Recurrent Anaplastic Astrocytoma (rAA) Brain Cancer

ABOUT THE STELLAR STUDY

Brain cancer experts at Orbus Therapeutics are conducting a clinical study to evaluate the use of *eflornithine oral investigational medicine as a targeted therapy for treating recurrent anaplastic astrocytoma, a rare brain cancer. In the STELLAR study, eflornithine is a take home oral investigational medicine.

Who is eligible?

Patients with anaplastic astrocytoma (AA) that has recurred or progressed after radiation therapy, and chemotherapy may be eligible to participate. To see if you may qualify, click here to complete the inquiry form.

Study Locations

The STELLAR study is being carried out at selected medical centers in the United States, Canada, Belgium, Germany, Italy, United Kingdom, France and Netherlands. To see center locations, click here. Resources are available to assist patients with costs associated with study participation.

Patient Inquiry form

ABOUT THE DISEASE

What is Anaplastic Astrocytoma (AA)?

Anaplastic Astrocytoma is a rare form of brain cancer that 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 molecular biomarker analysis.

What is Recurrent Anaplastic Astrocytoma (rAA)?

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

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TREATMENT

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.

What is eflornithine?

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). Eflornithine is a molecule that targets a key enzyme called ornithine decarboxylase. Ornithine decarboxylase plays a role in cancer cell growth.

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 an investigational product, meaning it 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. Eflornithine oral investigational medicine has not been proven to be safe and effective in treating patients with recurrent anaplastic astrocytoma (or rAA). Eflornithine oral investigational medicine may only be administered to patients who participate in a research study. Eflornithine oral investigational medicine 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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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.