37-Year-Old Woman’s Painful Headaches Turned Out To Be Glioblastoma— But After a Life-Saving Clinical Trial, She’s Living Life To The ‘Fullest’

After having the tumor removed, Valle agreed to participate in a clinical trial designed to open the blood–brain barrier—a protective layer of cells that blocks most medications from reaching the brain, shielding it from harmful side effects but also making brain diseases more difficult to treat.

Valle recounted to CBS News about her thoughts on joining a clinical trial, among 34 participants, “It was a no-brainer. This could save my life.”

The clinical trial Valle took part in was led by University of Maryland School of Medicine (UMSOM) researchers. The trial showed that temporarily opening the blood–brain barrier with focused ultrasound during standard chemotherapy improved overall survival by nearly 40 percent.

RELATED: Top Experts Say The FDA’s New Guidelines For Clinical Trials Have Huge Implications For Patients, The Crucial Research That Saves Lives

Study principal investigator Graeme Woodworth, MD, Professor and Chair of Neurosurgery at UMSOM and Neurosurgeon-In-Chief at the University of Maryland Medical Center (UMMC), said in a statement, “Our results are very encouraging.

“Using focused ultrasound to open the blood-brain barrier and deliver chemotherapy could significantly increase patient survival, which other ongoing studies are seeking to confirm and expand.”

Thankfully, Valle, who recalls experiencing zero side effects from the trial, said she was dubbed to have no evidence of disease four years after her diagnosis.

WATCH: What to Know Before Enrolling in a Clinical Trial

The trial’s results were ultimately published in the journal Lancet Oncology, revealing that participants experienced a median progression-free survival of nearly 14 months, compared with eight months for those in the control group. Additionally, overall survival was notably longer, with participants living an average of more than 30 months versus 19 months for the control group.

Following Valle’s experience with trial, she described herself as “truly an outlier” to CBS News.

“I don’t think about the cancer. It doesn’t serve me to live life worrying about if it returns,” said Valle, who is focused on planning a European getaway to ski.

“I’ve always been a ‘Live life to the fullest’ person. Why change that now?”

Valle now undergoes annual MRIs to ensure there is still no evidence of cancer, but she says she refuses to dwell on the “what ifs,” choosing instead to focus on living her life.

It’s important to understand that Glioblastoma (GBM) is the most aggressive and lethal form of primary brain tumor. Classified as a Grade 4 glioma by the World Health Organization (WHO), glioblastoma presents significant challenges for treatment due to its highly invasive nature, rapid growth, and resistance to most conventional therapies.

As per the National Cancer Institute, the average survival rate is 15 months with treatment and less than six if left untreated. While there is a five-year survival rate of averaging 6 percent, those individuals will never be cancer-free. They must continue receiving radiation and chemotherapy for the rest of their lives.

Clinical trials help doctors better understand cancer and discover more effective treatment methods. They also allow patients to try a treatment before it’s approved by the U.S. Food and Drug Administration (FDA), which can potentially be life-changing.

WATCH: Clinical Trials can be Life-Saving

Turning to SurvivorNet for Help

For patients and families navigating a brain cancer diagnosis, or any cancer diagnosis, finding trials like Valle did can feel overwhelming. That’s why SurvivorNet encourages patients to use its proprietary Clinical Trial Finder, a free tool designed to help patients identify relevant trials quickly and easily.

Every year, new early-phase studies come online, each one representing another step forward.

As Dr. Simon Khagi, a neuro-oncologist at the Hoag Family Cancer Institute in Newport Beach, California, previously explained to SurvivorNet, progress in glioblastoma won’t come from a single breakthrough, but from smart combinations, persistence, and continued participation in clinical trials that keep hope alive where it once didn’t exist.

Understanding Glioblastoma Multiforme (GBM) & The Standard Of Care

Glioblastoma multiforme (GBM) is the most aggressive form of brain cancer. It grows rapidly and infiltrates surrounding brain tissue, making it challenging to treat. A diagnosis of glioblastoma is indeed overwhelming, but understanding your treatment options can empower you to make informed decisions about your care.

After you’ve had a full work-up, experts say getting a consultation at a treatment center that sees a lot of patients with brain cancer can be an extremely valuable step.

A Utah Brain Cancer Expert’s Quick Guide To The ‘Standard of Care’ Treatment Options For Glioblastoma

Dr. Randy Jensen, a neurosurgeon at Huntsman Cancer Institute in Salt Lake City, tells SurvivorNet that the standard of care for glioblastoma is typically to start with surgery.

“The standard of care for glioblastoma is to start off with a maximal safe resection, and that means having your surgeon pull out all the stops of anything they can do to maximize resection [removal],” Dr. Jensen explains.

While surgery is often where treatment starts, the treatment path for glioblastoma requires a comprehensive approach involving multiple medical specialties. Your care team may include neurosurgeons, medical oncologists, radiation oncologists, neuro-oncologists, and supportive care specialists.

The treatment approach for glioblastoma may consist of the following steps.

1. Surgery: The first step in treatment is often surgical removal of the tumor, also known as resection. The goal of surgery is to remove as much of the tumor as possible while preserving neurological function. Complete removal is often difficult due to the tumor’s infiltrative nature, but reducing the tumor size can improve the effectiveness of subsequent treatments. In cases where surgery is not possible due to the tumor’s location, a biopsy may be performed to confirm the diagnosis.
2. Radiation Therapy: Following surgery, most patients undergo radiation therapy to target any remaining cancer cells. Radiation uses high-energy X-rays or protons to damage the DNA of tumor cells, preventing them from growing and dividing. It is typically administered five days a week over a period of six weeks. Radiation therapy is a crucial component in slowing tumor progression and improving survival rates.
3. Chemotherapy: Temozolomide (TMZ) is the standard chemotherapy drug used in glioblastoma treatment. It is taken orally and works by interfering with the tumor cells’ ability to replicate. TMZ is often used in combination with radiation therapy (concurrent chemoradiation) and then continued as maintenance therapy for several months.
4. Tumor Treating Fields (TTFs): TTFs are a newer, non-invasive treatment option that uses alternating electrical fields to disrupt cancer cell division.

Dr. Jensen explains that after surgery for brain cancer, a tumor board meeting often occurs, where doctors with different specialties meet to assess the case together and decide the best way to proceed with treatment.

The purpose of the tumor board is to give brain cancer experts with different specialties the opportunity to discuss and decide on the best possible treatment approach.

Side Effects of Glioblastoma Treatment

Each glioblastoma treatment comes with potential side effects. Your medical team will work with you to manage these effects and improve your quality of life.

Surgery side effects can include:

• Swelling in the brain (edema), which may require steroids to reduce inflammation
• Neurological deficits, such as difficulty speaking, memory problems, or muscle weakness, depending on the tumor’s location
• Infection or bleeding at the surgical site

Radiation side effects can include:

• Fatigue, which can persist for weeks after treatment ends
• Hair loss in the treated area
• Skin irritation or redness
• Cognitive effects, such as difficulty concentrating or memory problems

Chemotherapy side effects can include:

• Nausea and vomiting
• Increased risk of infections due to lower white blood cell counts
• Fatigue
• Low blood platelet levels, which can increase the risk of bleeding or bruising

Tumor Treating Fields (TTFs) side effects can include:

• Skin irritation from the transducer arrays
• Mild to moderate headaches
• Scalp sensitivity
• Psychological adjustment to wearing the device for extended periods

When Are Tumor Treating Fields Used?

Tumor Treating Fields (TTFs) represent an exciting advancement in glioblastoma treatment. This therapy is designed to slow tumor growth without affecting healthy brain tissue.

TTFs use low-intensity, alternating electric fields to disrupt cancer cell division. This is achieved through a wearable device that delivers continuous therapy on the scalp. These fields interfere with the tumor cells’ ability to multiply, ultimately slowing or stopping tumor progression.

Two major clinical trials, EF-11 and EF-14, demonstrated that TTFs provide a survival benefit for glioblastoma patients:

• EF-11 Trial: This trial focused on recurrent glioblastoma and found that patients receiving TTF therapy had comparable survival rates to those receiving chemotherapy, but with fewer side effects
• EF-14 Trial: This trial demonstrated that newly diagnosed glioblastoma patients who used TTFs alongside standard chemotherapy had significantly improved survival compared to those who received chemotherapy alone

TTFs may be recommended in the following scenarios:

• Newly Diagnosed Glioblastoma: After surgery, radiation, and chemotherapy, TTFs can be integrated into the treatment plan to enhance survival rates. The device is typically used continuously for at least 18 hours per day to maximize its effectiveness.
• Recurrent Glioblastoma: For patients whose tumors have returned, TTFs may be an option to extend survival and manage disease progression.

Your healthcare team will assess your overall health, tumor characteristics, and previous treatments to determine if TTFs are suitable for you. Factors such as your ability to wear the device consistently and your comfort with its use will also be considered.

What to Consider When Clinical Trials Are an Option?

Within the U.S., all new drugs must go through clinical trials before the FDA approves them. Although the rewards of clinical trials can be great, they also come with risks. Talking to your doctor about this before enrolling in a trial is important. Some risks to consider include:

• The risk of harm and/or side effects due to experimental treatments
• Researchers may be unaware of some potential side effects of experimental treatments
• The treatment may not work for you, even if it has worked for others

Before you enroll in a trial, you must be allowed to read the consent documents thoroughly and to ask any questions you may have. The documents will likely contain the following:

• The purpose of the research
• Any risks and benefits expected from the research
• Information about procedures that may cause discomfort (like frequent blood tests)
• Any alternative procedures the patient might consider instead
• How the patient’s information will be kept private
• How long is the study expected to take
• A form confirming you are participating in research voluntarily
• Whether any compensation or additional medical care is available if some sort of injury occurs
• The patient’s rights (like the right to stop research in the middle of the trial)
• Contacts for any patient questions

Patients are allowed to walk away at any time during the trial. Understanding your rights as a voluntary patient is important before you participate in a clinical trial, and understanding that the treatment may not work is also crucial.

Do Clinical Trials Cost Participants Anything?

Clinical trials may also have no extra cost for the participants, as the study’s sponsor may pay for the treatment and any additional care. Some sponsors even pay for travel to and from appointments or treatment centers. Patients should ask what will be paid for before signing up to be part of a trial.

The ‘Placebo’

During the treatment of an experimental drug in a clinical trial, while some participants receive the real thing, others do not. These participants receive a placebo.

The placebo is “an inactive substance or other intervention that looks the same as and is given the same way as an active drug or treatment being tested. The effects of the active drug or other intervention are compared to the effects of the placebo, as defined by the National Cancer Institute.

In some cancer clinical trials that are “randomized,” patients who enroll are randomly assigned to receive either a placebo or the new experimental drug being studied. If the clinical trial is “double-blinded,” that means that neither the patients nor the doctors running the clinical trial know who’s in which group. This is an important part of a clinical trial design because it safeguards against bias and the possibility of skewed results.

It’s important to know that getting zero treatment isn’t usually the reality of the “placebo arm” anyway.

Instead, when patients with life-threatening cancers enroll in randomized clinical trials, the two groups are often broken into the new, experimental drug and a “control” group that receives the “standard-of-care” treatment.

Treatments considered standard of care are those that experts accept as the go-to treatment for specific cancers. Standard-of-care, in other words, is the most used treatment.

In many cases, it might involve a combination of chemotherapy, surgery, or radiation, but not always.

Questions for Your Doctor

If you have been diagnosed with glioblastoma, here are some questions you may consider asking your doctor:

• What stage is my brain cancer?
• What are the treatment options for my brain cancer?
• What are the risks and benefits of the recommended treatment?
• What are the side effects of the recommended treatment?
• How long will it take to recover from treatment, and will I be able to return to work and normal activities?
• What’s the likelihood that insurance will cover the recommended treatment

WATCH: Using electric sources to improve glioblastoma treatment.

Contributing: SurvivorNet Staff

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