NRG-BN011: Can a Second Chemotherapy Drug in Addition to Standard Radiation and Temozolomide Extend Your Life or Prevent the Growth and Spread of Your Brain Tumor?

If you over the age of 18 with a type of brain tumor called a glioblastoma and you have not yet received treatment for your glioblastoma, you may be able to participate.

This study is being done to determine if we can extend your life and lengthen time without your brain tumor returning or growing by adding the chemotherapy drug lomustine (Gleostine) to usual treatment.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your brain tumor. The usual approach is defined as care most people get for glioblastoma brain tumors.

You will receive surgery to remove your tumor as part of the usual treatment for your cancer.

If you decide to take part in this study, your study doctor will use some of the tissue removed during your surgery for two purposes: 1) to confirm at a central laboratory that your tumor is glioblastoma, and 2) to see if the tumor has a biomarker called “methylated” MGMT. A biomarker is a change in the tumor’s genes that gives information about how the tumor may respond to treatment. The MGMT methylation test helps predict if the tumor will respond to the drug, temozolomide. MGMT methylated tumors are more likely to respond to temozolomide chemotherapy.

You and your study doctor will get the results of the testing. If glioblastoma is not confirmed and/or your tumor does not have the methylated MGMT biomarker or there is not enough tissue to see whether you have the methylated MGMT biomarker, you will not be able to receive treatment on the study. However, if your tumor has an unmethylated MGMT biomarker, you may be able to participate in another study. Please discuss with your doctor. Your doctor will discuss other treatment options with you.

If you have confirmed glioblastoma and the methylated MGMT biomarker, you will either get:

• The usual treatment of radiation and temozolomide for 6 weeks, followed by temozolomide alone for up to 6 months, or 
• The usual treatment of radiation for 6 weeks plus the chemotherapy drugs temozolomide and lomustine (Gleostine) every 6 weeks for up to 9 months.

The usual approach for patients who are not in a study is surgery followed by treatment with radiation and a Food and Drug Administration (FDA)-approved drug called temozolomide, followed by temozolomide alone. Some patients also use an FDA-approved device called Optune to accompany the usual treatment. Optune is a portable device that uses electrodes applied to a patient’s head to send electric signals that could slow or stop cancer cell growth.

If you choose to take part in this study, there is a risk that:

• You may lose time at work or home and spend more time in the hospital or doctor’s office than usual. 
• You may be asked sensitive or private questions which you normally do not discuss. 
• The study drug may not be as good as the usual approach for your cancer at shrinking or stabilizing your cancer and preventing your cancer from spreading. 
• The drug used on this trial may cause side effects. Your doctor will review all of the potential side effects with you. It is important to tell your doctor about any side effects during the study so that they may be treated and so that potential adjustments to the study drugs may be made.

There is preliminary evidence that this treatment is effective in shrinking or stabilizing your type of cancer. It is not possible to know now if the study approach will extend your life or extend your time without disease compared to the usual approach. This study may help the study doctors learn things that may help people with your type of cancer in the future.

The group receiving the usual treatment followed by temozolomide will receive treatment for up to 6 months.

The group receiving the usual treatment plus temozolomide and the study drug lomustine (Gleostine) will receive treatment for up to 9 months.

After you finish your treatment, your doctor and study team will watch you for side effects and your tumor status. They will check you every 3 months for 1 year after treatment. After that, they will check you every 4 months for the second year of treatment and then every 6 months for your lifetime.

No. Taking part in this study is voluntary. You are free to choose to participate or not to participate. If you choose to participate in this study, you are able to leave the study at any time. If you decide not to take part in this study, your doctor will discuss other treatment options with you.

You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer.

This includes:

• the costs of tests, exams, procedures, and drugs that you get during the study to monitor your safety and prevent and treat side effects. 
• the costs of radiation therapy. 
• the costs of temozolomide. 
• your insurance co-pays and deductibles.
  Talk to your insurance provider and make sure that you understand what your insurance pays for and what it doesn’t pay for if you take part in this clinical trial. Also, find out if you need approval from your plan before you can take part in the study. 

You will not be paid for taking part in this study.

Your privacy is very important to us and the researchers will make every effort to protect it. Your information may be given out if required by law. For example, certain states require doctors to report to health boards if they find a disease like tuberculosis. However, the researchers will do their best to make sure that any information that is released will not identify you. Some of your health information and/or information about your specimens from this study will be kept in a central database for research. Your name or contact information will not be put in the database.

There are organizations that may inspect your records. These organizations are required to make sure your information is kept private, unless required by law to provide information. Some of these organizations are:

• NRG Oncology (study sponsor). 
• The NCI Central IRB, which is a group of people who review the research with the goal of protecting the people who take part in the study. 
• The FDA and the groups it works with to review research. 
• The NCI and the groups it works with to review research. 
• The NCI’s National Clinical Trials Network and the groups it works with to conduct research, including the Imaging and Radiation Oncology Core (IROC). 
• Tri-Source Pharma, LLC, the manufacturer of lomustine (Gleostine).

Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.

Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.

Yes. They are exactly the same thing.

The care cancer doctors provide to cancer patients today is the direct result of clinical studies (also known as clinical trials) that were done in the past. Clinical studies give doctors and the treatment team information about what types of treatments work and what treatments do not work, in a number of different situations. Some studies focus on treating the cancer, others on preventing the cancer, and others on helping patients feel better or healthier during or after treatments. When you take part in a clinical study, you add to our knowledge about cancer and it may help improve cancer care for future patients. Clinical studies are available to patients with many types of cancer and at all stages of treatment. In some situations, the only way to get these new treatments is by joining a clinical study.

A clinical study may take place in many locations, such as:

A study is typically led by a principal investigator who is a doctor or other advanced health care professional. A clinical study is carried out by following a very specific plan known as the “protocol”. The protocol is designed so all patients in the study are treated as well as possible and in the same way. The protocol also provides rules for the doctors and clinical study staff to follow to keep patients safe and make sure the study is run in an ethical manner.

No, not at all. Participation in a clinical study is completely voluntary. For more information see “Deciding to Take Part in a Clinical Trial”. You are free to choose to participate or not to participate. If you choose to participate in a study, you may still decide to leave the study at any time. If you decide not to participate in a study, your doctor will discuss other treatment options with you. For more information see “Questions to Ask Your Doctor about Treatment Clinical Trials“.

• You may choose to have the usual treatment approach (known as “standard of care”)
• You may choose to take part or learn more about a different study, if one is available
• You may choose not to be treated for cancer