Brain Tumor Trials Collaborative

Open BTTC Clinical Trials

An open trial follows a predefined protocol with the research team and the patient understanding the complete details of the program. Specifically, regarding the BTTC, current studies will investigate the effectiveness and safety of two treatment regimens — the Avastin/Tarceva Study and the Temodar Combination Study — involving malignant gliomas, the most common type and the most aggressive of adult brain tumors. The three-year survival rate of glioblastoma multiforme patients is less than two percent.

The clinical trial, which includes doctors, nurses and other health-care professionals, involves: an initial review of the patient's condition or overall health; monitoring the patient during the trial; and maintaining post-trial contact with the patient.

Benefits and risks are part of any clinical trial:

• Patient benefits
  • Active role in patient's health care
  • Access to new treatments before being widely introduced
  • Receive top-level care at leading medical institutions
  • Play a valuable role in medical research with potential to help patients facing similar health challenges
• Patient risks
  • Potential unpleasant side effects (including headache, nausea, hair loss or skin irritation)
  • May not be effective or produce the desired result
  • Possibly involves greater time commitment than non-trial treatment

Additional clinical trial information:

• Participatory guidelines exist and these are commonly known as inclusion/exclusion criteria (more participation details below regarding the BTTC open trials)
• All U.S. clinical trials are approved and tracked by an institutional review board to ensure risks are as minimal as possible and are worth the benefits
• Participants should be well-informed and understand as much as possible about the clinical trial and feel comfortable asking questions of the trial's health care team. A few general questions:
  • Who is in the study?
  • How do the potential side effects and benefits compare with my current treatment?
  • How might this trial affect my daily life?
  • Will hospitalization be required?
  • Who will be in charge of my care?

Avastin/Tarceva Study
The study will evaluate the effects and determine overall survival rates of newly diagnosed malignant glioma patients when administering a combination of bevacizumab (Avastin) and erlotinib (Tarceva) following the completion of radiation therapy with temozolomide (Temodar).

Other Avastin/Tarceva study objectives include:

• Determine the 12- and 18-month progression free survival
• Assess radiographic response rates
• Assess changes in tumor blood flow
• Collect safety data regarding the bevacizumab-erlotinib combination treatment following radiation and temozolomide

Participants will remain in the study as long as they do not experience disease progression or incur unacceptable toxicity levels.

Participating Doctors
The following members will be participating in the Avastin/Tarceva Study:

• Dr. Jeffrey Raizer, Northwestern University, Feinberg School of Medicine
• Dr. Sean Grimm, Northwestern University
• Dr. Mark Gilbert, University of Texas M.D. Anderson Cancer Center
• Dr. Elizabeth Maher, UT Southwestern Medical Center — Dallas
• Dr. Pamela New, The Methodist Hospital System
• Dr. Nina Paleologos, Northshore University Healthcare System
• Dr. George Bobustuc, M.D. Anderson Cancer Center — Orlando
• Dr. Marc Chamberlain, University of Washington
• Dr. David Schiff, University of Virginia

The Temodar Combination Study
The study will determine if temozolomide (Temodar) administered alone or in combination with thalidomide (Thalomid™), isotretinion (Accutane) and/or celecoxib (Celebrex) is effective in the continued treatment of newly diagnosed glioblastoma multiforme patients who already have incurred radiation therapy. Also, the toxicity of this adjuvant treatment will be studied.
Approximately 176 patients will participate in the study, which lasts up to one year and possibly beyond if the doctor determines it necessary. The effectiveness will be measured in terms of progression-free survival six months after the described treatment.

Participating Doctors
The following members will be participating in the Temodar Combination Study:

• Dr. Mark Gilbert, University of Texas (UT) M.D. Anderson Cancer Center
• Dr. W.K. Alfred Yung, UT M.D. Anderson Cancer Center
• Dr. Karen Fink, Baylor University Medical Center — Dallas
• Dr. Pamela New, The Methodist Hospital System
• Dr. Nina Paleologos, Northshore University Healthcare System
• Dr. Jeffrey Raizer, Northwestern University, Feinberg School of Medicine
• Dr. Pierre Giglio, Medical University of South Carolina
• Dr. Omid Hamid, The Angeles Clinic and Research Institute
• Dr. Elizabeth Maher, UT Southwestern Medical Center — Dallas

Participation and Screening Process
Prior to performing any of the study's related procedures, the research team provides the patient with the complete information necessary to make a proper decision about participating in the study. The process is known as the Informed Consent. A signed Informed Consent Form (ICF) by the patient is mandatory before performing any procedures.

Subsequent to the signed ICF, the patient begins the screening process, conducted in order to determine patient participation eligibility. Each study includes a list of inclusion and exclusion criteria with a unique list tailored to the respective treatment being studied.

Inclusion Criteria
The following inclusion criteria are typical of conditions that must be met for the patient's participation:

• Determining the type of disease
• Reviewing the complete and relevant medical history
• Knowledge of any prior treatments

Also, within cancer research studies, several medical tests are conducted:

• Blood and urine tests that reveal several aspects about the patient's health
• MRI tests to confirm the patient's diagnosis
• Possibly obtaining a tumor tissue sample to confirm the diagnosis

The patient may also participate in a question-and-answer session to assist the research team to further understand the overall situation of the patient.

Exclusion Criteria
The following exclusion criteria conditions may prevent the patient's participation:

• Medical conditions or illnesses, current or past
• Current or past treatments that might cause undue complications upon participation in the treatment regimen
• Results of tests mentioned in the inclusion criteria above can be determining factors
• Pregnancy status
• Mental status

Foremost, the screening process ensures the safety and well-being of the patient. The intent of the process is to find the appropriate treatment for the patient's specific disease, but the process also assists in obtaining relevant information about the disease being studied.