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A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)


Phase 2
70 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

A Phase II Window Study of Front-line Axitinib Followed by Axitinib and Radiation for Elderly Patients With Glioblastoma Multiforme (GBM)


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.


Inclusion Criteria:



- Newly diagnosed patients with histologically proven glioblastoma multiforme

- Age above 70 years

- Karnofsky score of 50-80

- Adequate organ function as defined by laboratory values

- Life expectancy of >12 weeks

- No evidence of preexisting uncontrolled hypertension as documented by 2 baseline
blood pressure readings taken at least 1 hour apart. The baseline systolic blood
pressure readings must be 140 mm Hg, and the baseline diastolic blood pressure
readings must be 90 mm Hg. Patients whose hypertension is controlled by
antihypertensive therapies are eligible.

Exclusion Criteria:

- Prior treatment with chemotherapy or radiation for glioblastoma multiforme

- Patients with extensive tumor hemorrhage

- Any of the following within the 12 months prior to study drug administration:
myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft,
symptomatic congestive heart failure, cerebrovascular accident or transient ischemic
attack and 6 months for deep vein thrombosis or pulmonary embolism

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

average 1 year

Safety Issue:

No

Principal Investigator

Olivier Rixe, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati

Authority:

United States: Food and Drug Administration

Study ID:

UCCR-2

NCT ID:

NCT01508117

Start Date:

January 2012

Completion Date:

June 2016

Related Keywords:

  • Glioblastoma Multiforme
  • GBM
  • brain tumor
  • Glioblastoma

Name

Location

University of CincinnatiCincinnati, Ohio  45267-0502