Phase II Axitinib (AG-013736) in Elderly Glioblastoma Multiforme (GBM) Patients

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01508117
• Other study ID #: UCCR-2
• Status: Terminated
• Phase: Phase 2
• First received: January 6, 2012
• Last updated: August 18, 2017
• Start date: August 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2014
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• Axitinib
5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity

Radiation:
• Radiation Therapy
45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		average 1 year