About the STELLAR trial

The STELLAR trial is now recruiting patients with recurrent anaplastic astrocytoma.

The purpose of the STELLAR trial is to compare the efficacy and safety of oral eflornithine in combination with oral lomustine, compared to oral lomustine taken alone, in treating patients with AA that has recurred or progressed after radiation therapy and temozolomide (Temodar®) chemotherapy. STELLAR is a phase 3, randomized, open-label clinical trial. The primary outcome measure is overall survival.

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

Orbus Therapeutics is the sponsor of the STELLAR trial.

 

 

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).

About Eflornithine

Eflornithine, also known as α-diflurormethylornithine (DFMO) selectively targets and irreversibly inhibits ornithine decarboxylase (ODC), an enzyme essential for polyamine synthesis, and DNA and RNA function.  Unlike multi-targeted tyrosine kinase inhibitors on the market or in development today, eflornithine targets only one enzyme, ODC.

Eflornithine injection was approved by the FDA in 1990 for the treatment of African trypanosomiasis (sleeping sickness), but it was never made commercially available in the U.S. In 2000, the FDA approved a topical eflornithine cream for the reduction of unwanted facial hair in women.

Eflornithine oral solution is an investigational product that has not been proven to be safe and effective in treating patients with recurrent anaplastic astrocytoma (rAA).  Eflornithine oral solution may only be administered to patients who participate in the STELLAR trial. Eflornithine oral solution is not licensed for the treatment of rAA in the United States or any other country.

In animal studies, eflornithine has been shown to inhibit the growth of malignant tumors, including intra cerebral high-grade gliomas. Eflornithine administration has also been shown to potentiate the anti-tumor activity of other chemotherapy agents. 

In controlled, randomized, and single-arm clinical trials enrolling patients with newly diagnosed anaplastic astrocytoma (AA) or rAA,1 2 3 4 treatment with eflornithine oral solution increased survival. In these clinical trials, the primary and reversible side effects of eflornithine use in a small percentage of patients were diarrhea and hearing loss.

In 2014, Orbus Therapeutics received breakthrough therapy designation from the FDA for eflornithine for the treatment of patients with anaplastic glioma. A new drug may be designated as a breakthrough therapy by the FDA if it is intended to treat a serious or life-threatening disease and preliminary evidence suggests it provides substantial improvement over existing therapies. 

 

 

References


1. Shantz LM and Levin VA. Regulation of ornithine decarboxylase during oncogenic transformation: mechanisms and therapeutic potential. Amino Acids. 2007;33(2):213-223.

2. Levin VA, Prados MD, Yung WK, Gleason MJ, Ictech S, Malec M. Treatment of recurrent gliomas with eflornithine. J Natl Cancer Inst. 1992;84(18):1432-1437.

3. Levin VA, Hess KR, Choucair A, Flynn PJ, Jaeckle KA, Kyritsis AP, Yung WK, PradosMD, Bruner JM, Ictech S, Gleason MJ, Kim HW. Phase III randomized study of post radiotherapy chemotherapy with combination alpha-difluromethylornithine-PCV versus PCV for anaplastic gliomas. Clin Cancer Res. 2003;9(3):981-990

4. Levin VA, Ictech SE, Hess KR. Clinical importance of eflornithine (α-difluoromethylornithine) for the treatment of malignant gliomas. CNS Oncology. Published Online: 30 Jan 2018. https://www.futuremedicine.com/doi/10.2217/cns-2017-0031

 

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 maybe 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: National Organization of Rare Disorders website 

https://rarediseases.org/rare-diseases/anaplastic-astrocytoma/

 
 
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Is my patient eligible for the STELLAR clinical trial?

A patient may be eligible now if:

  They have WHO grade 3 anaplastic astrocytoma (AA) or WHO grade 3 anaplastic oligoastrocytoma

  They are 18 years of age or older

  This is the first recurrence or progression of disease

  First AA recurrence or progression has occurred within the past 3 months

  They have already been treated with temozolomide (Temodar®) 

  They completed radiation therapy more than 6 months ago

  They have not been treated with any additional systemic therapy

 

A patient may be eligible in the future if:

They currently have WHO grade 2 astrocytoma or oligoastrocytoma that progresses to WHO grade 3 AA. Consider rapid referral to the STELLAR trial for patients who progress from grade 2 to grade 3 and meet the eligibility criteria above.

A detailed list of inclusion and exclusion criteria for the STELLAR trial is available here.

The World Health Organization published new guidelines in 2016¹ for the classification and grading of central nervous system tumors.

Reference

1. Louis DN, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee WK,Ohgaki H, Wiestler OD, Kleihues P, Ellison DW. The 2016 World Health Organization classification of tumors of the central nervous system: a summary. Acta Neuropathol 2016;131(6):803-820.

 

How do I refer a patient to 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.

 

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

 

 

 

To reach a member of the STELLAR trial team, please provide your contact information and location. A representative from a clinical trial site or Orbus Therapeutics will be in touch with you as soon as possible.

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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 throughout 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.