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Treatments and Novel Therapies Offered at the UMBTI

People with brain tumors have several treatment options, including surgery, radiation therapy, chemotherapy, and clinical trials. Many people get a combination of treatments.

The choice of treatment depends mainly on the following:

  • The type and grade of brain tumor
  • Its location in the brain
  • Its size
  • Your age and general health

For some types of brain cancer, the doctor also needs to know whether cancer cells were found in the cerebrospinal fluid.

Your doctor can describe your treatment choices, the expected results, and the possible side effects. Because cancer therapy often damages healthy cells and tissues, side effects are common. Before treatment starts, ask your health care team about possible side effects and how treatment may change your normal activities. You and your health care team will work together to develop a treatment plan that meets your medical and personal needs.

You may want to talk with your doctor about taking part in a clinical trial, a research study of new treatment methods.

Your doctor may refer you to a specialist, or you may ask for a referral. Specialists who treat brain tumors include neurologists, neurosurgeons, neuro-oncologists, medical oncologists, radiation oncologists, and neuroradiologists.

Your health care team may also include an oncology nurse, a registered dietitian , a mental health counselor, a social worker, a physical therapist, an occupational therapist, a speech therapist, and a physical medicine specialist. Also, children may need tutors to help with schoolwork.

You may want to ask your doctor these questions before you begin treatment:

  • What type of brain tumor do I have?
  • Is it benign or malignant?
  • What is the grade of the tumor?
  • What are my treatment choices? Which do you recommend for me? Why?
  • What are the expected benefits of each kind of treatment?
  • What can I do to prepare for treatment?
  • Will I need to stay in the hospital? If so, for how long?
  • What are the risks and possible side effects of each treatment? How can side effects be managed?
  • What is the treatment likely to cost? Will my insurance cover it?
  • How will treatment affect my normal activities? What is the chance that I will have to learn how to walk, speak, read, or write after treatment?
  • Would a research study (clinical trial) be appropriate for me?
  • Can you recommend other doctors who could give me a second opinion about my treatment options?
  • How often should I have checkups?

Surgery

Surgery is the usual first treatment for most brain tumors. Before surgery begins, you may be given general anesthesia, and your scalp is shaved. You probably won’t need your entire head shaved.

Surgery to open the skull is called a craniotomy. The surgeon makes an incision in your scalp and uses a special type of saw to remove a piece of bone from the skull.

You may be awake when the surgeon removes part or all of the brain tumor. The surgeon removes as much tumor as possible. You may be asked to move a leg, count, say the alphabet, or tell a story. Your ability to follow these commands helps the surgeon protect important parts of the brain.

After the tumor is removed, the surgeon covers the opening in the skull with the piece of bone or with a piece of metal or fabric. The surgeon then closes the incision in the scalp.

Sometimes surgery isn’t possible. If the tumor is in the brain stem or certain other areas, the surgeon may not be able to remove the tumor without harming normal brain tissue. People who can’t have surgery may receive radiation therapy or other treatment.

You may have a headache or be uncomfortable for the first few days after surgery. However, medicine can usually control pain. Before surgery, you should discuss the plan for pain relief with your health care team. After surgery, your team can adjust the plan if you need more relief.

You may also feel tired or weak. The time it takes to heal after surgery is different for everyone. You will probably spend a few days in the hospital.

Other, less common problems may occur after surgery for a brain tumor. The brain may swell or fluid may build up within the skull. The health care team will monitor you for signs of swelling or fluid buildup. You may receive steroids to help relieve swelling. A second surgery may be needed to drain the fluid. The surgeon may place a long, thin tube (shunt) in a ventricle of the brain. (For some people, the shunt is placed before performing surgery on the brain tumor.) The tube is threaded under the skin to another part of the body, usually the abdomen. Excess fluid is carried from the brain and drained into the abdomen. Sometimes the fluid is drained into the heart instead.

Infection is another problem that may develop after surgery. If this happens, the health care team will give you an antibiotic.

Brain surgery may harm normal tissue. Brain damage can be a serious problem. It can cause problems with thinking, seeing, or speaking. It can also cause personality changes or seizures. Most of these problems lessen or disappear with time. But sometimes damage to the brain is permanent. You may need physical therapy, speech therapy, or occupational therapy.

You may want to ask your doctor these questions about surgery:

  • Do you suggest surgery for me?
  • How will I feel after the operation?
  • What will you do for me if I have pain?
  • How long will I be in the hospital?
  • Will I have any long-term effects? Will my hair grow back? Are there any side effects from using metal or fabric to replace the bone in the skull?
  • When can I get back to my normal activities?
  • What is my chance of a full recovery?

Radiation Therapy

Radiation therapy kills brain tumor cells with high-energy X, gamma rays, or protons.

Radiation therapy usually follows surgery. The radiation kills tumor cells that may remain in the area. Sometimes, people who can’t have surgery have radiation therapy instead.

Doctors use external and internal types of radiation therapy to treat brain tumors:

External radiation therapy: You’ll go to a hospital or clinic for treatment. A large machine outside the body aims beams of radiation at the head. Because cancer cells may invade normal tissue around a tumor, the radiation may be aimed at the tumor and nearby brain tissue, or at the entire brain. Some people need radiation aimed at the spinal cord also. The treatment schedule depends on your age, and the type and size of the tumor. Fractionated external beam therapy is the most common method of radiation therapy used for people with brain tumors. Giving the total dose of radiation over several weeks helps to protect healthy tissue in the area of the tumor. Treatments are usually 5 days a week for several weeks. A typical visit lasts less than an hour, and each treatment takes only a few minutes. Some treatment centers are studying other ways of delivering external beam radiation therapy:

Intensity-modulated radiation therapy or 3-dimensional conformal radiation therapy: These types of treatment use computers to more closely target the brain tumor to lessen the damage to healthy tissue.

Proton beam radiation therapy: The source of radiation is protons rather than x-rays. The doctor aims the proton beam at the tumor. The dose of radiation to normal tissue from a proton beam is less than the dose from an x-ray beam.

Stereotactic radiation therapy: Narrow beams of x-rays or gamma rays are directed at the tumor from different angles. For this procedure, you wear a rigid head frame. The therapy may be given during a single visit (stereotactic radiosurgery) or over several visits.

Internal radiation therapy (implant radiation therapy or brachytherapy): Internal radiation isn’t commonly used for treating brain tumors and is under study. The radiation comes from radioactive material usually contained in very small implants called seeds. The seeds are placed inside the brain and give off radiation for months. They don’t need to be removed once the radiation is gone.

Some people have no or few side effects after treatment. Rarely, people may have nausea for several hours after external radiation therapy. The health care team can suggest ways to help you cope with this problem. Radiation therapy also may cause you to become very tired with each radiation treatment. Resting is important, but doctors usually advise people to try to stay as active as they can.

Also, external radiation therapy commonly causes hair loss from the part of the head that was treated. Hair usually grows back within a few months. Radiation therapy also may make the skin on the scalp and ears red, dry, and tender. The health care team can suggest ways to relieve these problems.

Sometimes radiation therapy causes brain tissue to swell. You may get a headache or feel pressure. The health care team watches for signs of this problem. They can provide medicine to reduce the discomfort. Radiation sometimes kills healthy brain tissue. Although rare, this side effect can cause headaches, seizures, or even death.

Radiation may harm the pituitary gland and other areas of the brain. For children, this damage could cause learning problems or slow down growth and development. In addition, radiation increases the risk of secondary tumors later in life.

You may want to ask your doctor these questions about radiation therapy:

  • Why do I need this treatment?
  • When will the treatments begin? When will they end?
  • How will I feel during therapy? Are there side effects?
  • What can I do to take care of myself during therapy?
  • How will we know if the radiation is working?
  • Will I be able to continue my normal activities during treatment?

Chemotherapy

Chemotherapy, the use of drugs to kill cancer cells, is sometimes used to treat brain tumors. Drugs may be given in the following ways:

By mouth or vein (intravenous): Chemotherapy may be given during and after radiation therapy. The drugs enter the bloodstream and travel throughout the body. They may be given in an outpatient part of the hospital, at the doctor’s office, or at home. Rarely, you may need to stay in the hospital. The side effects of chemotherapy depend mainly on which drugs are given and how much. Common side effects include nausea and vomiting, loss of appetite, headache, fever and chills, and weakness. If the drugs lower the levels of healthy blood cells, you’re more likely to get infections, bruise or bleed easily, and feel very weak and tired. Your health care team will check for low levels of blood cells. Some side effects may be relieved with medicine.

In wafers that are put into the brain: For some adults with high-grade glioma, the surgeon implants several wafers into the brain. Each wafer is about the size of a dime. Over several weeks, the wafers dissolve, releasing the drug into the brain. The drug kills cancer cells. It may help prevent the tumor from returning in the brain after surgery to remove the tumor. People who receive an implant (a wafer) that contains a drug are monitored by the health care team for signs of infection after surgery. An infection can be treated with an antibiotic.

You may want to ask your doctor these questions about chemotherapy:

  • Why do I need this treatment?
  • What will it do?
  • Will I have side effects? What can I do about them?
  • When will treatment start? When will it end?
  • How will treatment affect my normal activities?

Available Clinical Trials at the UMBTI

Clinical research provides the necessary information researchers use to design better treatments for brain tumors. All of our current therapies have evolved through the clinical trial process and by choosing to participate in a clinical trial, you are helping researchers find better treatments for others.

A clinical trial may also help you by:
  • Receiving an experimental drug or new brain tumor treatment not available outside a clinical trial
  • Benefitting from a team of health professionals who follow a carefully designed protocol based on the latest known evidence about cancer care
  • Knowing they are helping other people suffering from brain cancer

At the UMBTI, we offer the following trials for our brain tumor patients:

TRIALS THAT EXPLORE NOVEL TREATMENTS

Radiation Therapy guided by a novel imaging method- Phase II Study of Dose Escalated, Targeted Radiation Therapy Using 3D Magnetic Resonance Spectroscopy Imaging (MRSI) in Newly Diagnosed Glioblastoma
Physician: Fazilat Ishkanian, MD

This study is adding a newer type of imaging to deliver radiation therapy while receiving the standard treatment for Glioblastoma. During the course of your radiation therapy and chemotherapy, you will have 6 specialized scans called MRSI (3D Magnetic Resonance Spectroscopy Imaging), with or without an additional radiation dose to the active tumor site. The MRSI identifies areas of tumor activity.

Combination chemotherapy for a subtype of GBM- A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Adjuvant Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation
Physician: Macarena de la Fuente, MD

This randomized phase II/III trial studies how well temozolomide and veliparib work and compare them to temozolomide alone in treating patients with newly diagnosed glioblastoma multiforme with MGMT promoter hypermethylation. MGMT (O6-methylguanine DNA methyltransferase) is a gene that has been shown to help a glioma be more responsive to temozolomide when methylated. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether temozolomide is more effective with or without veliparib in treating glioblastoma multiforme. You will receive TMZ and placebo or TMZ and veliparib during the chemotherapy cycles.

Radiation therapy in combination with monoclonal antibody that prevents tumor blood vessel formation- Randomized Phase II Trial for Concurrent Bevacizumab and ReIrradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma
Physician: Fazilat Ishkanian, MD

This randomized phase II trial studies how well bevacizumab (commercially known as Avastin) with or without radiation therapy works in treating patients with recurrent glioblastoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Beva blocks the tumor ability to stimulate new blood vessels growth. Others find tumor cells and help kill them or carry cancer-killing substances to them. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet know whether bevacizumab is more effective with or without radiation therapy in treating patients with recurrent glioblastoma. In this study, you will receive bevacizumab every 2 weeks only or bevacizumab every 2 weeks and radiation therapy for 5 days a week for 2 weeks.

GBM Vaccine Trial- Dendritic Cell Vaccine for Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects
Physician: Macarena de la Fuente, MD

This trial for recurrent glioblastoma is looking at the ability of the immune system to target the tumor cells by first stimulating the immune system and then injecting the tumor cells to trigger your body to fight your tumor like an infection. You will receive 4 weekly vaccinations followed by 4 injections of your tumor lysates (every 4 weeks for the first 3 and then last injection 12 weeks later).
Each vaccination consists of 6 injections: 3 doses in each arm. Your tumor lysate is given as 2 injections.

Vaccine without or with monoclonal antibody that prevents tumor blood vessel formation- A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein Peptide COMPLEX 96 (HSPPC96) Vaccine Given With Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme
Physician: Ricardo Komotar, MD

This randomized phase II trial studies how well giving vaccine therapy with or without bevacizumab (Avastin) works in treating patients with recurrent glioblastoma multiforme that are eligible for surgery. Vaccines consisting of heat shock protein-peptide complexes made from a person’s own tumor tissue may help the body build an effective immune response to kill tumor cells that may remain after surgery. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them. It is not yet known whether giving vaccine therapy is more effective with or without bevacizumab in treating glioblastoma multiforme. In this study, patients will either get HSPPC-96 vaccine and bevacizumab; HSPPC vaccine first and then bevacizumab every 2 weeks if the tumor comes back; or bevacizumab alone.

Whole or localized brain radiation therapy- A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease
Physician: Fazilat Ishkanian, MD

In this trial reserved for brain metastases, a precise delivery of high level of radiation using localized SRS is given to the tumor site or the whole brain receives a small amount of radiation over time. You will either receive whole brain radiotherapy once a day for 5 days for a total of 3 weeks or you will undergo one 3D stereotactic radiosurgery procedure to remove tumor tissue using a high dose of ionizing radiation.

Investigational drug for GBM with IDH1 mutation- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Solid Tumors, Including Glioma, with an IDH1 Mutation AG 120-C-002
Physician: Jonathan Trent, MD, PhD

The purpose of this Phase I is to evaluate the safety and efficacy of clinical activity of AG-120 in gliomas that have an IDH1 mutation that have recurred or progressed following standard therapy, or that have not responded to standard therapy. IDH, an enzyme in the citric acid cycle, is mutated in a variety of cancers including gliomas; it initiates and drives cancer growth by both blocking cell differentiation and catalyzing the formation of 2-hydroxyglutarate. This investigational drug blocks the mutant IDH1 form in patients with glioblastoma that carry the IDH1 mutation. AG-120 dosage will be determined in this study. AG-120 is taken orally once a day, every day for up to 26 weeks.

Investigational drug for GBM with IDH2 mutation- Study of Orally Administered AG-221 in Subjects With Advanced Solid Tumors, Including Glioma, and With Angioimmunoblastic T-cell Lymphoma, With an IDH2 Mutation
Physician: Breelyn Wilky, MD

In this Phase I/II study, the safety and efficacy of AG-221 is evaluated in gliomas that have an IDH2 mutation that have recurred or progressed following standard therapy, or that have not responded to standard therapy. IDH, an enzyme in the citric acid cycle, is mutated in a variety of cancers including gliomas; it initiates and drives cancer growth by both blocking cell differentiation and catalyzing the formation of 2-hydroxyglutarate. This investigational drug blocks the mutant IDH2 form in patients with glioblastoma that carry the IDH2 mutation. AG-221 dosage will be determined in this study. AG-221 is taken orally once a day, every day for up to 26 weeks.

Electric fields to treat Glioblastoma- Post-approval Study of NovoTTF-100A in Recurrent GBM Patients
Physician: Deborah Heros, MD

This is a non-randomized, concurrent control study, designed to determine the efficacy of the NovoTTF-100A System in patients with recurrent GBM as compared to chemotherapy. NovoTTF-100A (Optune) is a portable, battery operated device for chronic treatment of patients with recurrent or progressive glioblastoma multiforme (GBM) using alternating electric fields (termed TTFields). NovoTTF-100A delivers low intensity, alternating “wave-like” electric fields that may interfere with multiplication of the glioblastoma multiforme cells. The device is worn continuously for 4-week courses.

IN SUPPORT OF YOUR CURRENT TREATMENT PLAN

A medication that reduces fatigue during treatment- A Phase III Randomized Double Blind Placebo Controlled Study of Armodafonil (Nuvigil) To Reduce Cancer Related Fatigue in Patients With High Grade Glioma
Physician: Deborah Heros, MD

This randomized phase III trial studies armodafinil (Nuvigil) to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma. In this study, you will receive either a placebo, dose 1 (150 mg) or dose 2 (250 mg) in the form of pill once a day for 8 weeks.

TREAMENT TRIALS WE WILL OFFER SOON

Electric fields to treat Meningioma- Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma (FALL 2015)
Physician: Macarena de la Fuente, MD

The purpose of this study is to find out what effects, good or bad, the Optune device (NovoTTF-100A) has on meningioma. This study is being done because currently there are no proven effective medical treatments for a progressive meningioma that has failed surgery and/or radiation. Optune or NovoTTF-100A is a portable, battery operated device that delivers a type of electric field therapy that may interfere with multiplication of the meningioma cells. In this study, you will need to wear this device for at least 18 hours per day, every day.

Gene Therapy Trial- Study of a Retroviral Replicating Vector to Treat Patients Undergoing Surgery for a Recurrent Malignant Brain Tumor (FALL 2015)
Physicians: Deborah Heros, MD and Noriyuki Kasahara, MD, PhD

This is a multicenter study evaluating the safety and tolerability of Toca 511 administered intracranially to patients with recurrent or progressive Grade III or Grade IV Gliomas who have elected to undergo surgical removal of their tumor. Toca 511 is a retroviral replicating vector that expresses the cytosine deaminase (CD) gene. CD converts the antibiotic 5-fluorocytosine (5-FC) to the anti-cancer drug 5-fluorouracil (5-FU) in cells that have been infected by the Toca 511 vector. This form of gene therapy forces the brain tumor itself to generate the toxic chemotherapy drug right inside its own cells.
First dose is given at time of surgery and then 6 weeks later. 5-FC is taken orally for 7 days every 4 weeks.

Questions regarding our trials?
Heleven Delgado, RN, MSN
UMBTI Nurse Navigator
Office: 305.243.4235
Fax: 305.243.5303
Email: HDelgado@med.miami.edu

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For a detailed list of all the trials offered at Sylvester:
Sylvester List for Brain and Nervous System Trials

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