Q: WHAT IS THE PURPOSE OF THIS TRIAL?
A: The primary objective of this Phase III study is to evaluate the efficacy of Tf-CRM107 compared to best standard of care. Other objectives include an assessment of safety compared to best standard of care, and an evaluation of the differences in efficacy and safety of Tf-CRM107.

Q: WHAT ARE THE BEST STANDARD OF CARE AGENTS BEING USED IN THIS TRIAL?
A: Best standard of care agents used in this trial are:
• Platinum based chemotherapy (Cisplatin, Carboplatin)
• Temozolomide
• Nitrosoureas (ACNU, BCNU, CCNU)
• Procarbazine
• PCV (Procarbazine, CCNU, Vincristine)

Q: WHAT ARE THE CURRENT TREATMENT OPTIONS FOR GBM?
A: Surgery is the chief form of treatment for a GBM tumour that can be removed without damaging critical neurological functions. Because a tumour will recur if any tumour cells are left behind, the surgeon's goal is to remove the entire tumour whenever possible. Radiation therapy and chemotherapy, in general, are used as secondary or adjuvant treatment for tumours that cannot be cured by surgery alone.

Steroids and anti-convulsants are the most common medications used for brain tumour patients. Steroids are given to reduce inflammation of tissues and control swelling of the brain, particularly before and after surgery. They do not kill tumour cells, but may improve a patient's condition when used alone or in combination with other forms of treatment. Anti-convulsants are used to keep seizures from occurring or cut short seizures that have already started. It is important to remember that side effects of these drugs vary greatly from person to person.

Radiation therapy is primarily used after surgery for tumours that cannot be removed completely, as well as for cases in which surgery would involve too great a risk to the patient. Radiation may be given in a single dose each day, usually for 30 days with weekends off, or it may be "hyperfractionated" into two or more doses daily for the recommended course of treatment.

Standard radiation therapy delivers an external beam of radiation aimed at an entire region, such as the portion of the brain containing the tumour and typically delivers a daily dose of 1.8-2.0 Gy (Gray) to a total dose of 50-60 Gy over 5-7 weeks.

Chemotherapy works to destroy tumour cells with drugs that may be given either alone or in combination with other treatments. A key problem with chemotherapy has been the difficulty in delivering sufficient amounts of drug directly to the tumour while sparing normal brain cells. Another problem is the blood-brain barrier mechanism that normally keeps harmful substances out of the brain - unfortunately, this same blood-brain barrier can also keep potentially helpful drugs out of the brain. Although chemotherapy is typically given orally or injected in the vein, some new techniques of intratumoural chemotherapy use either small pumps or biodegradable wafers to place the drug inside the tumour.

Stereotactic radiosurgery, also known as "gamma-knife," is a non-invasive therapeutic alternative for treating brain disorders. Instead of a scalpel, clinicians using stereotactic radiosurgery technology to aim multiple "pencil-thin" beams or arched beams of high-energy particles directly at the tumour site, while sparing as much healthy tissue as possible.

Q: HOW CAN I TAKE PART IN THE TF-CRM107 TRIAL?
A: In order to ascertain whether you are eligible for this trial, please visit the Are You Eligible page which outlines the main inclusion and exclusion criteria. If you believe you are eligible, then you should contact your doctor to discuss the possibility of enrolling in the trial.

Q: IF I ENROL IN THE STUDY WILL I DEFINITELY RECEIVE TF-CRM107?
A: No. The Tf-CRM107 Phase III study is randomised. This means that 2 out of 3 patients will receive the trial drug, whilst 1 out of 3 will receive best standard of care; therefore there is no guarantee that any single patient will receive Tf-CRM107.

Q: HOW MANY PEOPLE HAVE USED TF-CRM107?
A: Approximately 70 patients to date, not including patients currently enrolled in the Phase III trial.

Q: HOW LONG DOES THE TREATMENT LAST AND HOW LONG WILL I BE IN HOSPITAL FOR?
A: Treatment with Tf-CRM107 involves the insertion of two small catheters into the tumour site, which enables the slow and constant infusion of the trial drug directly to the tumour. Two infusions will be given between four and eight days apart. The length of each infusion will take from four to seven weeks. In addition, after the second infusion, you will be asked to return to the clinic on a monthly basis for six months to undergo follow-up examinations.

Q: WHAT IS A PROTOCOL?
A: A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants, as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications and dosages; and the length of the study.

Q: CAN I LEAVE A TRIAL ONCE IT HAS BEGUN?
A: You are free to withdraw from any clinical trial at any time without giving a reason. This will not affect the care that you receive from your doctor.

Q: I DON'T WANT TO PARTICIPATE IN THE TRIAL, CAN I HAVE TF-CRM107 ANYWAY?
A: As Tf-CRM107 is not a licensed drug, at this time we cannot provide it to anyone not participating in the clinical trials.