’s much better if tumor tissue undergoes next-generation sequencing, which tests for about 500 mutations that could be linked to brain cancer. Scientists are testing drugs that target a variety of mutations, but to enter these clinical trials or get the drugs that target these specific mutations/biomarkers through the FDA’s compassionate use program, patients need to know their tumor’s mutational status.

The most recent NCCN CNS clinical treatment guidelines were published in November 2019, and we’re happy that some of the updates we’ve been advocating for were included.

The guideline encourages genetic testing of brain tumor tissue but does not demand it; however, it does tell physicians to test the tissue for expression of the proteins IDH1 or IDH2, and for methylation of the enzyme MGMT, meaning it has undergone chemical changes. The MGMT information is critical in informing the treatment decision since these characteristics mean the tumor is more likely to respond well to alkylating chemotherapy, such as Temodar (temozolomide).

In March 2020, the NCCN updated the documents with preferred practices that will probably be finalized as recommendations in the November 2020 publication. In that document, we are hopeful that the NCCN will state that the standard of care for gliomas must include the saving of tumor tissue, patient access to it, next-generation sequencing and the use of that data to stratify patients into appropriate clinical trials, whether at the patient’s treating facility or somewhere else. In our white paper, we’ll argue that this is not only important from a patient perspective, but also in the research world. Think about how much research data is being lost in this patient population, and how that’s stifling research and clinical trial enrollment!

To further be a part of the NCCN’s process, EBCI has entered into a permissions agreement to distribute the patient version of the CNS guideline. We’ll offer it online and will seek grants and donations to distribute this information in hard copy as we feel it’s incredibly important to get this into everyone’s hands.

Finally, we will soon be listed in the NCCN patient guidelines for CNS tumors as an endorser, which will help patients with brain cancer find us and seek our help. EBCI can then connect these patients to a brain tumor center that routinely performs next-generation sequencing and offers a wide variety of treatment options.

Our mission every day is to introduce patients and their caregivers to brain tumor specialists and/or clinical trials and advanced care. Through our national Direct Connect program, we provide education and help patients to manage distress, create action plans, find second opinions, work with health insurers, search for clinical trials, seek compassionate use of drugs and fill the role of patient navigator to guide them through the process.

To use Direct Connect, contact clinical research nurse and patient navigator Delores Kannas, M.S.N., M.H.A., RN, by filling out EBCI’s patient/caregiver inquiry form at endbraincancer.org/inquiry-form/, emailing Delores@ EndBrainCancer.org or calling her directly at 424-444-2215 Monday through Thursday, 10 a.m. through 4 p.m. PT. 

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The EndBrainCancer Initiative wants patient concerns reflected in national treatment guidelines.
 

Having a Say in Shaping Brain Cancer Treatment

“I’M SORRY, BUT THERE isn’t anything else I can do for you.”

Many patients fear hearing that statement from their doctors if standard treatments for cancer stop working.

But even when those words are spoken, they don’t always mark the end of a patient’s treatment journey. An option for some may be expanded access programs, which offer promising experimental drugs — outside the structure of clinical trials &mdash; to seriously ill people who have exhausted other treatment options. In some cases, drug developers run these “compassionate use” programs, which do not focus on collecting safety or efficacy data, for groups of patients; in others, they are designed to accommodate just one person. Often, developers foot the bill for the treatments.

These programs are rare, but the process of joining them got a bit less complicated in early October, when the Food and Drug Administration (FDA) streamlined the steps doctors must take to enroll patients who meet eligibility requirements by creating a shorter application form, FDA 3926.

An advantage of expanded access programs is that every eligible patient who is enrolled gets the experimental drug in question. This does not always happen with clinical trials, since some participants may be placed in a control group receiving standard-of-care treatment.

Of course, we at the EndBrainCancer Initiative (EndBrainCancer.org) strongly advocate participation in clinical trials. Through our Direct Connect and Clinical Trial Prequalification programs, we often find appropriate studies for people with brain cancer, and help them enroll. However, people with serious illnesses or rare diseases might not qualify for these trials due to specific inclusion or exclusion requirements.

Still, we believe that all patients should have immediate access to advanced treatments for which they are eligible, even if the therapies are still experimental, and sometimes expanded access programs offer more leeway. That’s why we encourage patients with cancer to tell their doctors, at the outset of treatment, that they are interested in expanded access programs and would like these options factored into their therapy plans. Patients may not know which drugs, if any, they will later be interested in trying, but they can get the process rolling by putting their doctors on alert and giving them copies of the FDA form.

Admittedly, learning about and enrolling in these programs is not simple.

A patient might find an appropriate one by searching ClinicalTrials.gov and drug company websites, or by checking with the FDA at 855-543-3784. A promising program’s sponsor can provide details about joining.

For a drug of interest that offers no expanded access program, a doctor can — after first getting the backing of his or her hospital or independent institutional review board &mdash; ask the developer to create one. Once those steps have been taken, the patient can help by contacting the drug’s maker and arranging for its representative to meet with the doctor. It’s a good idea to act quickly, because the approval process can take as long as two months.

Once the drug maker grants permission, the patient should give the doctor Form FDA 3926, or explain that it can be obtained by visiting tinyurl.com/ycw3w2mx, calling 855-543-3784 or emailing druginfo@fda.hhs.gov. Luckily, this part of the process can move much faster. In emergency cases, the FDA authorizes submissions in a matter of days, or even over the phone in just hours. Moreover, the FDA ultimately authorizes 99 percent of such requests.

When creating a cancer treatment plan, a doctor should talk to the patient about standard- of-care treatment for his or her disease; any gene mutations that drive that kind of cancer and are treatable with drugs; clinical trials; and expanded access to treatments. The doctor should also provide relevant information about drug safety and efficacy, as well as estimated costs of treatment, diagnostic tests, supportive care and any related travel. If your doctor does not discuss these topics with you, be your own advocate and ask.

IF YOU HAVE A brain cancer or tumor and have questions, or would like to be coached on how to discuss expanded access programs with your doctor, please contact our “Direct Connect” center at EndBrainCancer.org or call us at 425-444-2215. You can also reach our patient navigators online by visiting our website and filling out a patient inquiry form.

DELLANN ELLIOTT MYDLAND is founder and president of the EndBrainCancer Initiative, whose goal is to provide patients with immediate access to top brain cancer specialists, advanced treatments and clinical trials. She founded the group 14 years ago with her late husband, Christopher Stewart Elliott, who died of glioblastoma in 2002.

An easier application process could make experimental drugs more accessible to patients in need &mdash; outside the realm of clinical trials.

Expanding Expanded Access

Dellann Elliott Mydland, founder and president of the EndBrainCancer Initiative and 2016 GBM Hero, discusses how miracles do happen in the world of glioblastoma multiforme (GBM), and people survive.

It is crucial to have hope when facing this type of brain tumor, and those who survive often have a top brain surgeon, have their tissue saved and get into clinical trials or new treatment quicker. Through EndBrainCancer's Direct Connect program, the organization is hoping to make this a reality for more patients.

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Miracles Do Happen in GBM

It is with great pleasure that I accept this opportunity to write a piece for 

		Informative, insightful and inspirational

		Encourage a change for patients diagnosed with an initial glioblastoma (GBM) brain tumor in the areas of initial diagnosis, initial surgery and a change in our current standard of care. This will be done through providing immediate access to advanced treatments, studies and clinical trials.

The change I am referring to is a significant shift in current standard of care. This includes discussions related to prior consent, immunotherapy, vaccines, devices, DNA sequencing/genomic profiling, MGMT testing and so on. It also includes discussions related to advanced treatments, targeted therapies and/or clinical trials prior to surgery — essentially, a much more proactive and personalized approach for this disease at the time a primary cancerous brain tumor or metastatic brain tumor is diagnosed.

You may be wondering who am I and what the EndBrainCancer Initiative |Chris Elliott Fund is. First of all, I want to share information that I have learned through personal experience, as a brain cancer advocate and I love to write. Secondly, I have now been immersed in the brain tumor community locally and nationally for nearly 16 years. You see, I am like many of you who have a loved one who was diagnosed with this disease. My late husband, Christopher Stewart Elliott, was diagnosed with brain cancer and lost his battle with this disease. I have personally gone through some of what you are experiencing: shock, desperation, frustration and truthfully, the inability to understand why there are no effective treatments for this disease and why patients are not routinely referred to the top neurosurgeons/neuro-oncologists for this disease.

Today, and for the last 13 years, our Care Coordinator Team and I have been working through our Brain Tumor Patient Support Services & Call Center located just east of Seattle. The work we do through the EndBrainCancer Initiative | Chris Elliott Fund and our “Direct Connect” one-on-one personalized program (plus the use of technology) provides immediate access and educates patients and their caregivers, families and friends about advanced treatments and clinical trials with the belief and goal of moving, patient-by-patient, brain cancer patients into clinical trials as soon as possible. While we initially saw this as providing “patient support,” we recently realized that through our efforts and day-to-day work that, as an organization, we were essentially fueling and accelerating research.

With this realization came the concept for the EndBrainCancer Initiative, which is a focused collaborative effort between founding partners, biotech/biomed, pharma, device companies and top brain tumor neurosurgeons and neuro-oncologists. Its goal is to quickly and effectively change this disease and its outcomes by actively practicing a patient-focused, immediate-access and an advanced treatment-approach to treatment as current standard of care for this patient population is relatively unsuccessful.

It dawned on me yesterday in a conversation with the immediate past boss of my late husband, Chris, that we will never have an effective treatment for this disease if we continue to get these patients into clinical trials after their brain cancer has returned (rGBM). At this point, the disease is actually a different disease as the molecular structure of the tumor has changed. The tumor is not the same tumor that it once was. Therefore, why are we treating most of these tumors in the same way and why are so few of these patients entering into clinical trials? Why aren’t we taking a more proactive approach to advanced treatment for this disease and not the current standard of care?

The EndBrainCancer Initiative & Collaborative is dedicated to educating cancer patients and their families about advanced treatments and clinical trials and to having this discussion take place much earlier in the treatment process — perhaps even at the time of a primary brain tumor diagnosis, or at the time of a malignant brain tumor diagnosis? We intend to seriously move the dial on this disease. Research is struggling because not enough patients enter clinical trials and top brain tumor neuro-surgeons are tired of cleaning up brain tumor surgeries being performed by non-specialists who do not save brain tumor tissue for research. If, through our Initiative and our “Direct Connect” program, we can change this, we potentially could quickly change the standard of care for these patients, advance research/translational medicine and lower the cost of clinical trials by approximately 50 percent. Would this not be a good thing for not only the patient but also for research? As a patient, you may not care about the cost of the clinical trial, but here is what you do care about. What if we could accelerate the time it takes to:

		Get patients into clinical trials/advanced treatments/studies

		Lower the cost of the clinical trial for the patient by getting enough patients into the trial

		Get the data out of the clinical trial/study much more quickly so that it can be used to perhaps speed up the process of opening the next clinical trial phase or …

		When appropriate, move results quickly into translational medicine and standard of care.

This effort poses the larger question: Can we create a new turning point?

If you’d like join this effort or fund this movement and/or share your thoughts and perspective, please let us know by going to 

 and leaving us a message via our Patient/Caregiver/Doctor Portal. We will reach back out to you and hope to hear from you!

I truly believe we can and must create a new turning point. With that being said, I’d like to take this opportunity to share about another collaborative effort the EndBrainCancer Initiative |Chris Elliott Fund is involved in this fall and invite all to attend by signing up here 

. We are excited to join forces with, M. Karen Newell-Rogers, PhD; Professor, Scott & White Health/Texas A&M Health Science Center College of Medicine: Director, CCDD and Eric T. Wong, MD, Brain Tumor and Neuro-Oncology Unit, Harvard Medical School and Al Musella, The Musella Foundation and proud to co-sponsor the 2nd Annual “At a Turning Point: Novel Therapeutic Developments in Glioblastoma Multiforme (GBM) Research, to be held on November 17 — 18, 2015 and is a key meeting prior to the annual Society of Neuro-Oncology’s 20th Annual Meeting in San Antonio.

I am honored to be the opening speaker for this meeting and delighted that our Keynote will be Sidney Hayes, MD, State Medicare Medical Director, Novartis, and Centers for Medicare and Medicaid Services. Please also take a moment to review the entire Agenda for this Symposium at 

. I hope to see you there! Let’s keep the conversation going. 

Could immediate access to care be the turning point?

Dellann Elliott Mydland

Having a Say in Shaping Brain Cancer Treatment

Expanding Expanded Access

Miracles Do Happen in GBM

Effecting Change in Glioblastoma

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