Conditions: Glioblastoma Multiforme
Keywords: GBM brain tumor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether the addition of an investigational medication, axitinib, to radiation therapy will improve the outcome of treatment in patients, above the age of 70.

Detailed description:
The addition of axitinib to standard treatment is experimental and has not been approved by the United States Food and Drug Administration (FDA). Axitinib works by preventing new blood vessels from forming, and tumors need to make new blood vessels in order to grow. The study will find out what effects, good or bad, axitinib has on the tumor. In addition, this study will try to determine whether the response to axitinib and the overall outcome depends on certain characteristics of your tumor.

Arms:
arm 1: Axitinib 5mg twice daily for 28 days followed by concurrent axitinib plus hypofractionated radiation therapy (45 Gy in 15 fractions) followed by maintenance axitinib 5mg twice daily until progression or unacceptable toxicity

Interventions: intervention 1: Axitinib intervention 2: Radiation Therapy
Intervention descriptions: intervention 1: 5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity intervention 2: 45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Protocol document: