OT-15-001 ORBUS STELLAR Study - Ph 3 Eflornithine + Lomustine (Brain Cancer) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if eflornithine is safe and will work when it is taken with lomustine when compared to taking lomustine alone for patients diagnosed with anaplastic astrocytoma.

What is the Condition Being Studied?

Brain Cancer (WHO [World Health Organization] Grade 3 Anaplastic Astrocytoma)

Who Can Participate in the Study?

Adults who have been diagnosed with WHO Grade 3 anaplastic astrocytoma that progressed or recurred for the first time after standard radiation and chemotherapy

Age Group

Adults

What is Involved?

If you choose to be in this study, you will:

- Be randomly (like a flip of a coin) assigned to one of two groups:

-- Group A will get eflornithine and lomustine
--- Complete a 6-week cycle and will repeat this cycle for a total of 2 years
--- Come to the clinic about every 3 months during the 2nd year

and

-- Group B will get lomustine only
--- Lomustine will be taken once every 6 weeks for up to 1 year
-- Come to the clinic about every 6 weeks for 6 months and then about every 10 weeks thereafter during the 1st year

Study Details

Full Title

A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy

Principal Investigator