Frequently Asked Questions
What is a brain tumor? How does it affect the body?
A brain tumor is a mass of abnormal cells in the brain. If you think about it in its most basic form, the brain is an elaborate, elegant and sophisticated mass of tissue and nerve cells. It seamlessly controls our personality, our senses, helps regulate vital body functions and controls how we move in our environment. When abnormal cells grow in the brain to develop a tumor, it can disrupt how we function and requires treatment considerations that balance how the tumor is treated with how well the brain operates.
Why should patients seek out the Ivy Brain Tumor Center as opposed to other treatment locations?
For brain tumor patients facing the fight of their lives, no stone should be left unturned. Our team treats more brain tumor patients than any hospital in the nation and our portfolio of early-phase clinical trials serves as resource for the world’s brain tumor community — we are ready to take on every individualized challenge with a new approach. Seeking medical treatment can also place a huge burden on patients and their families. At the Ivy Brain Tumor Center, Trial Screening Requests are provided at no cost and, for patients we determine to be eligible for clinical trials, we cover all costs associated with study participation outside of the standard of care.
What is a ‘clinical trial’?
Clinical trials are studies designed to test the most promising new treatments available for patients. People choose to participate in clinical trials for a variety of reasons:
- To try a new and promising treatment method
- To contribute to the development of future treatments
- To help find a cure for a specific disease or illness
Clinical trials test new drugs, equipment, and treatments that the US Food and Drug Administration (FDA) has not yet approved, and new surgical techniques. Clinical trials also may test a new drug with standard treatment that is already FDA approved.
What constitutes a ‘Phase 0’ clinical trial?
Phase 0 clinical trials are exploratory studies that accelerate and streamline the drug testing and approval process, allowing new drug combinations to be evaluated in patients in as little as seven days. Through this approach, a patient is given a single dose of the experimental drug before a planned tumor surgery. During surgery, our team collects and tests tumor tissue to determine if the drug is having an effect. Ultimately, Phase 0 clinical trials mean that patients, regardless of diagnosis, can have individualized treatment in a fraction of the time and costs associated with traditional drug research and development.
What are Phase 0/2 clinical trials?
Clinical trials are a very important part of clinical research. Phase 0/2 clinical trials, in particular, combine the early development of new drugs with treatments for cancer and other diseases. They bridge the gap between initial drug testing and patient studies, with the goal of providing a better understanding of how a drug works in a shorter amount of time and for less cost. Phase 0/2 clinical trials match brain tumor patients to first-in-class drug combinations, confirm drug effects within days of exposure, and only treat patients when therapies are active in their own tumor.
What are the benefits when a patient chooses to participate in a Phase 0 trial?
There are many benefits associated with this choice, the most important ones being:
- The patient receives personalized treatment for their unique tumor.
- And most importantly, they will have results within a few weeks of surgery.
If the Phase 0 study does not have the desired effect, they won’t lose time seeking out other treatment.
What costs are involved in study participation?
As part of a clinical trial at the Ivy Brain Tumor Center, the study drugs will be provided free of charge, however, the patient and/or their health plan/insurance company will be responsible for some or all of the costs of treating the tumor in the study, including any standard medical care such as surgical resection. We encourage all patients to ask their study doctor to discuss the costs that will or will not be covered by the study, including who will pay the costs of treating possible side effects.
What is the surgical process like for patients with brain tumors?
Surgery is used to diagnose and treat brain tumors. Ideally, the brain surgeon (neurosurgeon) can completely remove a brain tumor with surgery. If complete removal is not possible, the surgeon will remove as much as possible (called a resection or debulking) without negatively affecting the brain’s neurologic functions. If a resection is not possible, then a biopsy will be done (removing a small piece of tumor tissue) to diagnose the tumor type and grade so treatment recommendations can be made.
What is ‘Targeted Drug Therapy’? How does it relate to Phase 0 Clinical Trials?
Targeted drug treatments focus on certain defects within tumor cells. By blocking these defects, targeted drug treatments can cause tumor cells to die. Many targeted therapies are still being studied and implemented in clinical trials, such as the Ivy Brain Tumor Center’s Phase 0/2 clinical trials.
How does the Ivy Brain Tumor Center coordinate with physicians and primary care doctors?
The Ivy Brain Tumor Center is here to serve as a resource to the world’s brain tumor community. Patients enrolled in our studies are not required to transfer their care to our Center, as our philosophy is to partner with, not replace, their treatment team. While assessing a patient’s suitability for our clinical trials program, our dedicated team also provides support to the physicians managing these cases and works in partnership to create a patient-centered path forward.
Why aren’t there more brain tumor treatment options widely available to patients?
Drug discovery is much harder than it used to be. The result is that researchers and doctors are being intensely motivated to think outside-the-box in order to help our patients.
A drug’s development can require up to 20 years from the time it is first discovered, until it can be thoroughly tested and then marketed. Costs of developing a new drug can hit $800 million and reach as high as $1.8 billion.
Even with all that investment, today a new drug has only a 5 percent chance of making it to commercial use, down from the historical success rate of 14 percent in 1985.
Who makes up the Ivy Brain Tumor Center team?
Through the Barrow Neurological Center, our multidisciplinary team of scientists, regulatory personnel, neurosurgical oncologists, clinical neuro-oncologists, radiation oncologists, radiation oncologists, nurse specialists, clinical therapists, and social workers is dedicated to providing patients with state-of-the-art clinical care so that they can get back to their daily life as soon as possible.
What determines the treatment required for different types of brain tumors?
Treatment for a brain tumor depends on the type, size, and location of the tumor. Your age and overall health will also be considered in developing your personal treatment plan. Because a treatment plan is heavily determined by the specific tumor type, surgery is commonly recommended as the first line of treatment so that a tumor type (diagnosis) can be confirmed.
How does research play a part in the Ivy Brain Tumor Center’s operations?
Doctors, scientists, nurses and coordinators at the Ivy Brain Tumor Center carry out research studies in our labs and also in the Phase 0 clinical trials involving patients. Research studies help us to better understand how brain tumors grow and behave with certain treatments. Clinical trials help us to discover better ways to diagnose and treat patients with brain tumors. Ultimately, through a combination of approaches, our goal is to find a cure for brain tumors.
The Ivy Brain Tumor Center is a non-profit entity. What role does philanthropy play?
Financial support from individuals and families allows the Ivy Brain Tumor Center to fund programs and services that advance research, improve treatments and ultimately work to find a cure for brain tumors. Additionally, donations provide patient education and enhanced patient care.
Some regular donors are former patients of Barrow Neurological Institute, some have had a friend or family member who received exceptional care from us in the past, and some are simply people that want the very best for their community and peers. While unique in their own ways, every donor shares a common and commendable trait of generosity that allows us to stay at the cutting edge of neuroscience.
What is the typical survival rate for your patients and how does it compare to current standards of care at other cancer institutions?
Survival rates depend upon specific characteristics of the tumor and the patient including age, tumor grade, tumor subtype, tumor genetics, comorbidities, and prior therapies. They are therefore widely variable at every major brain tumor center because each patient is different. Comparing survival rates among institutions is relatively unreliable today because there is so much heterogeneity in patients and each brain tumor. That being said, we generally advise patients to seek multiple opinions when assessing their cancer care options and to seek care at an institution where they feel most comfortable with the individuals who will be working with them directly. At the end of the day, your treatment team is your extended family.
Is a patient excluded from Ivy clinical trials if they have participated in a clinical trial elsewhere and experienced progression? Are they excluded if they have been on Avastin or Gliadel?
Prior clinical trial participation is not an exclusion criteria, nor is prior exposure to Avastin or Gliadel.
What is the reasoning behind a Phase 0 Clinical Trial?
Phase 0 trials allow us to determine if possible medications have the ability to cross the blood-brain barrier and hit their intended tumor targets. Phase 0 trial results can quickly eliminate drugs that don’t measure up to their promise or hype, saving patients time and valuable resources. These trials also accelerate drug development by identifying promising agents that are truly delivering. These drugs and drug combinations are then moved quickly through the regulatory process towards FDA approval.
Who is eligible for a Phase 0 clinical trail?
As each study is unique in enrollment criteria, we encourage you to submit your information through our secure Trial Screening portal. Someone from our team will reach out to you within two business days to follow up with you on enrollment requirements.
What is known about the type of treatment being studied?
Each drug administered in an Ivy Brain Tumor Center study has gone through prior rigorous testing by our lab for effectiveness in brain tumors. If you have questions regarding a specific study, we encourage you to contact us directly.
What are the risks/benefits based on what is known so far utilizing these study drugs?
Some of the risks of the study are related to side effects which may be mild or very serious. Side effects can be serious, long-lasting, or may never go away. Everyone taking part in the study will be watched closely for any side effects. Refer to the consent document for more details of possible risks when enrolling in the study. A benefit of enrolling in the study is that the information gained will help in the treatment of future patients with conditions like yours. If your results from the Phase 0 study show that a treatment phase of these drugs would be helpful to you we will offer the option to advance to a Phase 2 study.
What is the timeline (from start to finish, of tests involved, how often will I meet with a Physician/RN, etc.)?
Generally speaking, the genetic testing for each study takes about two weeks. Patient eligibility will then have to be confirmed with baseline labs. After eligibility confirmation, your dosing schedule will be arranged by our research team. The number of required visits will be dependent on the study type. Our team will make sure you are aware of what is to be expected and when.
What is informed consent?
The process of providing key information about a research study in order to decide whether to accept the option of entering or not. This process continues throughout the entire study. The consent document will include details of the study, its purpose, duration, tests or procedures performed as part of the research and contact information for further information. Risks and potential benefits are included in the document. Taking part in the clinical trial is voluntary and you can leave the study at any time.
How is the safety of each participant protected?
Clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) which ensures that any risks are minimal when compared to potential benefits. This is an independent committee responsible for ensuring ethics and rights of participants are protected.
Can a patient leave a clinical trial after it has begun?
Absolutely. Clinical trials are voluntary. A patient can withdraw from a clinical trial at any time by notifying the study staff. If a patient decides to leave a study they will not be penalized or lose any benefits in their clinical care.
Why should I participate?
Your involvement helps researchers uncover better ways to treat, prevent, diagnose, and understand brain tumors. You may or may not directly benefit from participating in the study; however, the information gained from this study will help other people in the future.