What is the STELLAR trial?

Better treatment options are needed for patients with recurrent anaplastic astrocytoma (or rAA).

The purpose of the STELLAR trial is to study eflornithine oral solution as a possible new treatment for patients with rAA, and the trial is now open for enrollment.

In the STELLAR trial, patients with rAA will receive treatment with either eflornithine in combination with lomustine, or lomustine by itself. Patients are randomly assigned to one of the two treatment groups. Treatment lasts up to 12 or 24 months, depending on the treatment group. Treatment is followed by an observation period for up to 24 months.

The STELLAR trial is registered with the United States Government clinical trials registry and with the European Union Clinical Trials Registry.

For more information about the STELLAR trial on the United States Government clinical trials registry, click here 

To find information about the STELLAR trial in the European Union Clinical Trials Register, click here

 

Anaplastic Astrocytoma (or AA) is a rare form of brain cancer. AA develops from astrocytes, a type of cell that normally wraps and protects nerves in the brain and spinal cord. The specific cause of AA is not known. Most AAs grow slowly over time, but some grow quickly. Some AAs transform to become a more aggressive type of tumor called glioblastoma.

AA is most common in adults aged 30 to 50 years, although it can affect all ages. A detailed list of symptoms, complete physical exam, and imaging tests, such as an MRI or a CT scan of the brain, are part of the medical evaluation. The diagnosis of AA may be confirmed by collecting tumor tissue during surgery for inspection under a microscope and for specialized genetic tests.

Surgery, radiation therapy, and chemotherapy can be used alone or together to treat AA. Treatment usually begins with surgery to reduce the size of the tumor. Surgery is usually followed by radiation therapy and chemotherapy with temozolomide (the generic drug name for Temodar®). The type and sequence of therapies may be different for each patient, depending on each unique situation.

When the tumor starts to grow after treatment, AA is called recurrent anaplastic astrocytoma (or rAA).  Currently, there are very few therapies for patients with rAA or AA that has progressed (grown larger or changed in appearance).

Source: NORD  National Organization of Rare Disorders website

 

Our product candidate, eflornithine, is a novel cytostatic (growth inhibiting) agent, which we are developing for the potential treatment of patients with anaplastic astrocytoma (AA).

What is eflornithine?

In research studies of humans and animals, eflornithine has been shown to delay or stop the growth of brain cancer and other kinds of cancer cells. Eflornithine is a molecule that targets a key enzyme called ornithine decarboxylase. Ornithine decarboxylase plays a role in cancer cell growth.

In the STELLAR trial, eflornithine is given as a liquid medication that is swallowed 3 times per day. Eflornithine oral solution is an investigational product that has not been proven to be safe and effective in treating patients with recurrent anaplastic astrocytoma (or rAA). Eflornithine oral solution may only be administered to patients who participate in a research trial. Eflornithine oral solution is not licensed for the treatment of rAA in the United States or any other country.

What is lomustine?

Lomustine is the generic drug name for CCNU (also called CeeNU® or Gleostine®), a chemotherapy drug that is used to treat certain types of cancers, including brain cancers. It is often used to treat patients with rAA in clinical practice. Lomustine is not specifically licensed for the treatment of rAA in the United States or in any other country.

Lomustine belongs to the class of chemotherapy drugs called alkylating agents. Alkylating agents affect the DNA in cells and delay or stop cell growth. Lomustine capsules are taken by mouth once every 6 weeks

 

 

 
 
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Am I eligible to participate in the STELLAR trial?

You may be eligible if:

  Your doctor has told you that you have anaplastic astrocytoma

  You have already been treated with radiation and a chemotherapy drug called temozolomide (also known as Temodar®)

  Your doctor has told you that the tumor has recurred (come back) or has progressed (grown or changed) within the past 3 months

  You completed radiation therapy more than 6 months ago 

  You are an adult over the age of 18 years old


Patient Inquiry Information

 

 

Eflornithine is an investigational product. An investigational product is one that has not been proven to be safe and effective for this use and is not licensed by the US Food and Drug Administration or any other government agency. An investigational product can only be administered in a research study.

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Below are links for additional patient information:

 www.centerwatch.com

www.virtualtrials.com

 (American Brain Tumor Association) www.abta.org

(International Brain Tumor Society) www.theibta.org

(National Brain Tumor Society) http://braintumor.org

(ABC2) www.abc2.org

(National Organization of Rare Disorders) www.rarediseases.org

 

Public Facebook pages:

Stellar Study Facebook Page https://www.facebook.com/STELLARstudy/

BrainCancerMoonshot  https://www.facebook. com/groups/1202877546407969/

Hope for Grey Matters  https://www. facebook.com/ HopeForGreyMatters/

 

Private Facebook pages:

Astrocytoma Brain Cancer  https://www. facebook.com/search/top/?q= astrocytoma%20brain%20cancer

Anaplastic Astrocytoma  https:// www.facebook.com/search/top/? q=anaplastic%20astrocytoma% 20brain%20cancer

Braintrust.org  http://braintrust. org/

 

 

Where are the STELLAR trial sites located?

Currently, the STELLAR trial is being carried out at selected medical centers in the United States, Canada, Belgium, Germany, Italy, and Netherlands. To see where these centers are located, click here. Resources are available to assist patients with costs associated with trial participation.


How can I find out more about participating in the STELLAR trial?

Click here to contact a member of the STELLAR trial research team. A representative from a clinical trial site or Orbus Therapeutics will be in touch with you as soon as possible.

For more information about the STELLAR trial on the United States Government Clinical Trials Registry.

To find information about the STELLAR trial in the European Union Clinical Trials Register.

 


Orbus Therapeutics

Orbus Therapeutics is dedicated to exploring new treatment options for patients with recurrent anaplastic astrocytoma, a rare form of brain cancer. Helping patients who are facing life-threatening or life-altering diseases is our passion and focus.

The team of experts at Orbus Therapeutics includes Victor A. Levin, MD, chairman of the Orbus Therapeutics clinical advisory board and senior medical advisor to Orbus Therapeutics. Dr. Levin has studied the use of eflornithine in brain cancers during his career. Dr. Levin is the former chair of the Department of Neuro-Oncology at M.D. Anderson Cancer Center, where he also served as the Bernard W. Biedenham Chair for Cancer Research. In 1995, he founded the Society for Neuro-Oncology, an international organization with more than 2,400 members. He has authored more than 380 publications, including Cancer in the Nervous System, the first comprehensive medical textbook in neuro-oncology.

 

 

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